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Start Preamble benicar best buy Centers for Medicare &. Medicaid Services (CMS), HHS. Extension of benicar best buy timeline for publication of final rule. This notice announces an extension of the timeline for publication of a Medicare final rule in accordance with the Social Security Act, which allows us to extend the timeline for publication of the final rule.

As of August 26, 2020, the timeline for publication of the final rule to finalize the provisions of the October 17, 2019 proposed rule (84 FR 55766) benicar best buy is extended until August 31, 2021. Start Further Info Lisa O. Wilson, (410) 786-8852. End Further Info End Preamble Start Supplemental Information In the October 17, 2019 Federal Register (84 FR 55766), we published a proposed rule that addressed undue regulatory benicar best buy impact and burden of the physician self-referral law.

The proposed rule was issued in conjunction with the Centers for Medicare &. Medicaid Services' (CMS) Patients over Paperwork initiative and the Department of benicar best buy Health and Human Services' (the Department or HHS) Regulatory Sprint to Coordinated Care. In the proposed rule, we proposed exceptions to the physician self-referral law for certain value-based compensation arrangements between or among physicians, providers, and suppliers. A new exception for certain arrangements under which a physician receives limited remuneration for items or services actually provided by the physician.

A new exception for donations of benicar best buy cybersecurity technology and related services. And amendments to the existing exception for electronic health records (EHR) items and services. The proposed rule also provides critically necessary guidance for physicians and health care providers benicar best buy and suppliers whose financial relationships are governed by the physician self-referral statute and regulations. This notice announces an extension of the timeline for publication of the final rule and the continuation of effectiveness of the proposed rule.

Section 1871(a)(3)(A) of the Social Security Act (the Act) requires us to establish and publish a regular timeline for the publication of final regulations based on the previous publication of a proposed regulation. In accordance with section 1871(a)(3)(B) of the Act, the timeline may vary among different regulations based on differences in the complexity of the regulation, the number and scope of comments received, and other relevant factors, but may not benicar best buy be longer than 3 years except under exceptional circumstances. In addition, in accordance with section 1871(a)(3)(B) of the Act, the Secretary may extend the initial targeted publication date of the final regulation if the Secretary, no later than the regulation's previously established proposed publication date, publishes a notice with the new target date, and such notice includes a brief explanation of the justification for the variation. We announced in the Spring 2020 Unified Agenda benicar best buy (June 30, 2020, www.reginfo.gov) that we would issue the final rule in August 2020.

However, we are still working through the Start Printed Page 52941complexity of the issues raised by comments received on the proposed rule and therefore we are not able to meet the announced publication target date. This notice benicar best buy extends the timeline for publication of the final rule until August 31, 2021. Start Signature Dated. August 24, 2020.

Wilma M benicar best buy. Robinson, Deputy Executive Secretary to the Department, Department of Health and Human Services. End Signature End Supplemental Information benicar best buy [FR Doc. 2020-18867 Filed 8-26-20.

8:45 am]BILLING CODE 4120-01-PStart Preamble Notice of amendment. The Secretary issues this amendment pursuant to section 319F-3 of the Public Health Service Act to add additional categories of Qualified Persons and amend the category of disease, health condition, or threat for which benicar best buy he recommends the administration or use of the Covered Countermeasures. This amendment to the Declaration published on March 17, 2020 (85 FR 15198) is effective as of August 24, 2020. Start Further benicar best buy Info Robert P.

Kadlec, MD, MTM&H, MS, Assistant Secretary for Preparedness and Response, Office of the Secretary, Department of Health and Human Services, 200 Independence Avenue SW, Washington, DC 20201. Telephone. 202-205-2882. End Further Info End Preamble Start Supplemental Information The Public Readiness and Emergency Preparedness Act (PREP Act) authorizes the Secretary of Health and Human Services (the Secretary) to issue a Declaration to provide liability immunity to certain individuals and entities (Covered Persons) against any claim of loss caused by, arising out of, relating to, or resulting from the manufacture, distribution, administration, or use of medical countermeasures (Covered Countermeasures), except for claims involving “willful misconduct” as defined in the PREP Act.

Under the PREP Act, a Declaration may be amended as circumstances warrant. The PREP Act was enacted on December 30, 2005, as Public Law 109-148, Division C, § 2. It amended the Public Health Service (PHS) Act, adding section 319F-3, which addresses liability immunity, and section 319F-4, which creates a compensation program. These sections are codified at 42 U.S.C.

247d-6d and 42 U.S.C. 247d-6e, respectively. Section 319F-3 of the PHS Act has been amended by the Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA), Public Law 113-5, enacted on March 13, 2013 and the Coronavirus Aid, Relief, and Economic Security (CARES) Act, Public Law 116-136, enacted on March 27, Start Printed Page 521372020, to expand Covered Countermeasures under the PREP Act. On January 31, 2020, the Secretary declared a public health emergency pursuant to section 319 of the PHS Act, 42 U.S.C.

247d, effective January 27, 2020, for the entire United States to aid in the response of the nation's health care community to the COVID-19 outbreak. Pursuant to section 319 of the PHS Act, the Secretary renewed that declaration on April 26, 2020, and July 25, 2020. On March 10, 2020, the Secretary issued a Declaration under the PREP Act for medical countermeasures against COVID-19 (85 FR 15198, Mar. 17, 2020) (the Declaration).

On April 10, the Secretary amended the Declaration under the PREP Act to extend liability immunity to covered countermeasures authorized under the CARES Act (85 FR 21012, Apr. 15, 2020). On June 4, the Secretary amended the Declaration to clarify that covered countermeasures under the Declaration include qualified countermeasures that limit the harm COVID-19 might otherwise cause. The Secretary now amends section V of the Declaration to identify as qualified persons covered under the PREP Act, and thus authorizes, certain State-licensed pharmacists to order and administer, and pharmacy interns (who are licensed or registered by their State board of pharmacy and acting under the supervision of a State-licensed pharmacist) to administer, any vaccine that the Advisory Committee on Immunization Practices (ACIP) recommends to persons ages three through 18 according to ACIP's standard immunization schedule (ACIP-recommended vaccines).[] The Secretary also amends section VIII of the Declaration to clarify that the category of disease, health condition, or threat for which he recommends the administration or use of the Covered Countermeasures includes not only COVID-19 caused by SARS-CoV-2 or a virus mutating therefrom, but also other diseases, health conditions, or threats that may have been caused by COVID-19, SARS-CoV-2, or a virus mutating therefrom, including the decrease in the rate of childhood immunizations, which will lead to an increase in the rate of infectious diseases.

Description of This Amendment by Section Section V. Covered Persons Under the PREP Act and the Declaration, a “qualified person” is a “covered person.” Subject to certain limitations, a covered person is immune from suit and liability under Federal and State law with respect to all claims for loss caused by, arising out of, relating to, or resulting from the administration or use of a covered countermeasure if a declaration under subsection (b) has been issued with respect to such countermeasure. €œQualified person” includes (A) a licensed health professional or other individual who is authorized to prescribe, administer, or dispense such countermeasures under the law of the State in which the countermeasure was prescribed, administered, or dispensed. Or (B) “a person within a category of persons so identified in a declaration by the Secretary” under subsection (b) of the PREP Act.

42 U.S.C. 247d-6d(i)(8).[] By this amendment to the Declaration, the Secretary identifies an additional category of persons who are qualified persons under section 247d-6d(i)(8)(B).[] On May 8, 2020, CDC reported, “The identified declines in routine pediatric vaccine ordering and doses administered might indicate that U.S. Children and their communities face increased risks for outbreaks of vaccine-preventable diseases,” and suggested that a decrease in rates of routine childhood vaccinations were due to changes in healthcare access, social distancing, and other COVID-19 mitigation strategies.[] The report also stated that “[p]arental concerns about potentially exposing their children to COVID-19 during well child visits might contribute to the declines observed.” [] On July 10, 2020, CDC reported its findings of a May survey it conducted to assess the capacity of pediatric health care practices to provide immunization services to children during the COVID-19 pandemic. The survey, which was limited to practices participating in the Vaccines for Children program, found that, as of mid-May, 15 percent of Northeast pediatric practices were closed, 12.5 percent of Midwest practices were closed, 6.2 percent of practices in the South were closed, and 10 percent of practices in the West were closed.

Most practices had reduced office hours for in-person visits. When asked whether their practices would likely be able to accommodate new patients for immunization services through August, 418 practices (21.3 percent) either responded that this was not likely or the practice was permanently closed or not resuming immunization services for all patients, and 380 (19.6 percent) responded that they were unsure. Urban practices and those in the Northeast were less likely to be able to accommodate new patients compared with rural practices and those in the South, Midwest, or West.[] In response to these troubling developments, CDC and the American Academy of Pediatrics have stressed, “Well-child visits and vaccinations are essential services and help make sure children are protected.” [] The Secretary re-emphasizes that important recommendation to parents and legal guardians here. If your child is due for a well-child visit, contact your pediatrician's or other primary-care provider's office and ask about ways that the office safely offers well-child visits and vaccinations.

Many medical offices are taking extra steps to make sure that well-child visits can occur safely during the COVID-19 pandemic, including. Scheduling sick visits and well-child visits during different times of the Start Printed Page 52138day or days of the week, or at different locations. Asking patients to remain outside until it is time for their appointments to reduce the number of people in waiting rooms. Adhering to recommended social (physical) distancing and other infection-control practices, such as the use of masks.

The decrease in childhood-vaccination rates is a public health threat and a collateral harm caused by COVID-19. Together, the United States must turn to available medical professionals to limit the harm and public health threats that may result from decreased immunization rates. We must quickly do so to avoid preventable infections in children, additional strains on our healthcare system, and any further increase in avoidable adverse health consequences—particularly if such complications coincide with additional resurgence of COVID-19. Together with pediatricians and other healthcare professionals, pharmacists are positioned to expand access to childhood vaccinations.

Many States already allow pharmacists to administer vaccines to children of any age.[] Other States permit pharmacists to administer vaccines to children depending on the age—for example, 2, 3, 5, 6, 7, 9, 10, 11, or 12 years of age and older.[] Few States restrict pharmacist-administered vaccinations to only adults.[] Many States also allow properly trained individuals under the supervision of a trained pharmacist to administer those vaccines.[] Pharmacists are well positioned to increase access to vaccinations, particularly in certain areas or for certain populations that have too few pediatricians and other primary-care providers, or that are otherwise medically underserved.[] As of 2018, nearly 90 percent of Americans lived within five miles of a community pharmacy.[] Pharmacies often offer extended hours and added convenience. What is more, pharmacists are trusted healthcare professionals with established relationships with their patients. Pharmacists also have strong relationships with local medical providers and hospitals to refer patients as appropriate. For example, pharmacists already play a significant role in annual influenza vaccination.

In the early 2018-19 season, they administered the influenza vaccine to nearly a third of all adults who received the vaccine.[] Given the potential danger of serious influenza and continuing COVID-19 outbreaks this autumn and the impact that such concurrent outbreaks may have on our population, our healthcare system, and our whole-of-nation response to the COVID-19 pandemic, we must quickly expand access to influenza vaccinations. Allowing more qualified pharmacists to administer the influenza vaccine to children will make vaccinations more accessible. Therefore, the Secretary amends the Declaration to identify State-licensed pharmacists (and pharmacy interns acting under their supervision if the pharmacy intern is licensed or registered by his or her State board of pharmacy) as qualified persons under section 247d-6d(i)(8)(B) when the pharmacist orders and either the pharmacist or the supervised pharmacy intern administers vaccines to individuals ages three through 18 pursuant to the following requirements. The vaccine must be FDA-authorized or FDA-approved.

The vaccination must be ordered and administered according to ACIP's standard immunization schedule.[] The licensed pharmacist must complete a practical training program of at least 20 hours that is approved by the Accreditation Council for Pharmacy Education (ACPE). This training Start Printed Page 52139program must include hands-on injection technique, clinical evaluation of indications and contraindications of vaccines, and the recognition and treatment of emergency reactions to vaccines.[] The licensed or registered pharmacy intern must complete a practical training program that is approved by the ACPE. This training program must include hands-on injection technique, clinical evaluation of indications and contraindications of vaccines, and the recognition and treatment of emergency reactions to vaccines.[] The licensed pharmacist and licensed or registered pharmacy intern must have a current certificate in basic cardiopulmonary resuscitation.[] The licensed pharmacist must complete a minimum of two hours of ACPE-approved, immunization-related continuing pharmacy education during each State licensing period.[] The licensed pharmacist must comply with recordkeeping and reporting requirements of the jurisdiction in which he or she administers vaccines, including informing the patient's primary-care provider when available, submitting the required immunization information to the State or local immunization information system (vaccine registry), complying with requirements with respect to reporting adverse events, and complying with requirements whereby the person administering a vaccine must review the vaccine registry or other vaccination records prior to administering a vaccine.[] The licensed pharmacist must inform his or her childhood-vaccination patients and the adult caregivers accompanying the children of the importance of a well-child visit with a pediatrician or other licensed primary-care provider and refer patients as appropriate.[] These requirements are consistent with those in many States that permit licensed pharmacists to order and administer vaccines to children and permit licensed or registered pharmacy interns acting under their supervision to administer vaccines to children.[] Administering vaccinations to children age three and older is less complicated and requires less training and resources than administering vaccinations to younger children. That is because ACIP generally recommends administering intramuscular injections in the deltoid muscle for individuals age three and older.[] For individuals less than three years of age, ACIP generally recommends administering intramuscular injections in the anterolateral aspect of the thigh muscle.[] Administering injections in the thigh muscle often presents additional complexities and requires additional training and resources including additional personnel to safely position the child while another healthcare professional injects the vaccine.[] Moreover, as of 2018, 40% of three-year-olds were enrolled in preprimary programs (i.e.

Preschool or kindergarten programs).[] Preprimary programs are beginning in the coming weeks or months, so the Secretary has concluded that it is particularly important for individuals ages three through 18 to receive ACIP-recommended vaccines according to ACIP's standard immunization schedule. All States require children to be vaccinated against certain communicable diseases as a condition of school attendance. These laws often apply to both public and private schools with identical immunization and exemption provisions.[] As nurseries, preschools, kindergartens, and schools reopen, increased access to childhood vaccinations is essential to ensuring children can return. Notwithstanding any State or local scope-of-practice legal requirements, (1) qualified licensed pharmacists are identified as qualified persons to order and administer ACIP-recommended vaccines and (2) qualified State-licensed or registered pharmacy interns are identified as qualified persons to administer the ACIP-recommended vaccines ordered by their supervising qualified licensed pharmacist.[] Both the PREP Act and the June 4, 2020 Second Amendment to the Declaration define “covered countermeasures” to include qualified pandemic and epidemic products that “limit the harm such pandemic or epidemic might otherwise cause.” [] The troubling decrease in ACIP-recommended childhood vaccinations and the resulting increased risk of associated diseases, adverse health conditions, and other threats are categories of harms otherwise caused by Start Printed Page 52140COVID-19 as set forth in Sections VI and VIII of this Declaration.[] Hence, such vaccinations are “covered countermeasures” under the PREP Act and the June 4, 2020 Second Amendment to the Declaration.

Nothing in this Declaration shall be construed to affect the National Vaccine Injury Compensation Program, including an injured party's ability to obtain compensation under that program. Covered countermeasures that are subject to the National Vaccine Injury Compensation Program authorized under 42 U.S.C. 300aa-10 et seq. Are covered under this Declaration for the purposes of liability immunity and injury compensation only to the extent that injury compensation is not provided under that Program.

All other terms and conditions of the Declaration apply to such covered countermeasures. Section VIII. Category of Disease, Health Condition, or Threat As discussed, the troubling decrease in ACIP-recommended childhood vaccinations and the resulting increased risk of associated diseases, adverse health conditions, and other threats are categories of harms otherwise caused by COVID-19. The Secretary therefore amends section VIII, which describes the category of disease, health condition, or threat for which he recommends the administration or use of the Covered Countermeasures, to clarify that the category of disease, health condition, or threat for which he recommends the administration or use of the Covered Countermeasures is not only COVID-19 caused by SARS-CoV-2 or a virus mutating therefrom, but also other diseases, health conditions, or threats that may have been caused by COVID-19, SARS-CoV-2, or a virus mutating therefrom, including the decrease in the rate of childhood immunizations, which will lead to an increase in the rate of infectious diseases.

Amendments to Declaration Amended Declaration for Public Readiness and Emergency Preparedness Act Coverage for medical countermeasures against COVID-19. Sections V and VIII of the March 10, 2020 Declaration under the PREP Act for medical countermeasures against COVID-19, as amended April 10, 2020 and June 4, 2020, are further amended pursuant to section 319F-3(b)(4) of the PHS Act as described below. All other sections of the Declaration remain in effect as published at 85 FR 15198 (Mar. 17, 2020) and amended at 85 FR 21012 (Apr.

15, 2020) and 85 FR 35100 (June 8, 2020). 1. Covered Persons, section V, delete in full and replace with. V.

Covered Persons 42 U.S.C. 247d-6d(i)(2), (3), (4), (6), (8)(A) and (B) Covered Persons who are afforded liability immunity under this Declaration are “manufacturers,” “distributors,” “program planners,” “qualified persons,” and their officials, agents, and employees, as those terms are defined in the PREP Act, and the United States. In addition, I have determined that the following additional persons are qualified persons. (a) Any person authorized in accordance with the public health and medical emergency response of the Authority Having Jurisdiction, as described in Section VII below, to prescribe, administer, deliver, distribute or dispense the Covered Countermeasures, and their officials, agents, employees, contractors and volunteers, following a Declaration of an emergency.

(b) any person authorized to prescribe, administer, or dispense the Covered Countermeasures or who is otherwise authorized to perform an activity under an Emergency Use Authorization in accordance with Section 564 of the FD&C Act. (c) any person authorized to prescribe, administer, or dispense Covered Countermeasures in accordance with Section 564A of the FD&C Act. And (d) a State-licensed pharmacist who orders and administers, and pharmacy interns who administer (if the pharmacy intern acts under the supervision of such pharmacist and the pharmacy intern is licensed or registered by his or her State board of pharmacy), vaccines that the Advisory Committee on Immunization Practices (ACIP) recommends to persons ages three through 18 according to ACIP's standard immunization schedule. Such State-licensed pharmacists and the State-licensed or registered interns under their supervision are qualified persons only if the following requirements are met.

The vaccine must be FDA-authorized or FDA-approved. The vaccination must be ordered and administered according to ACIP's standard immunization schedule. The licensed pharmacist must complete a practical training program of at least 20 hours that is approved by the Accreditation Council for Pharmacy Education (ACPE). This training program must include hands-on injection technique, clinical evaluation of indications and contraindications of vaccines, and the recognition and treatment of emergency reactions to vaccines.

The licensed or registered pharmacy intern must complete a practical training program that is approved by the ACPE. This training program must include hands-on injection technique, clinical evaluation of indications and contraindications of vaccines, and the recognition and treatment of emergency reactions to vaccines. The licensed pharmacist and licensed or registered pharmacy intern must have a current certificate in basic cardiopulmonary resuscitation. The licensed pharmacist must complete a minimum of two hours of ACPE-approved, immunization-related continuing pharmacy education during each State licensing period.

The licensed pharmacist must comply with recordkeeping and reporting requirements of the jurisdiction in which he or she administers vaccines, including informing the patient's primary-care provider when available, submitting the required immunization information to the State or local immunization information system (vaccine registry), complying with requirements with respect to reporting adverse events, and complying with requirements whereby the person administering a vaccine must review the vaccine registry or other vaccination records prior to administering a vaccine. The licensed pharmacist must inform his or her childhood-vaccination patients and the adult caregiver accompanying the child of the importance of a well-child visit with a pediatrician or other licensed primary-care provider and refer patients as appropriate. Nothing in this Declaration shall be construed to affect the National Vaccine Injury Compensation Program, including an injured party's ability to obtain compensation under that program. Covered countermeasures that are subject to the National Vaccine Injury Compensation Program authorized under 42 U.S.C.

300aa-10 et seq. Are covered under this Declaration for the purposes of liability immunity and injury compensation only to the extent that injury compensation is not provided under that Program. All other Start Printed Page 52141terms and conditions of the Declaration apply to such covered countermeasures. 2.

Category of Disease, Health Condition, or Threat, section VIII, delete in full and replace with. VIII. Category of Disease, Health Condition, or Threat 42 U.S.C. 247d-6d(b)(2)(A) The category of disease, health condition, or threat for which I recommend the administration or use of the Covered Countermeasures is not only COVID-19 caused by SARS-CoV-2 or a virus mutating therefrom, but also other diseases, health conditions, or threats that may have been caused by COVID-19, SARS-CoV-2, or a virus mutating therefrom, including the decrease in the rate of childhood immunizations, which will lead to an increase in the rate of infectious diseases.

Start Authority 42 U.S.C. 247d-6d. End Authority Start Signature Dated. August 19, 2020.

Alex M. Azar II, Secretary of Health and Human Services. End Signature End Supplemental Information [FR Doc. 2020-18542 Filed 8-20-20.

Start Preamble Centers benicar online pharmacy for Medicare &. Medicaid Services (CMS), HHS. Extension of benicar online pharmacy timeline for publication of final rule. This notice announces an extension of the timeline for publication of a Medicare final rule in accordance with the Social Security Act, which allows us to extend the timeline for publication of the final rule. As of August 26, benicar online pharmacy 2020, the timeline for publication of the final rule to finalize the provisions of the October 17, 2019 proposed rule (84 FR 55766) is extended until August 31, 2021.

Start Further Info Lisa O. Wilson, (410) 786-8852. End Further Info End Preamble Start Supplemental Information In the October 17, 2019 Federal Register (84 FR 55766), we published a benicar online pharmacy proposed rule that addressed undue regulatory impact and burden of the physician self-referral law. The proposed rule was issued in conjunction with the Centers for Medicare &. Medicaid Services' (CMS) Patients over Paperwork initiative and the Department of Health and Human benicar online pharmacy Services' (the Department or HHS) Regulatory Sprint to Coordinated Care.

In the proposed rule, we proposed exceptions to the physician self-referral law for certain value-based compensation arrangements between or among physicians, providers, and suppliers. A new exception for certain arrangements under which a physician receives limited remuneration for items or services actually provided by the physician. A new exception for donations of cybersecurity technology and related benicar online pharmacy services. And amendments to the existing exception for electronic health records (EHR) items and services. The proposed rule also provides critically necessary guidance for physicians and health care providers and suppliers whose financial relationships are governed by the physician self-referral statute and benicar online pharmacy regulations.

This notice announces an extension of the timeline for publication of the final rule and the continuation of effectiveness of the proposed rule. Section 1871(a)(3)(A) of the Social Security Act (the Act) requires us to establish and publish a regular timeline for the publication of final regulations based on the previous publication of a proposed regulation. In accordance with section 1871(a)(3)(B) of the Act, the timeline benicar online pharmacy may vary among different regulations based on differences in the complexity of the regulation, the number and scope of comments received, and other relevant factors, but may not be longer than 3 years except under exceptional circumstances. In addition, in accordance with section 1871(a)(3)(B) of the Act, the Secretary may extend the initial targeted publication date of the final regulation if the Secretary, no later than the regulation's previously established proposed publication date, publishes a notice with the new target date, and such notice includes a brief explanation of the justification for the variation. We announced in the Spring 2020 Unified Agenda (June 30, 2020, benicar online pharmacy www.reginfo.gov) that we would issue the final rule in August 2020.

However, we are still working through the Start Printed Page 52941complexity of the issues raised by comments received on the proposed rule and therefore we are not able to meet the announced publication target date. This notice benicar online pharmacy extends the timeline for publication of the final rule until August 31, 2021. Start Signature Dated. August 24, 2020. Wilma M benicar online pharmacy.

Robinson, Deputy Executive Secretary to the Department, Department of Health and Human Services. End Signature End Supplemental benicar online pharmacy Information [FR Doc. 2020-18867 Filed 8-26-20. 8:45 am]BILLING CODE 4120-01-PStart Preamble Notice of amendment. The Secretary issues this amendment pursuant benicar online pharmacy to section 319F-3 of the Public Health Service Act to add additional categories of Qualified Persons and amend the category of disease, health condition, or threat for which he recommends the administration or use of the Covered Countermeasures.

This amendment to the Declaration published on March 17, 2020 (85 FR 15198) is effective as of August 24, 2020. Start Further benicar online pharmacy Info Robert P. Kadlec, MD, MTM&H, MS, Assistant Secretary for Preparedness and Response, Office of the Secretary, Department of Health and Human Services, 200 Independence Avenue SW, Washington, DC 20201. Telephone. 202-205-2882.

End Further Info End Preamble Start Supplemental Information The Public Readiness and Emergency Preparedness Act (PREP Act) authorizes the Secretary of Health and Human Services (the Secretary) to issue a Declaration to provide liability immunity to certain individuals and entities (Covered Persons) against any claim of loss caused by, arising out of, relating to, or resulting from the manufacture, distribution, administration, or use of medical countermeasures (Covered Countermeasures), except for claims involving “willful misconduct” as defined in the PREP Act. Under the PREP Act, a Declaration may be amended as circumstances warrant. The PREP Act was enacted on December 30, 2005, as Public Law 109-148, Division C, § 2. It amended the Public Health Service (PHS) Act, adding section 319F-3, which addresses liability immunity, and section 319F-4, which creates a compensation program. These sections are codified at 42 U.S.C.

247d-6d and 42 U.S.C. 247d-6e, respectively. Section 319F-3 of the PHS Act has been amended by the Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA), Public Law 113-5, enacted on March 13, 2013 and the Coronavirus Aid, Relief, and Economic Security (CARES) Act, Public Law 116-136, enacted on March 27, Start Printed Page 521372020, to expand Covered Countermeasures under the PREP Act. On January 31, 2020, the Secretary declared a public health emergency pursuant to section 319 of the PHS Act, 42 U.S.C. 247d, effective January 27, 2020, for the entire United States to aid in the response of the nation's health care community to the COVID-19 outbreak.

Pursuant to section 319 of the PHS Act, the Secretary renewed that declaration on April 26, 2020, and July 25, 2020. On March 10, 2020, the Secretary issued a Declaration under the PREP Act for medical countermeasures against COVID-19 (85 FR 15198, Mar. 17, 2020) (the Declaration). On April 10, the Secretary amended the Declaration under the PREP Act to extend liability immunity to covered countermeasures authorized under the CARES Act (85 FR 21012, Apr. 15, 2020).

On June 4, the Secretary amended the Declaration to clarify that covered countermeasures under the Declaration include qualified countermeasures that limit the harm COVID-19 might otherwise cause. The Secretary now amends section V of the Declaration to identify as qualified persons covered under the PREP Act, and thus authorizes, certain State-licensed pharmacists to order and administer, and pharmacy interns (who are licensed or registered by their State board of pharmacy and acting under the supervision of a State-licensed pharmacist) to administer, any vaccine that the Advisory Committee on Immunization Practices (ACIP) recommends to persons ages three through 18 according to ACIP's standard immunization schedule (ACIP-recommended vaccines).[] The Secretary also amends section VIII of the Declaration to clarify that the category of disease, health condition, or threat for which he recommends the administration or use of the Covered Countermeasures includes not only COVID-19 caused by SARS-CoV-2 or a virus mutating therefrom, but also other diseases, health conditions, or threats that may have been caused by COVID-19, SARS-CoV-2, or a virus mutating therefrom, including the decrease in the rate of childhood immunizations, which will lead to an increase in the rate of infectious diseases. Description of This Amendment by Section Section V. Covered Persons Under the PREP Act and the Declaration, a “qualified person” is a “covered person.” Subject to certain limitations, a covered person is immune from suit and liability under Federal and State law with respect to all claims for loss caused by, arising out of, relating to, or resulting from the administration or use of a covered countermeasure if a declaration under subsection (b) has been issued with respect to such countermeasure. €œQualified person” includes (A) a licensed health professional or other individual who is authorized to prescribe, administer, or dispense such countermeasures under the law of the State in which the countermeasure was prescribed, administered, or dispensed.

Or (B) “a person within a category of persons so identified in a declaration by the Secretary” under subsection (b) of the PREP Act. 42 U.S.C. 247d-6d(i)(8).[] By this amendment to the Declaration, the Secretary identifies an additional category of persons who are qualified persons under section 247d-6d(i)(8)(B).[] On May 8, 2020, CDC reported, “The identified declines in routine pediatric vaccine ordering and doses administered might indicate that U.S. Children and their communities face increased risks for outbreaks of vaccine-preventable diseases,” and suggested that a decrease in rates of routine childhood vaccinations were due to changes in healthcare access, social distancing, and other COVID-19 mitigation strategies.[] The report also stated that “[p]arental concerns about potentially exposing their children to COVID-19 during well child visits might contribute to the declines observed.” [] On July 10, 2020, CDC reported its findings of a May survey it conducted to assess the capacity of pediatric health care practices to provide immunization services to children during the COVID-19 pandemic. The survey, which was limited to practices participating in the Vaccines for Children program, found that, as of mid-May, 15 percent of Northeast pediatric practices were closed, 12.5 percent of Midwest practices were closed, 6.2 percent of practices in the South were closed, and 10 percent of practices in the West were closed.

Most practices had reduced office hours for in-person visits. When asked whether their practices would likely be able to accommodate new patients for immunization services through August, 418 practices (21.3 percent) either responded that this was not likely or the practice was permanently closed or not resuming immunization services for all patients, and 380 (19.6 percent) responded that they were unsure. Urban practices and those in the Northeast were less likely to be able to accommodate new patients compared with rural practices and those in the South, Midwest, or West.[] In response to these troubling developments, CDC and the American Academy of Pediatrics have stressed, “Well-child visits and vaccinations are essential services and help make sure children are protected.” [] The Secretary re-emphasizes that important recommendation to parents and legal guardians here. If your child is due for a well-child visit, contact your pediatrician's or other primary-care provider's office and ask about ways that the office safely offers well-child visits and vaccinations. Many medical offices are taking extra steps to make sure that well-child visits can occur safely during the COVID-19 pandemic, including.

Scheduling sick visits and well-child visits during different times of the Start Printed Page 52138day or days of the week, or at different locations. Asking patients to remain outside until it is time for their appointments to reduce the number of people in waiting rooms. Adhering to recommended social (physical) distancing and other infection-control practices, such as the use of masks. The decrease in childhood-vaccination rates is a public health threat and a collateral harm caused by COVID-19. Together, the United States must turn to available medical professionals to limit the harm and public health threats that may result from decreased immunization rates.

We must quickly do so to avoid preventable infections in children, additional strains on our healthcare system, and any further increase in avoidable adverse health consequences—particularly if such complications coincide with additional resurgence of COVID-19. Together with pediatricians and other healthcare professionals, pharmacists are positioned to expand access to childhood vaccinations. Many States already allow pharmacists to administer vaccines to children of any age.[] Other States permit pharmacists to administer vaccines to children depending on the age—for example, 2, 3, 5, 6, 7, 9, 10, 11, or 12 years of age and older.[] Few States restrict pharmacist-administered vaccinations to only adults.[] Many States also allow properly trained individuals under the supervision of a trained pharmacist to administer those vaccines.[] Pharmacists are well positioned to increase access to vaccinations, particularly in certain areas or for certain populations that have too few pediatricians and other primary-care providers, or that are otherwise medically underserved.[] As of 2018, nearly 90 percent of Americans lived within five miles of a community pharmacy.[] Pharmacies often offer extended hours and added convenience. What is more, pharmacists are trusted healthcare professionals with established relationships with their patients. Pharmacists also have strong relationships with local medical providers and hospitals to refer patients as appropriate.

For example, pharmacists already play a significant role in annual influenza vaccination. In the early 2018-19 season, they administered the influenza vaccine to nearly a third of all adults who received the vaccine.[] Given the potential danger of serious influenza and continuing COVID-19 outbreaks this autumn and the impact that such concurrent outbreaks may have on our population, our healthcare system, and our whole-of-nation response to the COVID-19 pandemic, we must quickly expand access to influenza vaccinations. Allowing more qualified pharmacists to administer the influenza vaccine to children will make vaccinations more accessible. Therefore, the Secretary amends the Declaration to identify State-licensed pharmacists (and pharmacy interns acting under their supervision if the pharmacy intern is licensed or registered by his or her State board of pharmacy) as qualified persons under section 247d-6d(i)(8)(B) when the pharmacist orders and either the pharmacist or the supervised pharmacy intern administers vaccines to individuals ages three through 18 pursuant to the following requirements. The vaccine must be FDA-authorized or FDA-approved.

The vaccination must be ordered and administered according to ACIP's standard immunization schedule.[] The licensed pharmacist must complete a practical training program of at least 20 hours that is approved by the Accreditation Council for Pharmacy Education (ACPE). This training Start Printed Page 52139program must include hands-on injection technique, clinical evaluation of indications and contraindications of vaccines, and the recognition and treatment of emergency reactions to vaccines.[] The licensed or registered pharmacy intern must complete a practical training program that is approved by the ACPE. This training program must include hands-on injection technique, clinical evaluation of indications and contraindications of vaccines, and the recognition and treatment of emergency reactions to vaccines.[] The licensed pharmacist and licensed or registered pharmacy intern must have a current certificate in basic cardiopulmonary resuscitation.[] The licensed pharmacist must complete a minimum of two hours of ACPE-approved, immunization-related continuing pharmacy education during each State licensing period.[] The licensed pharmacist must comply with recordkeeping and reporting requirements of the jurisdiction in which he or she administers vaccines, including informing the patient's primary-care provider when available, submitting the required immunization information to the State or local immunization information system (vaccine registry), complying with requirements with respect to reporting adverse events, and complying with requirements whereby the person administering a vaccine must review the vaccine registry or other vaccination records prior to administering a vaccine.[] The licensed pharmacist must inform his or her childhood-vaccination patients and the adult caregivers accompanying the children of the importance of a well-child visit with a pediatrician or other licensed primary-care provider and refer patients as appropriate.[] These requirements are consistent with those in many States that permit licensed pharmacists to order and administer vaccines to children and permit licensed or registered pharmacy interns acting under their supervision to administer vaccines to children.[] Administering vaccinations to children age three and older is less complicated and requires less training and resources than administering vaccinations to younger children. That is because ACIP generally recommends administering intramuscular injections in the deltoid muscle for individuals age three and older.[] For individuals less than three years of age, ACIP generally recommends administering intramuscular injections in the anterolateral aspect of the thigh muscle.[] Administering injections in the thigh muscle often presents additional complexities and requires additional training and resources including additional personnel to safely position the child while another healthcare professional injects the vaccine.[] Moreover, as of 2018, 40% of three-year-olds were enrolled in preprimary programs (i.e. Preschool or kindergarten programs).[] Preprimary programs are beginning in the coming weeks or months, so the Secretary has concluded that it is particularly important for individuals ages three through 18 to receive ACIP-recommended vaccines according to ACIP's standard immunization schedule.

All States require children to be vaccinated against certain communicable diseases as a condition of school attendance. These laws often apply to both public and private schools with identical immunization and exemption provisions.[] As nurseries, preschools, kindergartens, and schools reopen, increased access to childhood vaccinations is essential to ensuring children can return. Notwithstanding any State or local scope-of-practice legal requirements, (1) qualified licensed pharmacists are identified as qualified persons to order and administer ACIP-recommended vaccines and (2) qualified State-licensed or registered pharmacy interns are identified as qualified persons to administer the ACIP-recommended vaccines ordered by their supervising qualified licensed pharmacist.[] Both the PREP Act and the June 4, 2020 Second Amendment to the Declaration define “covered countermeasures” to include qualified pandemic and epidemic products that “limit the harm such pandemic or epidemic might otherwise cause.” [] The troubling decrease in ACIP-recommended childhood vaccinations and the resulting increased risk of associated diseases, adverse health conditions, and other threats are categories of harms otherwise caused by Start Printed Page 52140COVID-19 as set forth in Sections VI and VIII of this Declaration.[] Hence, such vaccinations are “covered countermeasures” under the PREP Act and the June 4, 2020 Second Amendment to the Declaration. Nothing in this Declaration shall be construed to affect the National Vaccine Injury Compensation Program, including an injured party's ability to obtain compensation under that program. Covered countermeasures that are subject to the National Vaccine Injury Compensation Program authorized under 42 U.S.C.

300aa-10 et seq. Are covered under this Declaration for the purposes of liability immunity and injury compensation only to the extent that injury compensation is not provided under that Program. All other terms and conditions of the Declaration apply to such covered countermeasures. Section VIII. Category of Disease, Health Condition, or Threat As discussed, the troubling decrease in ACIP-recommended childhood vaccinations and the resulting increased risk of associated diseases, adverse health conditions, and other threats are categories of harms otherwise caused by COVID-19.

The Secretary therefore amends section VIII, which describes the category of disease, health condition, or threat for which he recommends the administration or use of the Covered Countermeasures, to clarify that the category of disease, health condition, or threat for which he recommends the administration or use of the Covered Countermeasures is not only COVID-19 caused by SARS-CoV-2 or a virus mutating therefrom, but also other diseases, health conditions, or threats that may have been caused by COVID-19, SARS-CoV-2, or a virus mutating therefrom, including the decrease in the rate of childhood immunizations, which will lead to an increase in the rate of infectious diseases. Amendments to Declaration Amended Declaration for Public Readiness and Emergency Preparedness Act Coverage for medical countermeasures against COVID-19. Sections V and VIII of the March 10, 2020 Declaration under the PREP Act for medical countermeasures against COVID-19, as amended April 10, 2020 and June 4, 2020, are further amended pursuant to section 319F-3(b)(4) of the PHS Act as described below. All other sections of the Declaration remain in effect as published at 85 FR 15198 (Mar. 17, 2020) and amended at 85 FR 21012 (Apr.

15, 2020) and 85 FR 35100 (June 8, 2020). 1. Covered Persons, section V, delete in full and replace with. V. Covered Persons 42 U.S.C.

247d-6d(i)(2), (3), (4), (6), (8)(A) and (B) Covered Persons who are afforded liability immunity under this Declaration are “manufacturers,” “distributors,” “program planners,” “qualified persons,” and their officials, agents, and employees, as those terms are defined in the PREP Act, and the United States. In addition, I have determined that the following additional persons are qualified persons. (a) Any person authorized in accordance with the public health and medical emergency response of the Authority Having Jurisdiction, as described in Section VII below, to prescribe, administer, deliver, distribute or dispense the Covered Countermeasures, and their officials, agents, employees, contractors and volunteers, following a Declaration of an emergency. (b) any person authorized to prescribe, administer, or dispense the Covered Countermeasures or who is otherwise authorized to perform an activity under an Emergency Use Authorization in accordance with Section 564 of the FD&C Act. (c) any person authorized to prescribe, administer, or dispense Covered Countermeasures in accordance with Section 564A of the FD&C Act.

And (d) a State-licensed pharmacist who orders and administers, and pharmacy interns who administer (if the pharmacy intern acts under the supervision of such pharmacist and the pharmacy intern is licensed or registered by his or her State board of pharmacy), vaccines that the Advisory Committee on Immunization Practices (ACIP) recommends to persons ages three through 18 according to ACIP's standard immunization schedule. Such State-licensed pharmacists and the State-licensed or registered interns under their supervision are qualified persons only if the following requirements are met. The vaccine must be FDA-authorized or FDA-approved. The vaccination must be ordered and administered according to ACIP's standard immunization schedule. The licensed pharmacist must complete a practical training program of at least 20 hours that is approved by the Accreditation Council for Pharmacy Education (ACPE).

This training program must include hands-on injection technique, clinical evaluation of indications and contraindications of vaccines, and the recognition and treatment of emergency reactions to vaccines. The licensed or registered pharmacy intern must complete a practical training program that is approved by the ACPE. This training program must include hands-on injection technique, clinical evaluation of indications and contraindications of vaccines, and the recognition and treatment of emergency reactions to vaccines. The licensed pharmacist and licensed or registered pharmacy intern must have a current certificate in basic cardiopulmonary resuscitation. The licensed pharmacist must complete a minimum of two hours of ACPE-approved, immunization-related continuing pharmacy education during each State licensing period.

The licensed pharmacist must comply with recordkeeping and reporting requirements of the jurisdiction in which he or she administers vaccines, including informing the patient's primary-care provider when available, submitting the required immunization information to the State or local immunization information system (vaccine registry), complying with requirements with respect to reporting adverse events, and complying with requirements whereby the person administering a vaccine must review the vaccine registry or other vaccination records prior to administering a vaccine. The licensed pharmacist must inform his or her childhood-vaccination patients and the adult caregiver accompanying the child of the importance of a well-child visit with a pediatrician or other licensed primary-care provider and refer patients as appropriate. Nothing in this Declaration shall be construed to affect the National Vaccine Injury Compensation Program, including an injured party's ability to obtain compensation under that program. Covered countermeasures that are subject to the National Vaccine Injury Compensation Program authorized under 42 U.S.C. 300aa-10 et seq.

Are covered under this Declaration for the purposes of liability immunity and injury compensation only to the extent that injury compensation is not provided under that Program. All other Start Printed Page 52141terms and conditions of the Declaration apply to such covered countermeasures. 2. Category of Disease, Health Condition, or Threat, section VIII, delete in full and replace with. VIII.

Category of Disease, Health Condition, or Threat 42 U.S.C. 247d-6d(b)(2)(A) The category of disease, health condition, or threat for which I recommend the administration or use of the Covered Countermeasures is not only COVID-19 caused by SARS-CoV-2 or a virus mutating therefrom, but also other diseases, health conditions, or threats that may have been caused by COVID-19, SARS-CoV-2, or a virus mutating therefrom, including the decrease in the rate of childhood immunizations, which will lead to an increase in the rate of infectious diseases. Start Authority 42 U.S.C. 247d-6d. End Authority Start Signature Dated.

August 19, 2020. Alex M. Azar II, Secretary of Health and Human Services. End Signature End Supplemental Information [FR Doc. 2020-18542 Filed 8-20-20.

What may interact with Benicar?

  • blood pressure medications
  • hawthorn
  • lithium
  • monoamine oxidase inhibitors
  • potassium supplements
  • water pills (diuretics)

Tell your prescriber or health care professional about all other medicines you are taking, including nonprescription medicines, nutritional supplements, or herbal products. Also tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works. Check with your health care professional before stopping or starting any of your medicines.

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Shutterstock benicar hct generic cost The U.S. Department of Health and Human Services State Opioid Response (SOR) recently awarded the state of Ohio $96.2 million.The program provides community support, psychosocial services, and access to lifesaving, evidence-based medication to treat opioid-use disorders benicar hct generic cost. The state will use the funding to continue and expand its current programs.“While our country works to combat the COVID-19 pandemic, we cannot lose sight of the opioid epidemic that continues to also take the lives of too many in our state,” U.S. Rep. Tim Ryan (D-OH), said.

€œFor those who struggle with substance use disorders and mental illness, COVID-19 has worsened existing conditions and created new struggles across our state and nation. For us to fight back, we need sufficient resources to address the root causes of the opioid epidemic. I’m proud to have used my position on the House Appropriations Committee to ensure Northeast Ohio – and so many other communities across Ohio – get the funding we need. This sizable grant is a big step towards ensuring communities like ours will not only be able to help those who are suffering but for us to put an end to this tragic opioid epidemic once and for all.”This is the first round of SOR funding.Shutterstock The U.S. Department of Labor recently awarded the Maryland Department of Labor $4.6 million in funding to participate in the Support to Communities.

Fostering Opioid Recovery through Workforce Development pilot program.The program will provide job training and other services in communities significantly affected by the opioid crisis. Maryland is one of four states participating.“Our department is very thankful to receive this funding from the U.S. Department of Labor, so we can continue to help Marylanders acquire the skills, tools, and support they need to overcome workforce challenges related to opioid and substance abuse,” Tiffany Robinson, Maryland Department of Labor secretary, said. €œThis funding could not have come at a more critical time and will give those impacted by the opioid epidemic hope for a better tomorrow.”The department will divide funding between seven Local Workforce Areas, representing 14 jurisdictions that have experienced negative social and economic impacts resulting from the opioid crisis.The 14 jurisdictions are the city of Baltimore and counties of Allegany, Anne Arundel, Baltimore, Caroline, Cecil, Dorchester, Frederick, Garrett, Harford, Kent, Talbot, Queen Anne’s, and Washington.The state expects more than 700 people will participate in the program. Participants will receive recovery services and job training..

Shutterstock The U.S benicar online pharmacy. Department of Health and Human Services State Opioid Response (SOR) recently awarded the state of Ohio $96.2 million.The program provides community support, psychosocial services, and benicar online pharmacy access to lifesaving, evidence-based medication to treat opioid-use disorders. The state will use the funding to continue and expand its current programs.“While our country works to combat the COVID-19 pandemic, we cannot lose sight of the opioid epidemic that continues to also take the lives of too many in our state,” U.S. Rep.

Tim Ryan (D-OH), said. €œFor those who struggle with substance use disorders and mental illness, COVID-19 has worsened existing conditions and created new struggles across our state and nation. For us to fight back, we need sufficient resources to address the root causes of the opioid epidemic. I’m proud to have used my position on the House Appropriations Committee to ensure Northeast Ohio – and so many other communities across Ohio – get the funding we need.

This sizable grant is a big step towards ensuring communities like ours will not only be able to help those who are suffering but for us to put an end to this tragic opioid epidemic once and for all.”This is the first round of SOR funding.Shutterstock The U.S. Department of Labor recently awarded the Maryland Department of Labor $4.6 million in funding to participate in the Support to Communities. Fostering Opioid Recovery through Workforce Development pilot program.The program will provide job training and other services in communities significantly affected by the opioid crisis. Maryland is one of four states participating.“Our department is very thankful to receive this funding from the U.S.

Department of Labor, so we can continue to help Marylanders acquire the skills, tools, and support they need to overcome workforce challenges related to opioid and substance abuse,” Tiffany Robinson, Maryland Department of Labor secretary, said. €œThis funding could not have come at a more critical time and will give those impacted by the opioid epidemic hope for a better tomorrow.”The department will divide funding between seven Local Workforce Areas, representing 14 jurisdictions that have experienced negative social and economic impacts resulting from the opioid crisis.The 14 jurisdictions are the city of Baltimore and counties of Allegany, Anne Arundel, Baltimore, Caroline, Cecil, Dorchester, Frederick, Garrett, Harford, Kent, Talbot, Queen Anne’s, and Washington.The state expects more than 700 people will participate in the program. Participants will receive recovery services and job training..

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A Westchester man is facing charges for allegedly exposing himself to a pair of women and attempting to sexually assault one, the District Attorney’s Office announced.Yonkers resident Folarin Soulaude was indicted for burglary and sexual assault charges following incidents in a Nepperhan Avenue apartment building over the summer when he gained access to one residence posing as a handyman.Specifically, Soulaude, 37, was charged with:Burglary as a sexually motivated felony;Burglary;Sexual abuse;Public lewdness.It is alleged that shortly before Wednesday, June 24, Soulaude knocked on doors in the Nepperhan Avenue apartment building in an benicar other names attempt to gain entry into homes.Westchester County District Attorney Anthony Scarpino, Jr. Said that one woman allowed him benicar other names into her apartment, believing he was there to fix a pipe. Instead, Soulaude allegedly dropped his pants and exposed himself to the woman upon entering the home.Scarpino said that the woman screamed and fled into the hallway, with Soulaude chasing her, attacking her, and pinning her against a wall, at which point he attempted to take off her pants. Another resident intervened benicar other names and Soulaude proceeded to flee into the building’s parking garage. It is further alleged that after fleeing into the parking garage, Soulaude proceeded to expose himself to a woman who was parking her car, who called the police.

Officers then apprehended Soulaude without benicar other names further incident.Soulaude was arraigned this week and a temporary order of protection was issued for his victims. He is scheduled to appear back in court on Tuesday, Jan. 12, 2021 benicar other names. Click here to sign up for Daily Voice's free daily emails and news alerts..

A Westchester man is benicar online pharmacy facing charges for allegedly exposing himself to a pair of women and attempting to sexually assault one, the District Attorney’s Office announced.Yonkers resident Folarin Soulaude was indicted for burglary and sexual assault charges following incidents in a Nepperhan Avenue apartment building over the summer when he gained access to one residence posing as a handyman.Specifically, Soulaude, 37, was charged with:Burglary as a sexually motivated felony;Burglary;Sexual abuse;Public lewdness.It is alleged that shortly before Wednesday, June 24, Soulaude knocked on doors in the Nepperhan Avenue apartment building in an attempt to gain entry into homes.Westchester County District Attorney Anthony Scarpino, Jr. Said that one woman allowed him benicar online pharmacy into her apartment, believing he was there to fix a pipe. Instead, Soulaude allegedly dropped his pants and exposed himself to the woman upon entering the home.Scarpino said that the woman screamed and fled into the hallway, with Soulaude chasing her, attacking her, and pinning her against a wall, at which point he attempted to take off her pants. Another resident intervened and Soulaude proceeded to flee benicar online pharmacy into the building’s parking garage. It is further alleged that after fleeing into the parking garage, Soulaude proceeded to expose himself to a woman who was parking her car, who called the police.

Officers then apprehended Soulaude without further incident.Soulaude was benicar online pharmacy arraigned this week and a temporary order of protection was issued for his victims. He is scheduled to appear back in court on Tuesday, Jan. 12, 2021 benicar online pharmacy. Click here to sign up for Daily Voice's free daily emails and news alerts..

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€‚For the podcast associated with this article, please visit https://academic.oup.com/eurheartj/pages/Podcasts.This Focus Issue on heart failure (HF) provides novel clinically relevant information on sodium–glucose co-transporter-2 (SGLT2) inhibitors which, initially proposed for the treatment of type 2 diabetes mellitus (T2D), have been found to improve the outcome of HF with reduced ejection fraction (HFrEF) when administered on the top of drugs known to improve the outcome of HF and are recommended in current European Guidelines.1,2Acording to modelling estimates, when compared with no neurohormonal blockade, the use of a broad-based combination of disease-modifying drugs at how to get prescribed benicar target doses in patients with HF may reduce the risk of death by as much as 75%. It is surprising that in spite of this powerful therapeutic armamentarium, <1% of patients with chronic HF are currently receiving recommended drugs at doses that have been shown to prolong life.3 The issue opens with a Current Opinion article entitled ‘Totality of evidence in trials of sodium–glucose co-transporter-2 inhibitors in the patients with heart failure with reduced ejection fraction. Implications for clinical practice’ how to get prescribed benicar by Milton Packer from the Baylor University Medical Center at Dallas in Texas, USA and colleagues. The authors provide a perspective on the totality of evidence with SGLT2 inhibitors in patients with HFrEF.4 This paper is the first to issue a call for a major change in clinical practice based on the concordant results of DAPA-HF and EMPEROR-Reduced trials. The analyses and interpretations that are presented in this manuscript will undoubtedly generate considerable discussion and debate for a long time.Concern about hypotension often leads to withholding of beneficial therapy in patients with HFrEF.

In a clinical research manuscript entitled ‘Effect of dapagliflozin according to baseline how to get prescribed benicar systolic blood pressure in the Dapagliflozin and Prevention of Adverse Outcomes in Heart Failure trial (DAPA-HF)’ John McMurray from the Western Infirmary in Glasgow, UK and colleagues on behalf of the DAPA-HF Investigators and Committees evaluated the efficacy and safety of dapagliflozin according to baseline systolic blood pressure (SBP) in DAPA-HF trial.5 Key inclusion criteria were. New York Heart Association (NYHA) class II–IV, left ventricular ejection fraction (LVEF) ≤40%, elevated N-terminal probrain natriuretic peptide (NT-proBNP) level, and SBP ≥95 mmHg. The primary outcome was a composite of worsening HF or cardiovascular death. The efficacy and safety of dapagliflozin was examined using SBP as how to get prescribed benicar both a categorical and a continuous variable. The placebo-corrected reduction in SBP from baseline to 2 weeks with dapagliflozin was –2.54 mmHg.

The benefit and safety of dapagliflozin were consistent across the how to get prescribed benicar range of SBP. Study drug discontinuation did not differ between dapagliflozin and placebo across the SBP categories examined.The authors conclude that dapagliflozin had a small effect on SBP in patients with HFrEF and was superior to placebo in improving outcomes, and well tolerated, across the range of SBP included in DAPA-HF. The manuscript is accompanied by an Editorial by Francesco Cosentino from the University Hospital Solna in Stockholm, Sweden who comments that altogether, the results of the current post-hoc analysis demonstrating efficacy and safety of dapagliflozin regardless of SBP values might significantly contribute to foster the implementation of dapagliflozin use in HF clinical practice by dissipating any potential safety concern linked with its hypotensive effects.6In a clinical research article entitled ‘A randomized controlled trial of dapagliflozin on left ventricular hypertrophy in people with type two diabetes. The DAPA-LVH trial’, Chim Lang from the University of how to get prescribed benicar Dundee in the UK and colleagues tested the hypothesis that dapagliflozin may regress left ventricular hypertrophy (LVH) in people with T2D.7 The authors randomly assigned 66 patients with T2D, LVH, and controlled blood pressure to receive dapagliflozin 10 mg once daily or placebo for 12 months. The primary endpoint was change in absolute left ventricular mass (LVM), assessed by cardiac magnetic resonance imaging (MRI).

In the intention-to-treat analysis, dapagliflozin significantly reduced LVM compared with placebo, with an absolute mean change of –2.82 g. Additional sensitivity how to get prescribed benicar analysis adjusting for baseline LVM, baseline blood pressure, weight, and SBP change showed the LVM change to remain statistically significant. Dapagliflozin significantly reduced pre-specified secondary endpoints including ambulatory 24-h SBP, nocturnal SBP, body weight, visceral adipose tissue, subcutaneous adipose tissue, insulin resistance, and high-sensitivity C-reactive protein. Figure 1Column bar charts showing the mean regression of left ventricular mass following dapagliflozin treatment compared to placebo (from Brown AJM, Gandy S, McCrimmon R, Houston JG, Struthers AD, Lang CC. A randomized how to get prescribed benicar controlled trial of dapagliflozin on left ventricular hypertrophy in people with type two diabetes.

The DAPA-LVH trial. See pages how to get prescribed benicar 3421–3432).Figure 1Column bar charts showing the mean regression of left ventricular mass following dapagliflozin treatment compared to placebo (from Brown AJM, Gandy S, McCrimmon R, Houston JG, Struthers AD, Lang CC. A randomized controlled trial of dapagliflozin on left ventricular hypertrophy in people with type two diabetes. The DAPA-LVH trial. See pages 3421–3432).Lang and colleagues conclude how to get prescribed benicar that dapagliflozin treatment significantly reduced LVM in patients with T2D and LVH.

The regression of LVM suggests that dapagliflozin can initiate reverse remodelling and changes in left ventricular structure that may partly contribute to cardioprotective effects of dapagliflozin. This manuscript is accompanied by an Editorial by Francesco Paneni from the University of Zurich in Switzerland and colleagues.8 They note that the above-mentioned effects of SGLT2 inhibitors set the ground for a possible beneficial effect of these drugs in patients with HFpEF, where microvascular dysfunction, cardiomyocyte inflammation, and cardiometabolic alterations take centre stage.While several landmark studies have long established that implantable cardioverter-defibrillator (ICD) therapy improves survival for primary prevention of sudden cardiac death ,9 risk stratification parameters and methods for this purpose are clinically underused. In a clinical research article entitled ‘Clinical effectiveness of primary prevention implantable how to get prescribed benicar cardioverter-defibrillators. Results of the EU-CERT-ICD controlled multicentre cohort study’ Markus Zabel from the Universitätsmedizin Göttingen in Germany and colleagues from the EU-CERT-ICD Study Investigators assessed the current clinical effectiveness of primary prevention by ICD therapy in a prospective investigator-initiated, controlled cohort study, conducted in 44 centres and 15 European countries. The study sought to assess current clinical effectiveness of primary prophylactic how to get prescribed benicar ICD implantation.10 The authors recruited 2327 patients with ischaemic or dilated cardiomyopathy and guideline indications for prophylactic ICD implantation.

The primary endpoint was all-cause mortality. Baseline and follow-up data from 2247 patients were analysable. 1516 patients with first ICD implantation (ICD group) and 731 patients without ICD serving how to get prescribed benicar as controls. Multivariable models and propensity scoring for adjustment were used to compare the two groups for mortality. Adjusted mortality associated with ICD vs.

Control was significantly lower (hazard ratio 0.731) how to get prescribed benicar. Subgroup analyses indicated no ICD benefit in diabetics or in those aged ≥75 years. Figure 2Secondary efficacy endpoints comparing cardiosphere-derived cells and placebo at 6 months. Change in how to get prescribed benicar (A) left ventricular end-diastolic volume. (B) left ventricular end-systolic volume.

And (C) N-terminal pro how to get prescribed benicar b-type natriuretic peptide levels. At 6 months. CDC, cardiosphere-derived cell. LVEDV, left ventricular end-diastolic volume how to get prescribed benicar. LVESV, left ventricular end-systolic volume.

NT-proBNP, N-terminal pro b-type natriuretic peptide (from Makkar RR, Kereiakes DJ, Aguirre F, Kowalchuk G, Chakravarty T, Malliaras K, Francis GS, Povsic TJ, Schatz R, Traverse JH, Pogoda JM, Smith RR, Marbán L, Ascheim DD, Ostovaneh MR, Lima JAC, DeMaria A, Marbán E, Henry TD. Intracoronary ALLogeneic heart STem cells to Achieve myocardial how to get prescribed benicar Regeneration (ALLSTAR). A randomized, placebo-controlled, double-blinded trial. See pages 3451--3458).Figure 2Secondary efficacy endpoints comparing cardiosphere-derived cells and placebo at 6 months. Change in (A) left ventricular end-diastolic volume how to get prescribed benicar.

(B) left ventricular end-systolic volume. And (C) how to get prescribed benicar N-terminal pro b-type natriuretic peptide levels. At 6 months. CDC, cardiosphere-derived cell. LVEDV, left how to get prescribed benicar ventricular end-diastolic volume.

LVESV, left ventricular end-systolic volume. NT-proBNP, N-terminal pro b-type natriuretic peptide (from Makkar RR, Kereiakes DJ, Aguirre F, Kowalchuk G, Chakravarty T, Malliaras K, Francis GS, Povsic TJ, Schatz R, Traverse JH, Pogoda JM, Smith RR, Marbán L, Ascheim DD, Ostovaneh MR, Lima JAC, DeMaria A, Marbán E, Henry TD. Intracoronary ALLogeneic heart STem how to get prescribed benicar cells to Achieve myocardial Regeneration (ALLSTAR). A randomized, placebo-controlled, double-blinded trial. See pages 3451--3458).The authors conclude that in contemporary ischaemic/dilated cardiomyopathy patients (LVEF ≤35%, narrow QRS), primary prophylactic ICD treatment was associated with a substantial reduction in how to get prescribed benicar mortality, although this improvement was not consistent across the whole population.

The manuscript is accompanied by an Editorial by N.A. Mark Estes III from the Heart and Vascular Institute UPMC in Pittsburgh, Pennsylvania, USA.11 The authors note that clinicians should be mindful of available risk stratification models and subgroup analyses from the EU-CERT-ICD and other studies. It follows that the process of shared decision-making should include careful consideration of the patient’s wishes and values, with an individualized assessment of potential benefit and risks of primary prevention of sudden death by ICD implantation.Cardiosphere-derived cells (CDCs) are cardiac progenitor cells which exhibit disease-modifying bioactivity how to get prescribed benicar in various models of cardiomyopathy and in previous clinical studies of acute myocardial infarction (MI), dilated cardiomyopathy, and Duchenne muscular dystrophy.12,13 In a clinical research article entitled ‘Intracoronary ALLogeneic heart STem cells to Achieve myocardial Regeneration (ALLSTAR). A randomized, placebo-controlled, double-blinded trial’, Raj Makkar from the Cedars-Sinai Heart Institute in Los Angeles, California, USA and colleagues assessed the safety and efficacy of intracoronary administration of allogeneic CDCs in the multicentre, randomized, double-blind, placebo-controlled, intracoronary ALLogeneic Heart STem Cells to Achieve Myocardial Regeneration (ALLSTAR) trial.14 The authors enrolled patients 4 weeks to 12 months after MI, with LVEF ≤45% and left ventricular LV scar size ≥15% of LVM by MRI. A pre-specified interim analysis was performed when 6-month MRI data were available.

The trial was subsequently stopped due to the low probability of detecting a significant treatment effect of CDCs based on the how to get prescribed benicar primary endpoint. Patients were randomly allocated in a 2:1 ratio to receive CDCs or placebo in the infarct-related artery by the stop–flow technique. The primary safety endpoint was the occurrence, during 1-month post-intracoronary infusion, of acute myocarditis attributable to allogeneic CDCs, ventricular tachycardia- or ventricular fibrillation-related death, sudden unexpected death, or a major adverse cardiac event (death or hospitalization for HF or non-fatal MI). The primary efficacy endpoint was the relative percentage how to get prescribed benicar change in infarct size at 12 months post-infusion as assessed by contrast-enhanced cardiac MRI. Makkar and colleagues randomly allocated 90 patients to the CDC group and 44 to the placebo group.

The mean baseline LVEF how to get prescribed benicar was 40% and the mean scar size was 22% of the LVM. No primary safety endpoint events occurred. There was no difference in the percentage change from baseline in scar size between CDC and placebo groups at 6 months. Compared with placebo, there were significant reductions in LV end-diastolic volume, LV end-systolic volume, and NT-proBNP how to get prescribed benicar at 6 months in CDC-treated patients.The authors conclude that intracoronary infusion of allogeneic CDCs in patients with post-MI left ventricular dysfunction was safe but did not reduce scar size relative to placebo at 6 months. The manuscript is accompanied by an Editorial by Francisco Fernandez-Aviles from the Hospital General Universitario Gregorio Marañón in Madrid, Spain and colleagues.15 The authors feel that various points need to be better addressed before proceeding again to clinical trials, if we want to move the field of cardiovascular regenerative and reparative medicine forward, for the sake of the cardiovascular health of millions of patients.Treatment of pathological cardiac remodelling and subsequent HF represents an unmet clinical need.

Long non-coding RNAs (lncRNAs) are emerging as crucial molecular orchestrators of disease processes including that of heart diseases.16,17 In a Basic Science article entitled ‘Targeting muscle-enriched long non-coding RNA H19 reverses pathological cardiac hypertrophy’, Thomas Thum from the Hannover Medical School in Germany, and colleagues report on the powerful therapeutic potential of the conserved lncRNA H19 in the treatment of pathological cardiac hypertrophy.18 Pressure overload-induced left ventricular cardiac remodelling revealed an up-regulation of H19 in the early phase, but a strong sustained repression upon reaching the decompensated phase of HF. The translational potential of H19 was highlighted by its repression in a large animal (pig) model of LVH, in diseased human how to get prescribed benicar heart samples, in human stem cell-derived cardiomyocytes, and in human engineered heart tissue in response to afterload enhancement. Pressure overload-induced cardiac hypertrophy in H19 knockout mice was aggravated compared with wild-type mice. In contrast, vector-based, cardiomyocyte-directed gene therapy using murine but also human H19 how to get prescribed benicar strongly attenuated HF even when cardiac hypertrophy was already established. Mechanistically, using microarray, gene set enrichment analyses, and chromatin immunoprecipitation-DNA sequencing, the authors identified a link between H19 and prohypertrophic nuclear factor of activated T cells (NFAT) signalling.

H19 physically interacts with the polycomb repressive complex 2 to suppress H3K27 tri-methylation of the antihypertrophic Tescalcin locus which in turn leads to reduced NFAT expression and activity.Thum and colleagues conclude that H19 is highly conserved and down-regulated in failing hearts from mice, pigs, and humans. H19 gene therapy prevents and reverses experimental pressure how to get prescribed benicar overload-induced HF. H19 acts as an antihypertrophic lncRNA and represents a promising therapeutic target to combat pathological cardiac remodelling. The manuscript is accompanied by an Editorial by Gianluigi Condorelli from the Humanitas University in Rozzano, Italy and colleagues. The authors note that dysregulation of epigenetic mechanisms leading to aberrant loss of cardiomyocyte homeostasis is a critical point to consider in understanding how to get prescribed benicar the onset of cardiovascular pathologies.

Thus exploiting lncRNAs as therapeutic agents in myocardial disease could pave the way for efficaciously combatting one of the greatest healthcare burdens worldwide.19With the advent of omics, an innovative inductive method has provided researchers with possible ways new to monitor health and disease. This approach incorporates data from studies of the genome, transcriptome, proteome, and metabolome to focus on the assessment of a varied range of biomolecules.20 In a clinical review article entitled ‘Omics phenotyping in heart failure. The next frontier’ Antoni Bayes-Genis from the Cardiology Service, Hospital Universitari Germans Trias i Pujol in Badalona, Spain and colleagues provide a state-of-the-art review aiming to provide an up-to-date look at breakthrough omic technologies that are helping to unravel HF disease mechanisms and heterogeneity.21 Genomics, transcriptomics, proteomics, and metabolomics in HF are reviewed in depth how to get prescribed benicar. In addition, there is a thorough, expert discussion regarding the value of omics in identifying novel disease pathways, advancing understanding of disease mechanisms, differentiating HF phenotypes, yielding biomarkers for diagnosis or prognosis, or identifying new therapeutic targets in HF. The combination of multiple omics technologies may create a more comprehensive how to get prescribed benicar picture of the factors and pathophysiology involved in HF than achieved by either one alone, and provides a rich resource for predictive phenotype modelling.

However, the successful translation of omics tools as solutions to clinical HF requires that the observations are robust and reproducible, and can be validated across multiple independent populations to ensure confidence in clinical decision-making.This issue is also complemented by a Discussion Forum contribution. In a contribution entitled ‘Heart failure development in obesity. Mechanistic pathways’ Kristjan Karason from the Sahlgrenska University Hospital in Gothenburg, Sweden and colleagues provide a reply to a recent comment how to get prescribed benicar entitled ‘Incident heart failure risk after bariatric surgery. The role of epicardial fat’.22,23The editors hope that this issue of the European Heart Journal will be of interest to its readers.With thanks to Amelia Meier-Batschelet, Johanna Hugger, and Martin Meyer for help with compilation of this article. References1Docherty KF, Jhund PS, Inzucchi SE, Køber L, Kosiborod MN, Martinez FA, Ponikowski P, DeMets DL, Sabatine MS, Bengtsson O, Sjöstrand M, Langkilde AM, Desai AS, Diez M, Howlett JG, Katova T, Ljungman CEA, O’Meara E, Petrie MC, Schou M, Verma S, Vinh PN, Solomon SD, McMurray JJV.

Effects of how to get prescribed benicar dapagliflozin in DAPA-HF according to background heart failure therapy. Eur Heart J 2020;41:2379–2392.2Ponikowski P, Voors AA,, Anker SD, Bueno H, Cleland JGF, Coats AJS, Falk V, González-Juanatey JR, Harjola VP, Jankowska EA, Jessup M, Linde C, Nihoyannopoulos P, Parissis JT, Pieske B, Riley JP, Rosano GMC, Ruilope LM, Ruschitzka F, Rutten FH, van der Meer P. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. The Task Force for the diagnosis and treatment of acute and chronic how to get prescribed benicar heart failure of the European Society of Cardiology (ESC). Developed with the special contribution of the Heart Failure Association (HFA) of the ESC.

Eur Heart J 2016;37:2129–2200.3Packer M how to get prescribed benicar. Are the benefits of SGLT2 inhibitors in heart failure and a reduced ejection fraction influenced by background therapy?. Expectations and realities of a new standard of care. Eur Heart how to get prescribed benicar J 2020;41:2393–2396.4Butler J, Zannad F, Filippatos G, Anker SD, Packer M. Totality of evidence in trials of sodium–glucose co-transporter-2 inhibitors in the patients with heart failure with reduced ejection fraction.

Implications for clinical practice. Eur Heart how to get prescribed benicar J 2020;41:3398–3401.5Serenelli M, Böhm M, Inzucchi SE, Køber L, Kosiborod MN, Martinez FA, Ponikowski P,, Sabatine MS, Solomon SD, DeMets DL, Bengtsson O, Sjöstrand M, Langkilde AM, Anand IS, Chiang CE, Chopra VK, de Boer RA, Diez M, Dukát A, Ge J, Howlett JG, Katova T, Kitakaze M, Ljungman CEA, Verma S,, Docherty KF, Jhund PS, McMurray JJV. Effect of dapagliflozin according to baseline systolic blood pressure in the Dapagliflozin and Prevention of Adverse Outcomes in Heart Failure trial (DAPA-HF). Eur Heart how to get prescribed benicar J 2020;41:3402–3418.6Savarese G, Cosentino F. The interaction between dapagliflozin and blood pressure in heart failure.

New evidence dissipating concerns. Eur Heart J 2020;41:3419–3420.7Brown AJM, Gandy S, McCrimmon R, Houston JG, Struthers how to get prescribed benicar AD, Lang CC. A randomized controlled trial of dapagliflozin on left ventricular hypertrophy in people with type two diabetes. The DAPA-LVH trial. Eur Heart J 2020;41:3421–3432.8Paneni F, Costantino S, how to get prescribed benicar Hamdani N.

Regression of left ventricular hypertrophy with SGLT2 inhibitors. Eur Heart J 2020;41:3433–3436.9Priori SG, Blomström-Lundqvist C, Mazzanti A, Blom N, Borggrefe M, Camm J, Elliott PM, Fitzsimons D, Hatala R, Hindricks G, Kirchhof P, Kjeldsen K, Kuck KH, Hernandez-Madrid A, Nikolaou N, Norekvål TM, Spaulding C, Van Veldhuisen DJ. 2015 ESC Guidelines for the management of patients with ventricular arrhythmias and the how to get prescribed benicar prevention of sudden cardiac death. The Task Force for the Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death of the European Society of Cardiology (ESC). Endorsed by how to get prescribed benicar.

Association for European Paediatric and Congenital Cardiology (AEPC). Eur Heart J 2015;36:2793–2867.10Zabel M, Willems R, Lubinski A, Bauer A, Brugada J, Conen D, Flevari P, Hasenfuß G, Svetlosak M, Huikuri HV, Malik M, Pavlović N, Schmidt G, Sritharan R, Schlögl S, Szavits-Nossan J, Traykov V, Tuinenburg AE, Willich SN, Harden M, Friede T, Svendsen JH, Sticherling C, Merkely B. Clinical effectiveness of primary prevention implantable how to get prescribed benicar cardioverter-defibrillators. Results of the EU-CERT-ICD controlled multicentre cohort study. Eur Heart J 2020;41:3437–3447.11Estes MNA, Saba S.

Primary prevention of how to get prescribed benicar sudden death with the implantable cardioverter defibrillator. Bridging the evidence gap. Eur Heart J 2020;41:3448–3450.12Aminzadeh MA, Tseliou E, Sun B, Cheng K, Malliaras K, Makkar RR, Marbán E. Therapeutic efficacy of cardiosphere-derived cells in a transgenic mouse model how to get prescribed benicar of non-ischaemic dilated cardiomyopathy. Eur Heart J 2015;36:751–762.13Fadini GP, Mehta A, Dhindsa DS, Bonora BM, Sreejit G, Nagareddy P, Quyyumi AA.

Circulating stem cells how to get prescribed benicar and cardiovascular outcomes. From basic science to the clinic. Eur Heart J 2020. Doi:10.1093/eurheartj/ehz923.14Makkar RR, Kereiakes DJ, Aguirre F, Kowalchuk G, Chakravarty T, Malliaras K, Francis GS, Povsic TJ, Schatz R, Traverse JH, how to get prescribed benicar Pogoda JM, Smith RR, Marbán L, Ascheim DD, Ostovaneh MR, Lima JAC, DeMaria A, Marbán E, Henry TD. Intracoronary ALLogeneic heart STem cells to Achieve myocardial Regeneration (ALLSTAR).

A randomized, placebo-controlled, double-blinded trial. Eur Heart J 2020;41:3451–3458.15Sanz-Ruiz how to get prescribed benicar R, Fernández-Avilés F. Cardiovascular regenerative and reparative medicine. Is myocardial infarction the model? how to get prescribed benicar. Eur Heart J 2020;41:3459–3461.16Ounzain S, Micheletti R, Beckmann T, Schroen B, Alexanian M, Pezzuto I, Crippa S, Nemir M, Sarre A, Johnson R, Dauvillier J, Burdet F, Ibberson M, Guigó R, Xenarios I, Heymans S, Pedrazzini T.

Genome-wide profiling of the cardiac transcriptome after myocardial infarction identifies novel heart-specific long non-coding RNAs. Eur Heart J 2015;36:353–368.17Lüscher how to get prescribed benicar TF. Novel molecular mechanisms of vascular disease. Non-coding RNAs, inflammation, and radiation. Eur Heart how to get prescribed benicar J.

2020;40:2467–2470.18Viereck J, Bührke A, Foinquinos A, Chatterjee S, Kleeberger JA, Xiao K, Janssen-Peters H, Batkai S, Ramanujam D, Kraft T, Cebotari S, Gueler F, Beyer AM, Schmitz J, Bräsen JH, Schmitto JD, Gyöngyösi M, Löser A, Hirt MN, Eschenhagen T, Engelhardt S, Bär C, Thum T. Targeting muscle-enriched long non-coding RNA H19 reverses pathological cardiac hypertrophy. Eur Heart how to get prescribed benicar J 2020;41:3462–3474.19Pagiatakis C, Hall IF, Condorelli G. Long non-coding RNA H19. A new avenue for RNA therapeutics in cardiac how to get prescribed benicar hypertrophy?.

Eur Heart J 2020;41:3475–3476.20Hoogeveen RM, Pereira JPB, Nurmohamed NS, Zampoleri V, Bom MJ, Baragetti A, Boekholdt SM, Knaapen P, Khaw KT, Wareham NJ, Groen AK, Catapano AL, Koenig W, Levin E, Stroes ESG. Improved cardiovascular risk prediction using targeted plasma proteomics in primary prevention. Eur Heart J 2020;ehaa648 how to get prescribed benicar. 21Bayes-Genis A, Liu PP, Lanfear DE, de Boer RA, González A, Thum T, Emdin M, Januzzi JL. Omics phenotyping in heart failure.

The next frontier how to get prescribed benicar. Eur Heart J 2020;41:3477–3484.22Karason K, Jamaly S. Heart failure development in obesity how to get prescribed benicar. Mechanistic pathways. Eur Heart J 2020;41:3485.23van Woerden G, van Veldhuisen SL, Rienstra M.

Incident heart failure how to get prescribed benicar risk after bariatric surgery. The role of epicardial fat. Eur Heart J 2020;41:1775. Published how to get prescribed benicar on behalf of the European Society of Cardiology. All rights reserved.

© The Author(s) 2020. For permissions, how to get prescribed benicar please email. Journals.permissions@oup.com. For the podcast associated with this article, please visit https://academic.oup.com/eurheartj/pages/Podcasts.This Focus Issue on heart failure (HF) provides novel clinically relevant information on sodium–glucose co-transporter-2 (SGLT2) inhibitors which, initially proposed for the treatment of type 2 diabetes mellitus (T2D), have been found to improve the outcome of HF with reduced ejection fraction (HFrEF) when administered on the top of drugs known to improve the outcome of HF and are recommended in current European Guidelines.1,2Acording to modelling estimates, when compared with no neurohormonal blockade, the use of a broad-based combination of disease-modifying drugs at target doses in patients with HF may reduce the risk of death by as much as 75%. It is surprising that in spite of this powerful therapeutic armamentarium, <1% of patients with chronic HF are currently receiving recommended drugs at doses that have been shown to prolong life.3 The issue opens with a Current Opinion article entitled ‘Totality of evidence how to get prescribed benicar in trials of sodium–glucose co-transporter-2 inhibitors in the patients with heart failure with reduced ejection fraction. Implications for clinical practice’ by Milton Packer from the Baylor University Medical Center at Dallas in Texas, USA and colleagues.

The authors provide a perspective on the totality of evidence with SGLT2 inhibitors in patients with HFrEF.4 This paper is the first to issue a call for a major change in clinical practice based on the concordant results of DAPA-HF and EMPEROR-Reduced trials. The analyses and interpretations how to get prescribed benicar that are presented in this manuscript will undoubtedly generate considerable discussion and debate for a long time.Concern about hypotension often leads to withholding of beneficial therapy in patients with HFrEF. In a clinical research manuscript entitled ‘Effect of dapagliflozin according to baseline systolic blood pressure in the Dapagliflozin and Prevention of Adverse Outcomes in Heart Failure trial (DAPA-HF)’ John McMurray from the Western Infirmary in Glasgow, UK and colleagues on behalf of the DAPA-HF Investigators and Committees evaluated the efficacy and safety of dapagliflozin according to baseline systolic blood pressure (SBP) in DAPA-HF trial.5 Key inclusion criteria were. New York Heart Association (NYHA) class II–IV, left ventricular ejection fraction (LVEF) ≤40%, elevated N-terminal probrain natriuretic peptide (NT-proBNP) level, and SBP ≥95 mmHg. The primary outcome how to get prescribed benicar was a composite of worsening HF or cardiovascular death.

The efficacy and safety of dapagliflozin was examined using SBP as both a categorical and a continuous variable. The placebo-corrected reduction in SBP from baseline to 2 weeks with dapagliflozin was –2.54 mmHg. The benefit and safety of dapagliflozin were consistent across the range how to get prescribed benicar of SBP. Study drug discontinuation did not differ between dapagliflozin and placebo across the SBP categories examined.The authors conclude that dapagliflozin had a small effect on SBP in patients with HFrEF and was superior to placebo in improving outcomes, and well tolerated, across the range of SBP included in DAPA-HF. The manuscript is accompanied by an Editorial by Francesco Cosentino from the University Hospital Solna in Stockholm, Sweden who comments that altogether, the results of the current post-hoc analysis demonstrating efficacy and safety of dapagliflozin regardless of SBP values might significantly contribute to foster the implementation of dapagliflozin use in HF clinical practice by dissipating any potential safety concern linked with its hypotensive effects.6In a clinical research article entitled ‘A randomized controlled trial of dapagliflozin on left ventricular hypertrophy how to get prescribed benicar in people with type two diabetes.

The DAPA-LVH trial’, Chim Lang from the University of Dundee in the UK and colleagues tested the hypothesis that dapagliflozin may regress left ventricular hypertrophy (LVH) in people with T2D.7 The authors randomly assigned 66 patients with T2D, LVH, and controlled blood pressure to receive dapagliflozin 10 mg once daily or placebo for 12 months. The primary endpoint was change in absolute left ventricular mass (LVM), assessed by cardiac magnetic resonance imaging (MRI). In the intention-to-treat analysis, dapagliflozin significantly reduced LVM how to get prescribed benicar compared with placebo, with an absolute mean change of –2.82 g. Additional sensitivity analysis adjusting for baseline LVM, baseline blood pressure, weight, and SBP change showed the LVM change to remain statistically significant. Dapagliflozin significantly reduced pre-specified secondary endpoints including ambulatory 24-h SBP, nocturnal SBP, body weight, visceral adipose tissue, subcutaneous adipose tissue, insulin resistance, and high-sensitivity C-reactive protein.

Figure 1Column bar charts showing the mean regression of left ventricular mass following dapagliflozin treatment compared to placebo (from Brown AJM, Gandy S, McCrimmon R, Houston JG, how to get prescribed benicar Struthers AD, Lang CC. A randomized controlled trial of dapagliflozin on left ventricular hypertrophy in people with type two diabetes. The DAPA-LVH how to get prescribed benicar trial. See pages 3421–3432).Figure 1Column bar charts showing the mean regression of left ventricular mass following dapagliflozin treatment compared to placebo (from Brown AJM, Gandy S, McCrimmon R, Houston JG, Struthers AD, Lang CC. A randomized controlled trial of dapagliflozin on left ventricular hypertrophy in people with type two diabetes.

The DAPA-LVH trial how to get prescribed benicar. See pages 3421–3432).Lang and colleagues conclude that dapagliflozin treatment significantly reduced LVM in patients with T2D and LVH. The regression of LVM suggests that dapagliflozin can initiate reverse remodelling and changes in left ventricular structure that may partly contribute to cardioprotective effects of dapagliflozin. This manuscript how to get prescribed benicar is accompanied by an Editorial by Francesco Paneni from the University of Zurich in Switzerland and colleagues.8 They note that the above-mentioned effects of SGLT2 inhibitors set the ground for a possible beneficial effect of these drugs in patients with HFpEF, where microvascular dysfunction, cardiomyocyte inflammation, and cardiometabolic alterations take centre stage.While several landmark studies have long established that implantable cardioverter-defibrillator (ICD) therapy improves survival for primary prevention of sudden cardiac death ,9 risk stratification parameters and methods for this purpose are clinically underused. In a clinical research article entitled ‘Clinical effectiveness of primary prevention implantable cardioverter-defibrillators.

Results of the EU-CERT-ICD controlled multicentre cohort study’ Markus Zabel from the Universitätsmedizin Göttingen in Germany and colleagues from the EU-CERT-ICD Study Investigators assessed the current clinical effectiveness of primary prevention by ICD therapy in a prospective investigator-initiated, controlled cohort study, conducted in 44 centres and 15 European countries. The study sought to assess current clinical effectiveness of how to get prescribed benicar primary prophylactic ICD implantation.10 The authors recruited 2327 patients with ischaemic or dilated cardiomyopathy and guideline indications for prophylactic ICD implantation. The primary endpoint was all-cause mortality. Baseline and follow-up data from how to get prescribed benicar 2247 patients were analysable. 1516 patients with first ICD implantation (ICD group) and 731 patients without ICD serving as controls.

Multivariable models and propensity scoring for adjustment were used to compare the two groups for mortality. Adjusted mortality associated with ICD how to get prescribed benicar vs. Control was significantly lower (hazard ratio 0.731). Subgroup analyses indicated no ICD benefit in diabetics or in those aged ≥75 years. Figure 2Secondary efficacy how to get prescribed benicar endpoints comparing cardiosphere-derived cells and placebo at 6 months.

Change in (A) left ventricular end-diastolic volume. (B) left how to get prescribed benicar ventricular end-systolic volume. And (C) N-terminal pro b-type natriuretic peptide levels. At 6 months. CDC, cardiosphere-derived cell how to get prescribed benicar.

LVEDV, left ventricular end-diastolic volume. LVESV, left ventricular end-systolic volume. NT-proBNP, N-terminal pro b-type natriuretic peptide (from Makkar RR, Kereiakes DJ, Aguirre F, Kowalchuk G, Chakravarty T, Malliaras K, Francis GS, Povsic TJ, Schatz R, Traverse JH, Pogoda JM, Smith RR, Marbán L, Ascheim DD, Ostovaneh MR, Lima JAC, DeMaria A, Marbán how to get prescribed benicar E, Henry TD. Intracoronary ALLogeneic heart STem cells to Achieve myocardial Regeneration (ALLSTAR). A randomized, placebo-controlled, double-blinded trial.

See pages 3451--3458).Figure 2Secondary efficacy endpoints comparing cardiosphere-derived cells and placebo how to get prescribed benicar at 6 months. Change in (A) left ventricular end-diastolic volume. (B) left ventricular how to get prescribed benicar end-systolic volume. And (C) N-terminal pro b-type natriuretic peptide levels. At 6 months.

CDC, cardiosphere-derived how to get prescribed benicar cell. LVEDV, left ventricular end-diastolic volume. LVESV, left ventricular end-systolic volume. NT-proBNP, N-terminal pro b-type natriuretic peptide (from Makkar RR, Kereiakes DJ, Aguirre F, Kowalchuk G, Chakravarty T, Malliaras K, Francis GS, Povsic TJ, Schatz R, how to get prescribed benicar Traverse JH, Pogoda JM, Smith RR, Marbán L, Ascheim DD, Ostovaneh MR, Lima JAC, DeMaria A, Marbán E, Henry TD. Intracoronary ALLogeneic heart STem cells to Achieve myocardial Regeneration (ALLSTAR).

A randomized, placebo-controlled, double-blinded trial. See pages 3451--3458).The authors conclude how to get prescribed benicar that in contemporary ischaemic/dilated cardiomyopathy patients (LVEF ≤35%, narrow QRS), primary prophylactic ICD treatment was associated with a substantial reduction in mortality, although this improvement was not consistent across the whole population. The manuscript is accompanied by an Editorial by N.A. Mark Estes III from the Heart and Vascular Institute UPMC in Pittsburgh, Pennsylvania, USA.11 The authors note that clinicians should be mindful of available risk stratification models and subgroup analyses from the EU-CERT-ICD and how to get prescribed benicar other studies. It follows that the process of shared decision-making should include careful consideration of the patient’s wishes and values, with an individualized assessment of potential benefit and risks of primary prevention of sudden death by ICD implantation.Cardiosphere-derived cells (CDCs) are cardiac progenitor cells which exhibit disease-modifying bioactivity in various models of cardiomyopathy and in previous clinical studies of acute myocardial infarction (MI), dilated cardiomyopathy, and Duchenne muscular dystrophy.12,13 In a clinical research article entitled ‘Intracoronary ALLogeneic heart STem cells to Achieve myocardial Regeneration (ALLSTAR).

A randomized, placebo-controlled, double-blinded trial’, Raj Makkar from the Cedars-Sinai Heart Institute in Los Angeles, California, USA and colleagues assessed the safety and efficacy of intracoronary administration of allogeneic CDCs in the multicentre, randomized, double-blind, placebo-controlled, intracoronary ALLogeneic Heart STem Cells to Achieve Myocardial Regeneration (ALLSTAR) trial.14 The authors enrolled patients 4 weeks to 12 months after MI, with LVEF ≤45% and left ventricular LV scar size ≥15% of LVM by MRI. A pre-specified interim analysis was performed when 6-month MRI how to get prescribed benicar data were available. The trial was subsequently stopped due to the low probability of detecting a significant treatment effect of CDCs based on the primary endpoint. Patients were randomly allocated in a 2:1 ratio to receive CDCs or placebo in the infarct-related artery by the stop–flow technique. The primary safety endpoint was the occurrence, during 1-month post-intracoronary infusion, of acute myocarditis attributable to allogeneic CDCs, ventricular tachycardia- or ventricular fibrillation-related death, sudden unexpected death, or a major adverse cardiac event (death or hospitalization for HF or non-fatal how to get prescribed benicar MI).

The primary efficacy endpoint was the relative percentage change in infarct size at 12 months post-infusion as assessed by contrast-enhanced cardiac MRI. Makkar and colleagues randomly allocated 90 patients to the CDC group and how to get prescribed benicar 44 to the placebo group. The mean baseline LVEF was 40% and the mean scar size was 22% of the LVM. No primary safety endpoint events occurred. There was no difference in the percentage change from baseline in how to get prescribed benicar scar size between CDC and placebo groups at 6 months.

Compared with placebo, there were significant reductions in LV end-diastolic volume, LV end-systolic volume, and NT-proBNP at 6 months in CDC-treated patients.The authors conclude that intracoronary infusion of allogeneic CDCs in patients with post-MI left ventricular dysfunction was safe but did not reduce scar size relative to placebo at 6 months. The manuscript is accompanied by an Editorial by Francisco Fernandez-Aviles from the Hospital General Universitario Gregorio Marañón in Madrid, Spain and colleagues.15 The authors feel that various points need to be better addressed before proceeding again to clinical trials, if we want to move the field of cardiovascular regenerative and reparative medicine forward, for the sake of the cardiovascular health of millions of patients.Treatment of pathological cardiac remodelling and subsequent HF represents an unmet clinical need. Long non-coding RNAs (lncRNAs) are emerging as crucial molecular orchestrators of disease processes including that of heart diseases.16,17 In a Basic Science article entitled ‘Targeting muscle-enriched long non-coding RNA H19 reverses pathological cardiac hypertrophy’, Thomas Thum from the Hannover Medical School in Germany, and colleagues report on the powerful therapeutic potential of the conserved lncRNA H19 in the treatment of pathological cardiac hypertrophy.18 Pressure overload-induced left ventricular cardiac remodelling revealed an up-regulation of how to get prescribed benicar H19 in the early phase, but a strong sustained repression upon reaching the decompensated phase of HF. The translational potential of H19 was highlighted by its repression in a large animal (pig) model of LVH, in diseased human heart samples, in human stem cell-derived cardiomyocytes, and in human engineered heart tissue in response to afterload enhancement. Pressure overload-induced cardiac hypertrophy in H19 knockout mice was aggravated compared with wild-type mice.

In contrast, how to get prescribed benicar vector-based, cardiomyocyte-directed gene therapy using murine but also human H19 strongly attenuated HF even when cardiac hypertrophy was already established. Mechanistically, using microarray, gene set enrichment analyses, and chromatin immunoprecipitation-DNA sequencing, the authors identified a link between H19 and prohypertrophic nuclear factor of activated T cells (NFAT) signalling. H19 physically interacts with the polycomb repressive complex 2 to suppress H3K27 tri-methylation of the antihypertrophic Tescalcin locus which in turn leads to reduced NFAT expression and activity.Thum and colleagues conclude that how to get prescribed benicar H19 is highly conserved and down-regulated in failing hearts from mice, pigs, and humans. H19 gene therapy prevents and reverses experimental pressure overload-induced HF. H19 acts as an antihypertrophic lncRNA and represents a promising therapeutic target to combat pathological cardiac remodelling.

The manuscript is accompanied how to get prescribed benicar by an Editorial by Gianluigi Condorelli from the Humanitas University in Rozzano, Italy and colleagues. The authors note that dysregulation of epigenetic mechanisms leading to aberrant loss of cardiomyocyte homeostasis is a critical point to consider in understanding the onset of cardiovascular pathologies. Thus exploiting lncRNAs as therapeutic agents in myocardial disease could pave the way for efficaciously combatting one of the greatest healthcare burdens worldwide.19With the advent of omics, an innovative inductive method has provided researchers with possible ways new to monitor health and disease. This approach incorporates data from studies of the genome, transcriptome, proteome, and metabolome to focus on the assessment of a varied range of biomolecules.20 In a clinical review how to get prescribed benicar article entitled ‘Omics phenotyping in heart failure. The next frontier’ Antoni Bayes-Genis from the Cardiology Service, Hospital Universitari Germans Trias i Pujol in Badalona, Spain and colleagues provide a state-of-the-art review aiming to provide an up-to-date look at breakthrough omic technologies that are helping to unravel HF disease mechanisms and heterogeneity.21 Genomics, transcriptomics, proteomics, and metabolomics in HF are reviewed in depth.

In addition, there is a thorough, expert discussion regarding the value of omics in identifying novel disease pathways, advancing understanding of disease mechanisms, differentiating HF phenotypes, yielding biomarkers for diagnosis or prognosis, or identifying new therapeutic targets in HF. The combination of multiple omics technologies may create a more comprehensive picture of the factors and pathophysiology involved in HF than achieved by either one alone, and provides how to get prescribed benicar a rich resource for predictive phenotype modelling. However, the successful translation of omics tools as solutions to clinical HF requires that the observations are robust and reproducible, and can be validated across multiple independent populations to ensure confidence in clinical decision-making.This issue is also complemented by a Discussion Forum contribution. In a contribution entitled how to get prescribed benicar ‘Heart failure development in obesity. Mechanistic pathways’ Kristjan Karason from the Sahlgrenska University Hospital in Gothenburg, Sweden and colleagues provide a reply to a recent comment entitled ‘Incident heart failure risk after bariatric surgery.

The role of epicardial fat’.22,23The editors hope that this issue of the European Heart Journal will be of interest to its readers.With thanks to Amelia Meier-Batschelet, Johanna Hugger, and Martin Meyer for help with compilation of this article. References1Docherty KF, Jhund PS, Inzucchi SE, Køber L, Kosiborod MN, Martinez FA, Ponikowski P, DeMets DL, Sabatine MS, Bengtsson O, Sjöstrand M, Langkilde AM, Desai AS, Diez M, Howlett how to get prescribed benicar JG, Katova T, Ljungman CEA, O’Meara E, Petrie MC, Schou M, Verma S, Vinh PN, Solomon SD, McMurray JJV. Effects of dapagliflozin in DAPA-HF according to background heart failure therapy. Eur Heart J 2020;41:2379–2392.2Ponikowski P, Voors AA,, Anker SD, Bueno H, Cleland JGF, Coats AJS, Falk V, González-Juanatey JR, Harjola VP, Jankowska EA, Jessup M, Linde C, Nihoyannopoulos P, Parissis JT, Pieske B, Riley JP, Rosano GMC, Ruilope LM, Ruschitzka F, Rutten FH, van der Meer P. 2016 ESC Guidelines for the diagnosis and treatment of acute how to get prescribed benicar and chronic heart failure.

The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC). Developed with the special contribution of the Heart Failure Association (HFA) of how to get prescribed benicar the ESC. Eur Heart J 2016;37:2129–2200.3Packer M. Are the benefits of SGLT2 inhibitors in heart failure and a reduced ejection fraction influenced by background therapy?. Expectations and realities of how to get prescribed benicar a new standard of care.

Eur Heart J 2020;41:2393–2396.4Butler J, Zannad F, Filippatos G, Anker SD, Packer M. Totality of evidence in trials of sodium–glucose co-transporter-2 inhibitors in the patients with heart failure with reduced ejection fraction. Implications for how to get prescribed benicar clinical practice. Eur Heart J 2020;41:3398–3401.5Serenelli M, Böhm M, Inzucchi SE, Køber L, Kosiborod MN, Martinez FA, Ponikowski P,, Sabatine MS, Solomon SD, DeMets DL, Bengtsson O, Sjöstrand M, Langkilde AM, Anand IS, Chiang CE, Chopra VK, de Boer RA, Diez M, Dukát A, Ge J, Howlett JG, Katova T, Kitakaze M, Ljungman CEA, Verma S,, Docherty KF, Jhund PS, McMurray JJV. Effect of dapagliflozin according to baseline systolic blood pressure in the Dapagliflozin and Prevention of Adverse Outcomes in Heart Failure trial (DAPA-HF).

Eur Heart J 2020;41:3402–3418.6Savarese how to get prescribed benicar G, Cosentino F. The interaction between dapagliflozin and blood pressure in heart failure. New evidence how to get prescribed benicar dissipating concerns. Eur Heart J 2020;41:3419–3420.7Brown AJM, Gandy S, McCrimmon R, Houston JG, Struthers AD, Lang CC. A randomized controlled trial of dapagliflozin on left ventricular hypertrophy in people with type two diabetes.

The DAPA-LVH how to get prescribed benicar trial. Eur Heart J 2020;41:3421–3432.8Paneni F, Costantino S, Hamdani N. Regression of left ventricular hypertrophy with SGLT2 inhibitors. Eur Heart how to get prescribed benicar J 2020;41:3433–3436.9Priori SG, Blomström-Lundqvist C, Mazzanti A, Blom N, Borggrefe M, Camm J, Elliott PM, Fitzsimons D, Hatala R, Hindricks G, Kirchhof P, Kjeldsen K, Kuck KH, Hernandez-Madrid A, Nikolaou N, Norekvål TM, Spaulding C, Van Veldhuisen DJ. 2015 ESC Guidelines for the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death.

The Task Force for the how to get prescribed benicar Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death of the European Society of Cardiology (ESC). Endorsed by. Association for European Paediatric and Congenital Cardiology (AEPC). Eur Heart J 2015;36:2793–2867.10Zabel M, Willems R, Lubinski A, Bauer A, Brugada J, Conen D, Flevari P, Hasenfuß G, Svetlosak M, Huikuri HV, Malik M, Pavlović N, Schmidt G, Sritharan R, Schlögl S, Szavits-Nossan J, Traykov how to get prescribed benicar V, Tuinenburg AE, Willich SN, Harden M, Friede T, Svendsen JH, Sticherling C, Merkely B. Clinical effectiveness of primary prevention implantable cardioverter-defibrillators.

Results of the EU-CERT-ICD controlled multicentre cohort study. Eur Heart J how to get prescribed benicar 2020;41:3437–3447.11Estes MNA, Saba S. Primary prevention of sudden death with the implantable cardioverter defibrillator. Bridging the evidence gap. Eur Heart how to get prescribed benicar J 2020;41:3448–3450.12Aminzadeh MA, Tseliou E, Sun B, Cheng K, Malliaras K, Makkar RR, Marbán E.

Therapeutic efficacy of cardiosphere-derived cells in a transgenic mouse model of non-ischaemic dilated cardiomyopathy. Eur Heart J 2015;36:751–762.13Fadini GP, Mehta A, Dhindsa DS, Bonora BM, how to get prescribed benicar Sreejit G, Nagareddy P, Quyyumi AA. Circulating stem cells and cardiovascular outcomes. From basic science to the clinic. Eur Heart how to get prescribed benicar J 2020.

Doi:10.1093/eurheartj/ehz923.14Makkar RR, Kereiakes DJ, Aguirre F, Kowalchuk G, Chakravarty T, Malliaras K, Francis GS, Povsic TJ, Schatz R, Traverse JH, Pogoda JM, Smith RR, Marbán L, Ascheim DD, Ostovaneh MR, Lima JAC, DeMaria A, Marbán E, Henry TD. Intracoronary ALLogeneic heart STem cells to Achieve myocardial Regeneration (ALLSTAR). A randomized, placebo-controlled, how to get prescribed benicar double-blinded trial. Eur Heart J 2020;41:3451–3458.15Sanz-Ruiz R, Fernández-Avilés F. Cardiovascular regenerative and reparative medicine.

Is myocardial how to get prescribed benicar infarction the model?. Eur Heart J 2020;41:3459–3461.16Ounzain S, Micheletti R, Beckmann T, Schroen B, Alexanian M, Pezzuto I, Crippa S, Nemir M, Sarre A, Johnson R, Dauvillier J, Burdet F, Ibberson M, Guigó R, Xenarios I, Heymans S, Pedrazzini T. Genome-wide profiling of the cardiac transcriptome after myocardial infarction identifies how to get prescribed benicar novel heart-specific long non-coding RNAs. Eur Heart J 2015;36:353–368.17Lüscher TF. Novel molecular mechanisms of vascular disease.

Non-coding RNAs, inflammation, and how to get prescribed benicar radiation. Eur Heart J. 2020;40:2467–2470.18Viereck J, Bührke A, Foinquinos A, Chatterjee S, Kleeberger JA, Xiao K, Janssen-Peters H, Batkai S, Ramanujam D, Kraft T, Cebotari S, Gueler F, Beyer AM, Schmitz J, Bräsen JH, Schmitto JD, Gyöngyösi M, Löser A, Hirt MN, Eschenhagen T, Engelhardt S, Bär C, Thum T. Targeting muscle-enriched long non-coding RNA H19 reverses pathological cardiac hypertrophy how to get prescribed benicar. Eur Heart J 2020;41:3462–3474.19Pagiatakis C, Hall IF, Condorelli G.

Long non-coding how to get prescribed benicar RNA H19. A new avenue for RNA therapeutics in cardiac hypertrophy?. Eur Heart J 2020;41:3475–3476.20Hoogeveen RM, Pereira JPB, Nurmohamed NS, Zampoleri V, Bom MJ, Baragetti A, Boekholdt SM, Knaapen P, Khaw KT, Wareham NJ, Groen AK, Catapano AL, Koenig W, Levin E, Stroes ESG. Improved cardiovascular risk prediction using targeted plasma how to get prescribed benicar proteomics in primary prevention. Eur Heart J 2020;ehaa648.

21Bayes-Genis A, Liu PP, Lanfear DE, de Boer RA, González A, Thum T, Emdin M, Januzzi JL. Omics phenotyping in heart how to get prescribed benicar failure. The next frontier. Eur Heart J 2020;41:3477–3484.22Karason K, Jamaly S. Heart failure development in how to get prescribed benicar obesity.

Mechanistic pathways. Eur Heart J 2020;41:3485.23van Woerden how to get prescribed benicar G, van Veldhuisen SL, Rienstra M. Incident heart failure risk after bariatric surgery. The role of epicardial fat. Eur Heart J how to get prescribed benicar 2020;41:1775.

Published on behalf of the European Society of Cardiology. All rights reserved. © The how to get prescribed benicar Author(s) 2020. For permissions, please email. Journals.permissions@oup.com..

€‚For the podcast associated benicar online pharmacy with this article, please visit https://academic.oup.com/eurheartj/pages/Podcasts.This Focus Issue on heart failure (HF) provides novel clinically relevant information on sodium–glucose co-transporter-2 (SGLT2) inhibitors which, initially proposed for the treatment of type 2 diabetes mellitus (T2D), have been found to improve the outcome of HF with reduced ejection fraction (HFrEF) when administered on the top of drugs known to improve the outcome of HF and are recommended in current European Guidelines.1,2Acording to modelling estimates, when compared with no neurohormonal blockade, the use of a broad-based combination of disease-modifying drugs at target doses in patients with HF may reduce the risk of death by as much as 75%. It is surprising that in spite of this powerful therapeutic armamentarium, <1% of patients with chronic HF are currently receiving recommended drugs at doses that have been shown to prolong life.3 The issue opens with a Current Opinion article entitled ‘Totality of evidence in trials of sodium–glucose co-transporter-2 inhibitors in the patients with heart failure with reduced ejection fraction. Implications for clinical practice’ benicar online pharmacy by Milton Packer from the Baylor University Medical Center at Dallas in Texas, USA and colleagues. The authors provide a perspective on the totality of evidence with SGLT2 inhibitors in patients with HFrEF.4 This paper is the first to issue a call for a major change in clinical practice based on the concordant results of DAPA-HF and EMPEROR-Reduced trials.

The analyses and interpretations that are presented in this manuscript will undoubtedly generate considerable discussion and debate for a long time.Concern about hypotension often leads to withholding of beneficial therapy in patients with HFrEF. In a clinical research manuscript entitled ‘Effect of dapagliflozin according to baseline systolic blood pressure in the Dapagliflozin and Prevention of benicar online pharmacy Adverse Outcomes in Heart Failure trial (DAPA-HF)’ John McMurray from the Western Infirmary in Glasgow, UK and colleagues on behalf of the DAPA-HF Investigators and Committees evaluated the efficacy and safety of dapagliflozin according to baseline systolic blood pressure (SBP) in DAPA-HF trial.5 Key inclusion criteria were. New York Heart Association (NYHA) class II–IV, left ventricular ejection fraction (LVEF) ≤40%, elevated N-terminal probrain natriuretic peptide (NT-proBNP) level, and SBP ≥95 mmHg. The primary outcome was a composite of worsening HF or cardiovascular death.

The efficacy and safety of dapagliflozin was examined using SBP as both a categorical and a continuous variable benicar online pharmacy. The placebo-corrected reduction in SBP from baseline to 2 weeks with dapagliflozin was –2.54 mmHg. The benefit benicar online pharmacy and safety of dapagliflozin were consistent across the range of SBP. Study drug discontinuation did not differ between dapagliflozin and placebo across the SBP categories examined.The authors conclude that dapagliflozin had a small effect on SBP in patients with HFrEF and was superior to placebo in improving outcomes, and well tolerated, across the range of SBP included in DAPA-HF.

The manuscript is accompanied by an Editorial by Francesco Cosentino from the University Hospital Solna in Stockholm, Sweden who comments that altogether, the results of the current post-hoc analysis demonstrating efficacy and safety of dapagliflozin regardless of SBP values might significantly contribute to foster the implementation of dapagliflozin use in HF clinical practice by dissipating any potential safety concern linked with its hypotensive effects.6In a clinical research article entitled ‘A randomized controlled trial of dapagliflozin on left ventricular hypertrophy in people with type two diabetes. The DAPA-LVH benicar online pharmacy trial’, Chim Lang from the University of Dundee in the UK and colleagues tested the hypothesis that dapagliflozin may regress left ventricular hypertrophy (LVH) in people with T2D.7 The authors randomly assigned 66 patients with T2D, LVH, and controlled blood pressure to receive dapagliflozin 10 mg once daily or placebo for 12 months. The primary endpoint was change in absolute left ventricular mass (LVM), assessed by cardiac magnetic resonance imaging (MRI). In the intention-to-treat analysis, dapagliflozin significantly reduced LVM compared with placebo, with an absolute mean change of –2.82 g.

Additional sensitivity analysis adjusting for baseline LVM, baseline blood pressure, weight, and SBP change showed the benicar online pharmacy LVM change to remain statistically significant. Dapagliflozin significantly reduced pre-specified secondary endpoints including ambulatory 24-h SBP, nocturnal SBP, body weight, visceral adipose tissue, subcutaneous adipose tissue, insulin resistance, and high-sensitivity C-reactive protein. Figure 1Column bar charts showing the mean regression of left ventricular mass following dapagliflozin treatment compared to placebo (from Brown AJM, Gandy S, McCrimmon R, Houston JG, Struthers AD, Lang CC. A randomized controlled trial of dapagliflozin on left benicar online pharmacy ventricular hypertrophy in people with type two diabetes.

The DAPA-LVH trial. See pages 3421–3432).Figure 1Column bar charts showing the mean regression of left ventricular mass following dapagliflozin treatment compared to placebo benicar online pharmacy (from Brown AJM, Gandy S, McCrimmon R, Houston JG, Struthers AD, Lang CC. A randomized controlled trial of dapagliflozin on left ventricular hypertrophy in people with type two diabetes. The DAPA-LVH trial.

See pages 3421–3432).Lang and benicar online pharmacy colleagues conclude that dapagliflozin treatment significantly reduced LVM in patients with T2D and LVH. The regression of LVM suggests that dapagliflozin can initiate reverse remodelling and changes in left ventricular structure that may partly contribute to cardioprotective effects of dapagliflozin. This manuscript is accompanied by an Editorial by Francesco Paneni from the University of Zurich in Switzerland and colleagues.8 They note that the above-mentioned effects of SGLT2 inhibitors set the ground for a possible beneficial effect of these drugs in patients with HFpEF, where microvascular dysfunction, cardiomyocyte inflammation, and cardiometabolic alterations take centre stage.While several landmark studies have long established that implantable cardioverter-defibrillator (ICD) therapy improves survival for primary prevention of sudden cardiac death ,9 risk stratification parameters and methods for this purpose are clinically underused. In a clinical research article entitled ‘Clinical effectiveness of primary prevention implantable cardioverter-defibrillators benicar online pharmacy.

Results of the EU-CERT-ICD controlled multicentre cohort study’ Markus Zabel from the Universitätsmedizin Göttingen in Germany and colleagues from the EU-CERT-ICD Study Investigators assessed the current clinical effectiveness of primary prevention by ICD therapy in a prospective investigator-initiated, controlled cohort study, conducted in 44 centres and 15 European countries. The study sought to benicar online pharmacy assess current clinical effectiveness of primary prophylactic ICD implantation.10 The authors recruited 2327 patients with ischaemic or dilated cardiomyopathy and guideline indications for prophylactic ICD implantation. The primary endpoint was all-cause mortality. Baseline and follow-up data from 2247 patients were analysable.

1516 patients with benicar online pharmacy first ICD implantation (ICD group) and 731 patients without ICD serving as controls. Multivariable models and propensity scoring for adjustment were used to compare the two groups for mortality. Adjusted mortality associated with ICD vs. Control was significantly benicar online pharmacy lower (hazard ratio 0.731).

Subgroup analyses indicated no ICD benefit in diabetics or in those aged ≥75 years. Figure 2Secondary efficacy endpoints comparing cardiosphere-derived cells and placebo at 6 months. Change in (A) left benicar online pharmacy ventricular end-diastolic volume. (B) left ventricular end-systolic volume.

And (C) N-terminal pro b-type natriuretic peptide levels benicar online pharmacy. At 6 months. CDC, cardiosphere-derived cell. LVEDV, left ventricular end-diastolic benicar online pharmacy volume.

LVESV, left ventricular end-systolic volume. NT-proBNP, N-terminal pro b-type natriuretic peptide (from Makkar RR, Kereiakes DJ, Aguirre F, Kowalchuk G, Chakravarty T, Malliaras K, Francis GS, Povsic TJ, Schatz R, Traverse JH, Pogoda JM, Smith RR, Marbán L, Ascheim DD, Ostovaneh MR, Lima JAC, DeMaria A, Marbán E, Henry TD. Intracoronary ALLogeneic heart STem cells benicar online pharmacy to Achieve myocardial Regeneration (ALLSTAR). A randomized, placebo-controlled, double-blinded trial.

See pages 3451--3458).Figure 2Secondary efficacy endpoints comparing cardiosphere-derived cells and placebo at 6 months. Change in benicar online pharmacy (A) left ventricular end-diastolic volume. (B) left ventricular end-systolic volume. And (C) N-terminal pro b-type benicar online pharmacy natriuretic peptide levels.

At 6 months. CDC, cardiosphere-derived cell. LVEDV, left benicar online pharmacy ventricular end-diastolic volume. LVESV, left ventricular end-systolic volume.

NT-proBNP, N-terminal pro b-type natriuretic peptide (from Makkar RR, Kereiakes DJ, Aguirre F, Kowalchuk G, Chakravarty T, Malliaras K, Francis GS, Povsic TJ, Schatz R, Traverse JH, Pogoda JM, Smith RR, Marbán L, Ascheim DD, Ostovaneh MR, Lima JAC, DeMaria A, Marbán E, Henry TD. Intracoronary ALLogeneic benicar online pharmacy heart STem cells to Achieve myocardial Regeneration (ALLSTAR). A randomized, placebo-controlled, double-blinded trial. See pages 3451--3458).The authors conclude that in contemporary ischaemic/dilated cardiomyopathy patients (LVEF ≤35%, narrow QRS), primary prophylactic ICD benicar online pharmacy treatment was associated with a substantial reduction in mortality, although this improvement was not consistent across the whole population.

The manuscript is accompanied by an Editorial by N.A. Mark Estes III from the Heart and Vascular Institute UPMC in Pittsburgh, Pennsylvania, USA.11 The authors note that clinicians should be mindful of available risk stratification models and subgroup analyses from the EU-CERT-ICD and other studies. It follows that the process of shared decision-making should include careful consideration of the patient’s wishes and values, with an individualized assessment of potential benefit and risks of primary prevention of sudden death by ICD implantation.Cardiosphere-derived cells (CDCs) are cardiac progenitor cells which exhibit disease-modifying bioactivity in various models of cardiomyopathy and in previous clinical studies of acute myocardial infarction (MI), dilated cardiomyopathy, and Duchenne muscular dystrophy.12,13 In a clinical research article entitled ‘Intracoronary ALLogeneic heart STem cells to Achieve myocardial Regeneration benicar online pharmacy (ALLSTAR). A randomized, placebo-controlled, double-blinded trial’, Raj Makkar from the Cedars-Sinai Heart Institute in Los Angeles, California, USA and colleagues assessed the safety and efficacy of intracoronary administration of allogeneic CDCs in the multicentre, randomized, double-blind, placebo-controlled, intracoronary ALLogeneic Heart STem Cells to Achieve Myocardial Regeneration (ALLSTAR) trial.14 The authors enrolled patients 4 weeks to 12 months after MI, with LVEF ≤45% and left ventricular LV scar size ≥15% of LVM by MRI.

A pre-specified interim analysis was performed when 6-month MRI data were available. The trial was subsequently stopped benicar online pharmacy due to the low probability of detecting a significant treatment effect of CDCs based on the primary endpoint. Patients were randomly allocated in a 2:1 ratio to receive CDCs or placebo in the infarct-related artery by the stop–flow technique. The primary safety endpoint was the occurrence, during 1-month post-intracoronary infusion, of acute myocarditis attributable to allogeneic CDCs, ventricular tachycardia- or ventricular fibrillation-related death, sudden unexpected death, or a major adverse cardiac event (death or hospitalization for HF or non-fatal MI).

The primary efficacy endpoint was the relative percentage benicar online pharmacy change in infarct size at 12 months post-infusion as assessed by contrast-enhanced cardiac MRI. Makkar and colleagues randomly allocated 90 patients to the CDC group and 44 to the placebo group. The mean baseline LVEF was 40% and the mean scar size was benicar online pharmacy 22% of the LVM. No primary safety endpoint events occurred.

There was no difference in the percentage change from baseline in scar size between CDC and placebo groups at 6 months. Compared with placebo, there were significant reductions in LV end-diastolic volume, LV end-systolic volume, and NT-proBNP at 6 months in CDC-treated patients.The authors conclude that intracoronary infusion of allogeneic CDCs in patients with post-MI left ventricular benicar online pharmacy dysfunction was safe but did not reduce scar size relative to placebo at 6 months. The manuscript is accompanied by an Editorial by Francisco Fernandez-Aviles from the Hospital General Universitario Gregorio Marañón in Madrid, Spain and colleagues.15 The authors feel that various points need to be better addressed before proceeding again to clinical trials, if we want to move the field of cardiovascular regenerative and reparative medicine forward, for the sake of the cardiovascular health of millions of patients.Treatment of pathological cardiac remodelling and subsequent HF represents an unmet clinical need. Long non-coding RNAs (lncRNAs) are emerging as crucial molecular orchestrators of disease processes including that of heart diseases.16,17 In a Basic Science article entitled ‘Targeting muscle-enriched long non-coding RNA H19 reverses pathological cardiac hypertrophy’, Thomas Thum from the Hannover Medical School in Germany, and colleagues report on the powerful therapeutic potential of the conserved lncRNA H19 in the treatment of pathological cardiac hypertrophy.18 Pressure overload-induced left ventricular cardiac remodelling revealed an up-regulation of H19 in the early phase, but a strong sustained repression upon reaching the decompensated phase of HF.

The translational potential of H19 was highlighted by its benicar online pharmacy repression in a large animal (pig) model of LVH, in diseased human heart samples, in human stem cell-derived cardiomyocytes, and in human engineered heart tissue in response to afterload enhancement. Pressure overload-induced cardiac hypertrophy in H19 knockout mice was aggravated compared with wild-type mice. In contrast, vector-based, cardiomyocyte-directed gene therapy using murine but also human H19 strongly attenuated HF even when cardiac hypertrophy benicar online pharmacy was already established. Mechanistically, using microarray, gene set enrichment analyses, and chromatin immunoprecipitation-DNA sequencing, the authors identified a link between H19 and prohypertrophic nuclear factor of activated T cells (NFAT) signalling.

H19 physically interacts with the polycomb repressive complex 2 to suppress H3K27 tri-methylation of the antihypertrophic Tescalcin locus which in turn leads to reduced NFAT expression and activity.Thum and colleagues conclude that H19 is highly conserved and down-regulated in failing hearts from mice, pigs, and humans. H19 gene therapy prevents benicar online pharmacy and reverses experimental pressure overload-induced HF. H19 acts as an antihypertrophic lncRNA and represents a promising therapeutic target to combat pathological cardiac remodelling. The manuscript is accompanied by an Editorial by Gianluigi Condorelli from the Humanitas University in Rozzano, Italy and colleagues.

The authors note benicar online pharmacy that dysregulation of epigenetic mechanisms leading to aberrant loss of cardiomyocyte homeostasis is a critical point to consider in understanding the onset of cardiovascular pathologies. Thus exploiting lncRNAs as therapeutic agents in myocardial disease could pave the way for efficaciously combatting one of the greatest healthcare burdens worldwide.19With the advent of omics, an innovative inductive method has provided researchers with possible ways new to monitor health and disease. This approach incorporates data from studies of the genome, transcriptome, proteome, and metabolome to focus on the assessment of a varied range of biomolecules.20 In a clinical review article entitled ‘Omics phenotyping in heart failure. The next frontier’ Antoni Bayes-Genis from the Cardiology Service, Hospital Universitari Germans Trias i Pujol in Badalona, Spain and colleagues provide a state-of-the-art review aiming to provide an up-to-date look at breakthrough omic technologies that are helping benicar online pharmacy to unravel HF disease mechanisms and heterogeneity.21 Genomics, transcriptomics, proteomics, and metabolomics in HF are reviewed in depth.

In addition, there is a thorough, expert discussion regarding the value of omics in identifying novel disease pathways, advancing understanding of disease mechanisms, differentiating HF phenotypes, yielding biomarkers for diagnosis or prognosis, or identifying new therapeutic targets in HF. The combination of multiple omics technologies may create a more comprehensive picture of the benicar online pharmacy factors and pathophysiology involved in HF than achieved by either one alone, and provides a rich resource for predictive phenotype modelling. However, the successful translation of omics tools as solutions to clinical HF requires that the observations are robust and reproducible, and can be validated across multiple independent populations to ensure confidence in clinical decision-making.This issue is also complemented by a Discussion Forum contribution. In a contribution entitled ‘Heart failure development in obesity.

Mechanistic pathways’ Kristjan Karason from the Sahlgrenska University Hospital in Gothenburg, Sweden and colleagues provide a reply to a recent benicar online pharmacy comment entitled ‘Incident heart failure risk after bariatric surgery. The role of epicardial fat’.22,23The editors hope that this issue of the European Heart Journal will be of interest to its readers.With thanks to Amelia Meier-Batschelet, Johanna Hugger, and Martin Meyer for help with compilation of this article. References1Docherty KF, Jhund PS, Inzucchi SE, Køber L, Kosiborod MN, Martinez FA, Ponikowski P, DeMets DL, Sabatine MS, Bengtsson O, Sjöstrand M, Langkilde AM, Desai AS, Diez M, Howlett JG, Katova T, Ljungman CEA, O’Meara E, Petrie MC, Schou M, Verma S, Vinh PN, Solomon SD, McMurray JJV. Effects of dapagliflozin benicar online pharmacy in DAPA-HF according to background heart failure therapy.

Eur Heart J 2020;41:2379–2392.2Ponikowski P, Voors AA,, Anker SD, Bueno H, Cleland JGF, Coats AJS, Falk V, González-Juanatey JR, Harjola VP, Jankowska EA, Jessup M, Linde C, Nihoyannopoulos P, Parissis JT, Pieske B, Riley JP, Rosano GMC, Ruilope LM, Ruschitzka F, Rutten FH, van der Meer P. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology benicar online pharmacy (ESC). Developed with the special contribution of the Heart Failure Association (HFA) of the ESC.

Eur Heart J benicar online pharmacy 2016;37:2129–2200.3Packer M. Are the benefits of SGLT2 inhibitors in heart failure and a reduced ejection fraction influenced by background therapy?. Expectations and realities of a new standard of care. Eur Heart J 2020;41:2393–2396.4Butler J, Zannad F, Filippatos G, Anker benicar online pharmacy SD, Packer M.

Totality of evidence in trials of sodium–glucose co-transporter-2 inhibitors in the patients with heart failure with reduced ejection fraction. Implications for clinical practice. Eur Heart J 2020;41:3398–3401.5Serenelli M, Böhm M, Inzucchi SE, Køber L, Kosiborod MN, Martinez FA, Ponikowski P,, Sabatine MS, Solomon SD, DeMets DL, Bengtsson O, Sjöstrand M, Langkilde AM, Anand IS, Chiang CE, Chopra VK, de Boer RA, Diez M, Dukát A, Ge J, Howlett JG, Katova T, Kitakaze M, Ljungman CEA, Verma S,, Docherty KF, Jhund PS, McMurray JJV benicar online pharmacy. Effect of dapagliflozin according to baseline systolic blood pressure in the Dapagliflozin and Prevention of Adverse Outcomes in Heart Failure trial (DAPA-HF).

Eur Heart J 2020;41:3402–3418.6Savarese G, benicar online pharmacy Cosentino F. The interaction between dapagliflozin and blood pressure in heart failure. New evidence dissipating concerns. Eur Heart J 2020;41:3419–3420.7Brown AJM, Gandy benicar online pharmacy S, McCrimmon R, Houston JG, Struthers AD, Lang CC.

A randomized controlled trial of dapagliflozin on left ventricular hypertrophy in people with type two diabetes. The DAPA-LVH trial. Eur Heart benicar online pharmacy J 2020;41:3421–3432.8Paneni F, Costantino S, Hamdani N. Regression of left ventricular hypertrophy with SGLT2 inhibitors.

Eur Heart J 2020;41:3433–3436.9Priori SG, Blomström-Lundqvist C, Mazzanti A, Blom N, Borggrefe M, Camm J, Elliott PM, Fitzsimons D, Hatala R, Hindricks G, Kirchhof P, Kjeldsen K, Kuck KH, Hernandez-Madrid A, Nikolaou N, Norekvål TM, Spaulding C, Van Veldhuisen DJ. 2015 ESC Guidelines for the management of patients with ventricular benicar online pharmacy arrhythmias and the prevention of sudden cardiac death. The Task Force for the Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death of the European Society of Cardiology (ESC). Endorsed by benicar online pharmacy.

Association for European Paediatric and Congenital Cardiology (AEPC). Eur Heart J 2015;36:2793–2867.10Zabel M, Willems R, Lubinski A, Bauer A, Brugada J, Conen D, Flevari P, Hasenfuß G, Svetlosak M, Huikuri HV, Malik M, Pavlović N, Schmidt G, Sritharan R, Schlögl S, Szavits-Nossan J, Traykov V, Tuinenburg AE, Willich SN, Harden M, Friede T, Svendsen JH, Sticherling C, Merkely B. Clinical effectiveness of benicar online pharmacy primary prevention implantable cardioverter-defibrillators. Results of the EU-CERT-ICD controlled multicentre cohort study.

Eur Heart J 2020;41:3437–3447.11Estes MNA, Saba S. Primary prevention of sudden death with the implantable benicar online pharmacy cardioverter defibrillator. Bridging the evidence gap. Eur Heart J 2020;41:3448–3450.12Aminzadeh MA, Tseliou E, Sun B, Cheng K, Malliaras K, Makkar RR, Marbán E.

Therapeutic efficacy of cardiosphere-derived cells in benicar online pharmacy a transgenic mouse model of non-ischaemic dilated cardiomyopathy. Eur Heart J 2015;36:751–762.13Fadini GP, Mehta A, Dhindsa DS, Bonora BM, Sreejit G, Nagareddy P, Quyyumi AA. Circulating stem cells and benicar online pharmacy cardiovascular outcomes. From basic science to the clinic.

Eur Heart J 2020. Doi:10.1093/eurheartj/ehz923.14Makkar RR, Kereiakes DJ, Aguirre F, Kowalchuk G, Chakravarty T, Malliaras K, Francis GS, Povsic TJ, Schatz R, Traverse JH, Pogoda JM, Smith RR, Marbán L, Ascheim DD, Ostovaneh MR, Lima JAC, DeMaria A, Marbán E, Henry TD benicar online pharmacy. Intracoronary ALLogeneic heart STem cells to Achieve myocardial Regeneration (ALLSTAR). A randomized, placebo-controlled, double-blinded trial.

Eur Heart J 2020;41:3451–3458.15Sanz-Ruiz benicar online pharmacy R, Fernández-Avilés F. Cardiovascular regenerative and reparative medicine. Is myocardial benicar online pharmacy infarction the model?. Eur Heart J 2020;41:3459–3461.16Ounzain S, Micheletti R, Beckmann T, Schroen B, Alexanian M, Pezzuto I, Crippa S, Nemir M, Sarre A, Johnson R, Dauvillier J, Burdet F, Ibberson M, Guigó R, Xenarios I, Heymans S, Pedrazzini T.

Genome-wide profiling of the cardiac transcriptome after myocardial infarction identifies novel heart-specific long non-coding RNAs. Eur Heart benicar online pharmacy J 2015;36:353–368.17Lüscher TF. Novel molecular mechanisms of vascular disease. Non-coding RNAs, inflammation, and radiation.

Eur Heart J benicar online pharmacy. 2020;40:2467–2470.18Viereck J, Bührke A, Foinquinos A, Chatterjee S, Kleeberger JA, Xiao K, Janssen-Peters H, Batkai S, Ramanujam D, Kraft T, Cebotari S, Gueler F, Beyer AM, Schmitz J, Bräsen JH, Schmitto JD, Gyöngyösi M, Löser A, Hirt MN, Eschenhagen T, Engelhardt S, Bär C, Thum T. Targeting muscle-enriched long non-coding RNA H19 reverses pathological cardiac hypertrophy. Eur Heart J 2020;41:3462–3474.19Pagiatakis C, benicar online pharmacy Hall IF, Condorelli G.

Long non-coding RNA H19. A new benicar online pharmacy avenue for RNA therapeutics in cardiac hypertrophy?. Eur Heart J 2020;41:3475–3476.20Hoogeveen RM, Pereira JPB, Nurmohamed NS, Zampoleri V, Bom MJ, Baragetti A, Boekholdt SM, Knaapen P, Khaw KT, Wareham NJ, Groen AK, Catapano AL, Koenig W, Levin E, Stroes ESG. Improved cardiovascular risk prediction using targeted plasma proteomics in primary prevention.

Eur Heart benicar online pharmacy J 2020;ehaa648. 21Bayes-Genis A, Liu PP, Lanfear DE, de Boer RA, González A, Thum T, Emdin M, Januzzi JL. Omics phenotyping in heart failure. The next benicar online pharmacy frontier.

Eur Heart J 2020;41:3477–3484.22Karason K, Jamaly S. Heart failure development in benicar online pharmacy obesity. Mechanistic pathways. Eur Heart J 2020;41:3485.23van Woerden G, van Veldhuisen SL, Rienstra M.

Incident heart failure risk after bariatric benicar online pharmacy surgery. The role of epicardial fat. Eur Heart J 2020;41:1775. Published on behalf benicar online pharmacy of the European Society of Cardiology.

All rights reserved. © The Author(s) 2020. For permissions, benicar online pharmacy please email. Journals.permissions@oup.com. For the podcast associated with this article, please visit https://academic.oup.com/eurheartj/pages/Podcasts.This Focus Issue on heart failure (HF) provides novel clinically relevant information on sodium–glucose co-transporter-2 (SGLT2) inhibitors which, initially proposed for the treatment of type 2 diabetes mellitus (T2D), have been found to improve the outcome of HF with reduced ejection fraction (HFrEF) when administered on the top of drugs known to improve the outcome of HF and are recommended in current European Guidelines.1,2Acording to modelling estimates, when compared with no neurohormonal blockade, the use of a broad-based combination of disease-modifying drugs at target doses in patients with HF may reduce the risk of death by as much as 75%.

It is surprising that in spite of this powerful therapeutic armamentarium, <1% of patients with chronic HF are currently receiving recommended drugs at doses that have been shown to prolong life.3 The issue opens with a Current Opinion article entitled benicar online pharmacy ‘Totality of evidence in trials of sodium–glucose co-transporter-2 inhibitors in the patients with heart failure with reduced ejection fraction. Implications for clinical practice’ by Milton Packer from the Baylor University Medical Center at Dallas in Texas, USA and colleagues. The authors provide a perspective on the totality of evidence with SGLT2 inhibitors in patients with HFrEF.4 This paper is the first to issue a call for a major change in clinical practice based on the concordant results of DAPA-HF and EMPEROR-Reduced trials. The analyses and interpretations that are presented in this manuscript will undoubtedly generate considerable discussion and debate for a long time.Concern about hypotension often benicar online pharmacy leads to withholding of beneficial therapy in patients with HFrEF.

In a clinical research manuscript entitled ‘Effect of dapagliflozin according to baseline systolic blood pressure in the Dapagliflozin and Prevention of Adverse Outcomes in Heart Failure trial (DAPA-HF)’ John McMurray from the Western Infirmary in Glasgow, UK and colleagues on behalf of the DAPA-HF Investigators and Committees evaluated the efficacy and safety of dapagliflozin according to baseline systolic blood pressure (SBP) in DAPA-HF trial.5 Key inclusion criteria were. New York Heart Association (NYHA) class II–IV, left ventricular ejection fraction (LVEF) ≤40%, elevated N-terminal probrain natriuretic peptide (NT-proBNP) level, and SBP ≥95 mmHg. The primary outcome was a composite of worsening HF or cardiovascular benicar online pharmacy death. The efficacy and safety of dapagliflozin was examined using SBP as both a categorical and a continuous variable.

The placebo-corrected reduction in SBP from baseline to 2 weeks with dapagliflozin was –2.54 mmHg. The benefit and safety benicar online pharmacy of dapagliflozin were consistent across the range of SBP. Study drug discontinuation did not differ between dapagliflozin and placebo across the SBP categories examined.The authors conclude that dapagliflozin had a small effect on SBP in patients with HFrEF and was superior to placebo in improving outcomes, and well tolerated, across the range of SBP included in DAPA-HF. The manuscript is accompanied by an Editorial by Francesco Cosentino from the University Hospital Solna in Stockholm, Sweden who comments that altogether, the results of the current post-hoc analysis demonstrating efficacy and safety of dapagliflozin regardless of SBP values might significantly contribute to foster the implementation of dapagliflozin use in HF clinical practice by dissipating any potential safety concern linked with its hypotensive effects.6In a clinical research article entitled ‘A randomized benicar online pharmacy controlled trial of dapagliflozin on left ventricular hypertrophy in people with type two diabetes.

The DAPA-LVH trial’, Chim Lang from the University of Dundee in the UK and colleagues tested the hypothesis that dapagliflozin may regress left ventricular hypertrophy (LVH) in people with T2D.7 The authors randomly assigned 66 patients with T2D, LVH, and controlled blood pressure to receive dapagliflozin 10 mg once daily or placebo for 12 months. The primary endpoint was change in absolute left ventricular mass (LVM), assessed by cardiac magnetic resonance imaging (MRI). In the intention-to-treat analysis, dapagliflozin benicar online pharmacy significantly reduced LVM compared with placebo, with an absolute mean change of –2.82 g. Additional sensitivity analysis adjusting for baseline LVM, baseline blood pressure, weight, and SBP change showed the LVM change to remain statistically significant.

Dapagliflozin significantly reduced pre-specified secondary endpoints including ambulatory 24-h SBP, nocturnal SBP, body weight, visceral adipose tissue, subcutaneous adipose tissue, insulin resistance, and high-sensitivity C-reactive protein. Figure 1Column bar charts showing the mean regression of left benicar online pharmacy ventricular mass following dapagliflozin treatment compared to placebo (from Brown AJM, Gandy S, McCrimmon R, Houston JG, Struthers AD, Lang CC. A randomized controlled trial of dapagliflozin on left ventricular hypertrophy in people with type two diabetes. The DAPA-LVH trial benicar online pharmacy.

See pages 3421–3432).Figure 1Column bar charts showing the mean regression of left ventricular mass following dapagliflozin treatment compared to placebo (from Brown AJM, Gandy S, McCrimmon R, Houston JG, Struthers AD, Lang CC. A randomized controlled trial of dapagliflozin on left ventricular hypertrophy in people with type two diabetes. The DAPA-LVH trial benicar online pharmacy. See pages 3421–3432).Lang and colleagues conclude that dapagliflozin treatment significantly reduced LVM in patients with T2D and LVH.

The regression of LVM suggests that dapagliflozin can initiate reverse remodelling and changes in left ventricular structure that may partly contribute to cardioprotective effects of dapagliflozin. This manuscript is accompanied by an Editorial by Francesco Paneni from the University of Zurich in Switzerland and colleagues.8 They note that the above-mentioned effects of SGLT2 benicar online pharmacy inhibitors set the ground for a possible beneficial effect of these drugs in patients with HFpEF, where microvascular dysfunction, cardiomyocyte inflammation, and cardiometabolic alterations take centre stage.While several landmark studies have long established that implantable cardioverter-defibrillator (ICD) therapy improves survival for primary prevention of sudden cardiac death ,9 risk stratification parameters and methods for this purpose are clinically underused. In a clinical research article entitled ‘Clinical effectiveness of primary prevention implantable cardioverter-defibrillators. Results of the EU-CERT-ICD controlled multicentre cohort study’ Markus Zabel from the Universitätsmedizin Göttingen in Germany and colleagues from the EU-CERT-ICD Study Investigators assessed the current clinical effectiveness of primary prevention by ICD therapy in a prospective investigator-initiated, controlled cohort study, conducted in 44 centres and 15 European countries.

The study sought to assess current clinical effectiveness of primary prophylactic ICD implantation.10 The authors recruited benicar online pharmacy 2327 patients with ischaemic or dilated cardiomyopathy and guideline indications for prophylactic ICD implantation. The primary endpoint was all-cause mortality. Baseline and follow-up data benicar online pharmacy from 2247 patients were analysable. 1516 patients with first ICD implantation (ICD group) and 731 patients without ICD serving as controls.

Multivariable models and propensity scoring for adjustment were used to compare the two groups for mortality. Adjusted mortality associated with ICD benicar online pharmacy vs. Control was significantly lower (hazard ratio 0.731). Subgroup analyses indicated no ICD benefit in diabetics or in those aged ≥75 years.

Figure 2Secondary efficacy endpoints comparing cardiosphere-derived cells and benicar online pharmacy placebo at 6 months. Change in (A) left ventricular end-diastolic volume. (B) left ventricular end-systolic volume benicar online pharmacy. And (C) N-terminal pro b-type natriuretic peptide levels.

At 6 months. CDC, cardiosphere-derived benicar online pharmacy cell. LVEDV, left ventricular end-diastolic volume. LVESV, left ventricular end-systolic volume.

NT-proBNP, N-terminal pro b-type natriuretic peptide (from Makkar RR, Kereiakes DJ, Aguirre F, Kowalchuk G, Chakravarty T, Malliaras K, Francis GS, Povsic TJ, Schatz R, Traverse JH, Pogoda JM, Smith RR, benicar online pharmacy Marbán L, Ascheim DD, Ostovaneh MR, Lima JAC, DeMaria A, Marbán E, Henry TD. Intracoronary ALLogeneic heart STem cells to Achieve myocardial Regeneration (ALLSTAR). A randomized, placebo-controlled, double-blinded trial. See pages 3451--3458).Figure 2Secondary efficacy benicar online pharmacy endpoints comparing cardiosphere-derived cells and placebo at 6 months.

Change in (A) left ventricular end-diastolic volume. (B) left benicar online pharmacy ventricular end-systolic volume. And (C) N-terminal pro b-type natriuretic peptide levels. At 6 months.

CDC, cardiosphere-derived benicar online pharmacy cell. LVEDV, left ventricular end-diastolic volume. LVESV, left ventricular end-systolic volume. NT-proBNP, N-terminal pro b-type natriuretic peptide (from Makkar RR, Kereiakes DJ, benicar online pharmacy Aguirre F, Kowalchuk G, Chakravarty T, Malliaras K, Francis GS, Povsic TJ, Schatz R, Traverse JH, Pogoda JM, Smith RR, Marbán L, Ascheim DD, Ostovaneh MR, Lima JAC, DeMaria A, Marbán E, Henry TD.

Intracoronary ALLogeneic heart STem cells to Achieve myocardial Regeneration (ALLSTAR). A randomized, placebo-controlled, double-blinded trial. See pages 3451--3458).The authors conclude that in contemporary ischaemic/dilated cardiomyopathy patients (LVEF ≤35%, narrow QRS), primary prophylactic ICD treatment benicar online pharmacy was associated with a substantial reduction in mortality, although this improvement was not consistent across the whole population. The manuscript is accompanied by an Editorial by N.A.

Mark Estes III from the Heart and Vascular Institute UPMC in Pittsburgh, Pennsylvania, USA.11 The authors note that clinicians should be mindful of available risk stratification models and subgroup analyses from the benicar online pharmacy EU-CERT-ICD and other studies. It follows that the process of shared decision-making should include careful consideration of the patient’s wishes and values, with an individualized assessment of potential benefit and risks of primary prevention of sudden death by ICD implantation.Cardiosphere-derived cells (CDCs) are cardiac progenitor cells which exhibit disease-modifying bioactivity in various models of cardiomyopathy and in previous clinical studies of acute myocardial infarction (MI), dilated cardiomyopathy, and Duchenne muscular dystrophy.12,13 In a clinical research article entitled ‘Intracoronary ALLogeneic heart STem cells to Achieve myocardial Regeneration (ALLSTAR). A randomized, placebo-controlled, double-blinded trial’, Raj Makkar from the Cedars-Sinai Heart Institute in Los Angeles, California, USA and colleagues assessed the safety and efficacy of intracoronary administration of allogeneic CDCs in the multicentre, randomized, double-blind, placebo-controlled, intracoronary ALLogeneic Heart STem Cells to Achieve Myocardial Regeneration (ALLSTAR) trial.14 The authors enrolled patients 4 weeks to 12 months after MI, with LVEF ≤45% and left ventricular LV scar size ≥15% of LVM by MRI. A pre-specified interim analysis benicar online pharmacy was performed when 6-month MRI data were available.

The trial was subsequently stopped due to the low probability of detecting a significant treatment effect of CDCs based on the primary endpoint. Patients were randomly allocated in a 2:1 ratio to receive CDCs or placebo in the infarct-related artery by the stop–flow technique. The primary safety endpoint was the occurrence, during 1-month post-intracoronary infusion, of acute myocarditis attributable to allogeneic CDCs, ventricular tachycardia- or ventricular fibrillation-related death, benicar online pharmacy sudden unexpected death, or a major adverse cardiac event (death or hospitalization for HF or non-fatal MI). The primary efficacy endpoint was the relative percentage change in infarct size at 12 months post-infusion as assessed by contrast-enhanced cardiac MRI.

Makkar and colleagues randomly allocated 90 benicar online pharmacy patients to the CDC group and 44 to the placebo group. The mean baseline LVEF was 40% and the mean scar size was 22% of the LVM. No primary safety endpoint events occurred. There was no difference in the percentage change from baseline in scar size between CDC and placebo groups at 6 benicar online pharmacy months.

Compared with placebo, there were significant reductions in LV end-diastolic volume, LV end-systolic volume, and NT-proBNP at 6 months in CDC-treated patients.The authors conclude that intracoronary infusion of allogeneic CDCs in patients with post-MI left ventricular dysfunction was safe but did not reduce scar size relative to placebo at 6 months. The manuscript is accompanied by an Editorial by Francisco Fernandez-Aviles from the Hospital General Universitario Gregorio Marañón in Madrid, Spain and colleagues.15 The authors feel that various points need to be better addressed before proceeding again to clinical trials, if we want to move the field of cardiovascular regenerative and reparative medicine forward, for the sake of the cardiovascular health of millions of patients.Treatment of pathological cardiac remodelling and subsequent HF represents an unmet clinical need. Long non-coding RNAs (lncRNAs) are emerging as crucial molecular orchestrators of disease processes including that of heart diseases.16,17 In a Basic Science article entitled ‘Targeting muscle-enriched long non-coding RNA H19 reverses pathological benicar online pharmacy cardiac hypertrophy’, Thomas Thum from the Hannover Medical School in Germany, and colleagues report on the powerful therapeutic potential of the conserved lncRNA H19 in the treatment of pathological cardiac hypertrophy.18 Pressure overload-induced left ventricular cardiac remodelling revealed an up-regulation of H19 in the early phase, but a strong sustained repression upon reaching the decompensated phase of HF. The translational potential of H19 was highlighted by its repression in a large animal (pig) model of LVH, in diseased human heart samples, in human stem cell-derived cardiomyocytes, and in human engineered heart tissue in response to afterload enhancement.

Pressure overload-induced cardiac hypertrophy in H19 knockout mice was aggravated compared with wild-type mice. In contrast, vector-based, cardiomyocyte-directed gene therapy using murine but also benicar online pharmacy human H19 strongly attenuated HF even when cardiac hypertrophy was already established. Mechanistically, using microarray, gene set enrichment analyses, and chromatin immunoprecipitation-DNA sequencing, the authors identified a link between H19 and prohypertrophic nuclear factor of activated T cells (NFAT) signalling. H19 physically interacts with the polycomb repressive complex 2 to suppress H3K27 benicar online pharmacy tri-methylation of the antihypertrophic Tescalcin locus which in turn leads to reduced NFAT expression and activity.Thum and colleagues conclude that H19 is highly conserved and down-regulated in failing hearts from mice, pigs, and humans.

H19 gene therapy prevents and reverses experimental pressure overload-induced HF. H19 acts as an antihypertrophic lncRNA and represents a promising therapeutic target to combat pathological cardiac remodelling. The manuscript is accompanied by an Editorial by Gianluigi benicar online pharmacy Condorelli from the Humanitas University in Rozzano, Italy and colleagues. The authors note that dysregulation of epigenetic mechanisms leading to aberrant loss of cardiomyocyte homeostasis is a critical point to consider in understanding the onset of cardiovascular pathologies.

Thus exploiting lncRNAs as therapeutic agents in myocardial disease could pave the way for efficaciously combatting one of the greatest healthcare burdens worldwide.19With the advent of omics, an innovative inductive method has provided researchers with possible ways new to monitor health and disease. This approach incorporates data benicar online pharmacy from studies of the genome, transcriptome, proteome, and metabolome to focus on the assessment of a varied range of biomolecules.20 In a clinical review article entitled ‘Omics phenotyping in heart failure. The next frontier’ Antoni Bayes-Genis from the Cardiology Service, Hospital Universitari Germans Trias i Pujol in Badalona, Spain and colleagues provide a state-of-the-art review aiming to provide an up-to-date look at breakthrough omic technologies that are helping to unravel HF disease mechanisms and heterogeneity.21 Genomics, transcriptomics, proteomics, and metabolomics in HF are reviewed in depth. In addition, there is a thorough, expert discussion regarding the value of omics in identifying novel disease pathways, advancing understanding of disease mechanisms, differentiating HF phenotypes, yielding biomarkers for diagnosis or prognosis, or identifying new therapeutic targets in HF.

The combination of multiple omics technologies may create a more comprehensive picture of the factors and pathophysiology involved in HF than achieved by either one alone, and provides a rich resource for predictive benicar online pharmacy phenotype modelling. However, the successful translation of omics tools as solutions to clinical HF requires that the observations are robust and reproducible, and can be validated across multiple independent populations to ensure confidence in clinical decision-making.This issue is also complemented by a Discussion Forum contribution. In a contribution benicar online pharmacy entitled ‘Heart failure development in obesity. Mechanistic pathways’ Kristjan Karason from the Sahlgrenska University Hospital in Gothenburg, Sweden and colleagues provide a reply to a recent comment entitled ‘Incident heart failure risk after bariatric surgery.

The role of epicardial fat’.22,23The editors hope that this issue of the European Heart Journal will be of interest to its readers.With thanks to Amelia Meier-Batschelet, Johanna Hugger, and Martin Meyer for help with compilation of this article. References1Docherty KF, Jhund PS, Inzucchi SE, Køber L, Kosiborod MN, Martinez FA, Ponikowski P, DeMets DL, Sabatine benicar online pharmacy MS, Bengtsson O, Sjöstrand M, Langkilde AM, Desai AS, Diez M, Howlett JG, Katova T, Ljungman CEA, O’Meara E, Petrie MC, Schou M, Verma S, Vinh PN, Solomon SD, McMurray JJV. Effects of dapagliflozin in DAPA-HF according to background heart failure therapy. Eur Heart J 2020;41:2379–2392.2Ponikowski P, Voors AA,, Anker SD, Bueno H, Cleland JGF, Coats AJS, Falk V, González-Juanatey JR, Harjola VP, Jankowska EA, Jessup M, Linde C, Nihoyannopoulos P, Parissis JT, Pieske B, Riley JP, Rosano GMC, Ruilope LM, Ruschitzka F, Rutten FH, van der Meer P.

2016 ESC Guidelines for the diagnosis and treatment of acute and benicar online pharmacy chronic heart failure. The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC). Developed with the special contribution of the Heart benicar online pharmacy Failure Association (HFA) of the ESC. Eur Heart J 2016;37:2129–2200.3Packer M.

Are the benefits of SGLT2 inhibitors in heart failure and a reduced ejection fraction influenced by background therapy?. Expectations and realities of a new benicar online pharmacy standard of care. Eur Heart J 2020;41:2393–2396.4Butler J, Zannad F, Filippatos G, Anker SD, Packer M. Totality of evidence in trials of sodium–glucose co-transporter-2 inhibitors in the patients with heart failure with reduced ejection fraction.

Implications for benicar online pharmacy clinical practice. Eur Heart J 2020;41:3398–3401.5Serenelli M, Böhm M, Inzucchi SE, Køber L, Kosiborod MN, Martinez FA, Ponikowski P,, Sabatine MS, Solomon SD, DeMets DL, Bengtsson O, Sjöstrand M, Langkilde AM, Anand IS, Chiang CE, Chopra VK, de Boer RA, Diez M, Dukát A, Ge J, Howlett JG, Katova T, Kitakaze M, Ljungman CEA, Verma S,, Docherty KF, Jhund PS, McMurray JJV. Effect of dapagliflozin according to baseline systolic blood pressure in the Dapagliflozin and Prevention of Adverse Outcomes in Heart Failure trial (DAPA-HF). Eur Heart J 2020;41:3402–3418.6Savarese benicar online pharmacy G, Cosentino F.

The interaction between dapagliflozin and blood pressure in heart failure. New evidence dissipating concerns benicar online pharmacy. Eur Heart J 2020;41:3419–3420.7Brown AJM, Gandy S, McCrimmon R, Houston JG, Struthers AD, Lang CC. A randomized controlled trial of dapagliflozin on left ventricular hypertrophy in people with type two diabetes.

The DAPA-LVH trial benicar online pharmacy. Eur Heart J 2020;41:3421–3432.8Paneni F, Costantino S, Hamdani N. Regression of left ventricular hypertrophy with SGLT2 inhibitors. Eur Heart J 2020;41:3433–3436.9Priori SG, Blomström-Lundqvist C, Mazzanti A, Blom N, Borggrefe M, Camm J, Elliott PM, Fitzsimons D, Hatala R, Hindricks G, Kirchhof P, Kjeldsen K, Kuck KH, Hernandez-Madrid A, Nikolaou N, Norekvål TM, benicar online pharmacy Spaulding C, Van Veldhuisen DJ.

2015 ESC Guidelines for the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death. The Task Force for the Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death of the benicar online pharmacy European Society of Cardiology (ESC). Endorsed by. Association for European Paediatric and Congenital Cardiology (AEPC).

Eur Heart J 2015;36:2793–2867.10Zabel M, Willems R, Lubinski A, Bauer A, Brugada J, Conen D, Flevari P, Hasenfuß G, Svetlosak M, Huikuri HV, Malik M, Pavlović N, Schmidt G, Sritharan R, benicar online pharmacy Schlögl S, Szavits-Nossan J, Traykov V, Tuinenburg AE, Willich SN, Harden M, Friede T, Svendsen JH, Sticherling C, Merkely B. Clinical effectiveness of primary prevention implantable cardioverter-defibrillators. Results of the EU-CERT-ICD controlled multicentre cohort study. Eur Heart J 2020;41:3437–3447.11Estes MNA, benicar online pharmacy Saba S.

Primary prevention of sudden death with the implantable cardioverter defibrillator. Bridging the evidence gap. Eur Heart J 2020;41:3448–3450.12Aminzadeh MA, Tseliou E, Sun B, Cheng K, Malliaras K, Makkar RR, benicar online pharmacy Marbán E. Therapeutic efficacy of cardiosphere-derived cells in a transgenic mouse model of non-ischaemic dilated cardiomyopathy.

Eur Heart J 2015;36:751–762.13Fadini GP, benicar online pharmacy Mehta A, Dhindsa DS, Bonora BM, Sreejit G, Nagareddy P, Quyyumi AA. Circulating stem cells and cardiovascular outcomes. From basic science to the clinic. Eur Heart benicar online pharmacy J 2020.

Doi:10.1093/eurheartj/ehz923.14Makkar RR, Kereiakes DJ, Aguirre F, Kowalchuk G, Chakravarty T, Malliaras K, Francis GS, Povsic TJ, Schatz R, Traverse JH, Pogoda JM, Smith RR, Marbán L, Ascheim DD, Ostovaneh MR, Lima JAC, DeMaria A, Marbán E, Henry TD. Intracoronary ALLogeneic heart STem cells to Achieve myocardial Regeneration (ALLSTAR). A randomized, placebo-controlled, double-blinded trial benicar online pharmacy. Eur Heart J 2020;41:3451–3458.15Sanz-Ruiz R, Fernández-Avilés F.

Cardiovascular regenerative and reparative medicine. Is myocardial infarction the benicar online pharmacy model?. Eur Heart J 2020;41:3459–3461.16Ounzain S, Micheletti R, Beckmann T, Schroen B, Alexanian M, Pezzuto I, Crippa S, Nemir M, Sarre A, Johnson R, Dauvillier J, Burdet F, Ibberson M, Guigó R, Xenarios I, Heymans S, Pedrazzini T. Genome-wide profiling of the benicar online pharmacy cardiac transcriptome after myocardial infarction identifies novel heart-specific long non-coding RNAs.

Eur Heart J 2015;36:353–368.17Lüscher TF. Novel molecular mechanisms of vascular disease. Non-coding RNAs, benicar online pharmacy inflammation, and radiation. Eur Heart J.

2020;40:2467–2470.18Viereck J, Bührke A, Foinquinos A, Chatterjee S, Kleeberger JA, Xiao K, Janssen-Peters H, Batkai S, Ramanujam D, Kraft T, Cebotari S, Gueler F, Beyer AM, Schmitz J, Bräsen JH, Schmitto JD, Gyöngyösi M, Löser A, Hirt MN, Eschenhagen T, Engelhardt S, Bär C, Thum T. Targeting muscle-enriched long non-coding RNA H19 benicar online pharmacy reverses pathological cardiac hypertrophy. Eur Heart J 2020;41:3462–3474.19Pagiatakis C, Hall IF, Condorelli G. Long non-coding RNA benicar online pharmacy H19.

A new avenue for RNA therapeutics in cardiac hypertrophy?. Eur Heart J 2020;41:3475–3476.20Hoogeveen RM, Pereira JPB, Nurmohamed NS, Zampoleri V, Bom MJ, Baragetti A, Boekholdt SM, Knaapen P, Khaw KT, Wareham NJ, Groen AK, Catapano AL, Koenig W, Levin E, Stroes ESG. Improved cardiovascular risk prediction using targeted plasma proteomics in primary prevention benicar online pharmacy. Eur Heart J 2020;ehaa648.

21Bayes-Genis A, Liu PP, Lanfear DE, de Boer RA, González A, Thum T, Emdin M, Januzzi JL. Omics phenotyping in heart failure benicar online pharmacy. The next frontier. Eur Heart J 2020;41:3477–3484.22Karason K, Jamaly S.

Heart failure development benicar online pharmacy in obesity. Mechanistic pathways. Eur Heart J benicar online pharmacy 2020;41:3485.23van Woerden G, van Veldhuisen SL, Rienstra M. Incident heart failure risk after bariatric surgery.

The role of epicardial fat. Eur Heart benicar online pharmacy J 2020;41:1775. Published on behalf of the European Society of Cardiology. All rights reserved.

© The Author(s) 2020. For permissions, please email. Journals.permissions@oup.com..

Benicar mdl settlement

Latest Pregnancy News benicar mdl settlement FRIDAY, Oct. 16, 2020 (HealthDay News) -- A series of studies show that preterm births have decreased during lockdowns to control the coronavirus pandemic, and researchers are trying to determine why.A large study from the Netherlands found that preterm births fell 15-23% after March 9, when the government started urging people to follow more social distancing measures and to stay home if they had symptoms or possible benicar mdl settlement exposures to the virus. Within the next week, schools and workplaces began to close down, The New York Times reported.The study was published Oct. 13 in The Lancet Public Health medical journal.Two studies from Ireland and Denmark found that declines in preterm births in the spring during lockdowns, and benicar mdl settlement there are anecdotal reports from doctors worldwide about decreases in preterm births, The Times reported.Some experts suggest that better hygiene, cleaner air and reduced stress on mothers during lockdowns may be factors in falling preterm birth rates.Copyright © 2019 HealthDay. All rights reserved.

SLIDESHOW Conception benicar mdl settlement. The Amazing Journey from Egg to Embryo See SlideshowLatest Coronavirus News By Robin Foster and E.J. MundellHealthDay ReportersFRIDAY, benicar mdl settlement Oct. 16, 2020 benicar mdl settlement (HealthDay News)The number of new U.S. Coronavirus cases topped 60,000 on Thursday, a tally not reported since early August, as health experts worried the coming winter might push the toll even higher.The latest numbers have also sent the country's total COVID-19 case count past 8 million, the The New York Times reported.The surge is nationwide, with cases multiplying across the country.

Forty-four states benicar mdl settlement and the District of Columbia have higher caseloads now than in mid-September, and the new coronavirus is spreading across rural communities in the Midwest, the Upper Midwest and the Great Plains, the Washington Post reported.On Thursday, Wisconsin set a record with more than 4,000 new cases reported, the newspaper said. Illinois also reported more than 4,000 cases on Thursday, breaking records that were set in April and May. Ohio set a new high, as did Indiana, New Mexico, North Dakota, Montana and Colorado, the Post reported."We know that this is going to get worse benicar mdl settlement before it gets better," Wisconsin Department of Health Services secretary-designee Andrea Palm said during a briefing Thursday, the Post reported. "Stay home. Wear a benicar mdl settlement mask.

Stay six feet apart. Wash your hands frequently."Some hospitals in benicar mdl settlement the Upper Midwest and Great Plains have become jammed with patients and are running low on ICU beds, the Post reported. Montana reported a record 301 hospitalized COVID-19 patients Thursday, with 98 percent of the inpatient beds occupied the day before in Yellowstone County.In just the past week, at least 20 states have set record seven-day averages for infections, and a dozen have hit record hospitalization benicar mdl settlement rates, according to health department data analyzed by the Post.The reopening of many schools and colleges did not fuel a major spike in cases right away, as some experts had feared, but the numbers have steadily gone upward since, the newspaper reported.The jump in cases and hospitalizations has been followed by a more modest rise in COVID-19 deaths, most likely due to better patient care from now-seasoned medical workers. The widespread use of powerful steroids and other treatments has lowered mortality rates among people who are severely ill, the Post reported.Still, experts caution that most Americans remain vulnerable to COVID infection and the virus will likely spread more easily as colder weather sends more people indoors, where they might be exposed to larger amounts of the virus in poorly ventilated spaces."Inevitably, we're moving into a phase where there's going to need to be restrictions again," David Rubin, director of PolicyLab at Children's Hospital of Philadelphia, told the Post.Second COVID vaccine trial pausedA second coronavirus vaccine trial has been paused after an unexplained illness surfaced in one of the trial's volunteers.Johnson &. Johnson, which only began a phase 3 trial benicar mdl settlement of its vaccine last month, did not offer any more details on the illness and did not say whether the sick participant had received the vaccine or a placebo.

The trial pause was first reported by the health news website STAT.While Johnson &. Johnson was behind several of its competitors in the vaccine race, its candidate has an advantage in that benicar mdl settlement it doesn't need to be frozen and it could be given in one dose instead of two, the Times reported. The J&J vaccine is also the focus of the largest COVID-19 vaccine trial, with a goal of enrolling 60,000 volunteers."Adverse events -- illnesses, accidents, etc. -- even those that are serious, are an expected part of any clinical study, especially large studies," benicar mdl settlement the company said in a statement. "We're also learning more about this participant's illness, and it's important to have all the facts before we share additional information.""It's actually a good thing that these companies are pausing these trials when these things come up," Dr.

Phyllis Tien, an infectious disease physician at the University benicar mdl settlement of California, San Francisco, a vaccine trial site for both Johnson &. Johnson and AstraZeneca, told the benicar mdl settlement Times. "We just need to let the sponsor and the safety board do their review and let us know their findings."Johnson &. Johnson is not the first company benicar mdl settlement to pause a coronavirus vaccine trial. Two participants in AstraZeneca's trial became seriously ill after getting its vaccine.

That trial has been benicar mdl settlement halted and has not yet resumed in the United States.Two companies working on antibody cocktailsRegeneron Pharmaceuticals Inc. Said last week that it is seeking emergency approval from the U.S. Food and Drug Administration for an experimental antibody cocktail given to Trump shortly after he was diagnosed with COVID-19.Hours before the company made the announcement, Trump proclaimed in a video released by the White House that the drug had an "unbelievable" effect on benicar mdl settlement his recovery from coronavirus infection, the Post reported. While there is no hard evidence yet proving the drug's effectiveness in humans, it has shown promise in treating mild cases of the new coronavirus, the Post reported.Regeneron said in its statement that it could initially produce doses of the antibody cocktail for 50,000 patients, and then ramp production up to doses for 300,000 patients in the next few months if granted emergency authorization.The U.S. Government first inked a contract with Regeneron back in July, and has promised to distribute initial doses of the treatment at no cost if it is benicar mdl settlement approved, the Post reported.

Regeneron isn't benicar mdl settlement the only company developing an antibody cocktail to battle COVID-19 infection. Eli Lilly and Co. Has also announced that it is seeking emergency use authorization from the FDA for benicar mdl settlement a similar cocktail. But on Tuesday, the company announced it has paused a trial of its antibody cocktail for safety concerns and did not divulge any further details about the reason for the pause, the Post reported.COVID continues to spread around the globeBy Friday, the U.S. Coronavirus case count passed 8 million while the death toll passed 217,500, according to a Times tally.According to the same tally, the top five states in coronavirus cases as benicar mdl settlement of Friday were.

California with over 870,000. Texas with more than benicar mdl settlement 853,500. Florida with benicar mdl settlement nearly 745,000. New York with over 484,000. And Illinois with more than 336,000.Curbing the spread of the coronavirus in the rest of the world remains challenging.Several European countries are experiencing case surges as they struggle with a second wave of coronavirus infections and hospital beds begin to fill up, the Post reported.In benicar mdl settlement England, Prime Minister Boris Johnson has instituted a three-tier lockdown in a bid to slow a startling spike in coronavirus cases across the country.

In the past three weeks, new coronavirus cases have quadrupled and there are now more COVID-19 patients hospitalized than before the government imposed a lockdown back in March, the Post reported.Addressing the nation this week, Johnson warned Britons that the country's rise in cases was "flashing like dashboard warnings in a passenger jet."Things are no better in India, where the coronavirus case count has passed 7.3 million, a Johns Hopkins tally showed.More than 112,000 coronavirus patients have died in India, according to the Hopkins tally, but when measured as a proportion of the population, the country has had far fewer deaths than many others. Doctors say this reflects benicar mdl settlement India's younger and leaner population.Still, the country's public health system is severely strained, and some sick patients cannot find hospital beds, the Times said. Only the United States has more coronavirus cases.Meanwhile, Brazil passed 5.1 million cases and had over 152,000 deaths as of Friday, the Hopkins tally showed.Cases are also spiking in Russia. The country's coronavirus case count has passed 1.3 million benicar mdl settlement. As of Friday, the reported death toll in Russia was over 23,500, the Hopkins tally showed.Worldwide, the number of reported infections passed 38.9 million on Friday, with nearly 1.1 million deaths, according to the Hopkins tally.Copyright © 2020 HealthDay.

All rights benicar mdl settlement reserved. References benicar mdl settlement SOURCES. The New York Times. Washington Post benicar mdl settlement. Associated Press.

Oct. 7, 2020, statement, Regeneron Pharmaceuticals Inc.Latest Prevention &. Wellness News FRIDAY, Oct. 16, 2020 (HealthDay News)An experimental COVID-19 vaccine appeared to be safe and triggered an immune response in healthy people, according to preliminary results of a small, early-stage clinical trial.The study of the vaccine based on inactivated whole SARS-CoV-2 virus (BBIBP-CorV) included more than 600 volunteers in China, ages 18 to 80. By the 42nd day after vaccination, all had antibody responses to the virus, according to researchers.The vaccine was safe and well-tolerated at all doses tested, study leaders reported.

The most common side effect was pain at the injection site. There were no serious adverse reactions.The findings were published Oct. 15 in The Lancet Infectious Diseases journal.Similar results were reported from a previous trial for a different vaccine also based on inactivated whole SARS-CoV-2 virus. That trial was limited to people under age 60.The new trial found that people 60 and older responded more slowly to the vaccine. It took 42 days for antibodies to be detected in all of them, compared to 28 days among 18- to 59-year-olds.Antibody levels were also lower in 60- to 80-year-olds compared with the younger volunteers."Protecting older people is a key aim of a successful COVID-19 vaccine as this age group is at greater risk of severe illness from the disease.

However, vaccines are sometimes less effective in this group because the immune system weakens with age," said study co-author Xiaoming Yang, a professor at Beijing Institute of Biological Products Company Limited."It is therefore encouraging to see that BBIBP-CorV induces antibody responses in people aged 60 and older, and we believe this justifies further investigation," Yang said in a journal news release.Because the trial wasn't designed to assess the effectiveness of the BBIBP-CorV vaccine, it's not possible to know whether the antibody response it triggered is strong enough to protect people from infection with the new coronavirus.After the researchers complete a full analysis of data from the adults, they plan to test the vaccine in children and teens under age 18.Larisa Rudenko, a researcher at the Institute of Experimental Medicine in St. Petersburg, Russia, wrote an editorial that accompanied the findings.She said more "studies are needed to establish whether the inactivated SARS-CoV-2 vaccines are capable of inducing and maintaining virus-specific T-cell responses."-- Robert PreidtCopyright © 2020 HealthDay. All rights reserved. SLIDESHOW Whooping Cough (Pertussis) Symptoms, Vaccine Facts See Slideshow References SOURCE. The Lancet Infectious Diseases, news release, Oct.

15, 2020Latest Heart News FRIDAY, Oct. 16, 2020In what will come as reassuring news to those who were born with a heart defect, new research finds these people aren't at increased risk for moderate or severe COVID-19.The study included more than 7,000 adults and children who were born with a heart defect (congenital heart disease) and followed by researchers at Columbia University Vagelos College of Physicians and Surgeons, in New York City.Between March and July 2020, the center reported 53 congenital heart disease patients (median age 34) with COVID-19 infection."At the beginning of the pandemic, many feared that congenital heart disease would be as big a risk factor for COVID-19 as adult-onset cardiovascular disease," the study authors wrote in the report published online Oct. 14 in the Journal of the American Heart Association.However, the researchers were "reassured by the low number of patients treated at their center and the patients' outcomes," they said in a journal news release.Among the 43 adults and 10 children with a congenital heart defect who were infected with COVID-19, 58% had complex congenital anatomy, 15% had a genetic syndrome, 11% had pulmonary hypertension and 17% were obese.Nine patients (17%) had a moderate/severe infection, and three patients (6%) died, according to the study.A concurrent genetic syndrome in patients of all ages and advanced physiologic stage in adult patients were each associated with an increased risk of COVID-19 symptom severity, the findings showed.Five patients had trisomy 21 (an extra chromosome at position 21), four patients had Eisenmenger's syndrome (abnormal blood circulation caused by structural defects in the heart) and two patients had DiGeorge syndrome (a condition caused by the deletion of a segment of chromosome 22). Nearly all patients with trisomy 21 and DiGeorge syndrome had moderate/severe COVID-19 symptoms."While our sample size is small, these results imply that specific congenital heart lesions may not be sufficient cause alone for severe COVID-19 infection," according to Dr. Matthew Lewis, of Columbia University Irving Medical Center, and his colleagues."Despite evidence that adult-onset cardiovascular disease is a risk factor for worse outcomes among patients with COVID-19, patients with [congenital heart disease] without concomitant genetic syndrome, and adults who are not at advanced physiological stage, do not appear to be disproportionately impacted," the study authors concluded.-- Robert PreidtCopyright © 2020 HealthDay.

All rights reserved. SLIDESHOW Heart Disease. Causes of a Heart Attack See Slideshow References SOURCE. Journal of the American Heart Association, news release, Oct. 14, 2020Latest Coronavirus News FRIDAY, Oct.

16, 2020 (HealthDay News) -- An elderly woman in the Netherlands died after contracting COVID-19 a second time, which researchers say may be the world's first known death after reinfection.The woman was being treated for cancer when she developed a fever and severe cough and was diagnosed with COVID-19. She went home five days later and, other than lingering fatigue, recovered from her symptoms, CBS News reported.But 59 days after the start of her first COVID-19 infection, she developed symptoms again. She tested positive for COVID-19 again and died weeks later, according to the case study accepted for publication in the journal Clinical Infectious Diseases.The woman was infected with two different strains and it is unclear if she ever became immune following each infection, according to the researchers, who said "it is likely that the second episode was a reinfection rather than prolonged shedding," CBS News reported.There have been other reported cases of coronavirus reinfection. For example, a 25-year-old man in Nevada was infected twice by two different strains. His second infection was more severe than the first and lasted about six weeks, researchers recently reported in the The Lancet Infectious Diseases journal.COVID-19 reinfection also occurred in a patient in Hong Kong, CBS News reported.Copyright © 2019 HealthDay.

Latest Pregnancy benicar online pharmacy News FRIDAY, Oct. 16, 2020 (HealthDay News) -- A series of studies show that preterm births have decreased during lockdowns to control the coronavirus pandemic, and researchers are trying to determine why.A large study benicar online pharmacy from the Netherlands found that preterm births fell 15-23% after March 9, when the government started urging people to follow more social distancing measures and to stay home if they had symptoms or possible exposures to the virus. Within the next week, schools and workplaces began to close down, The New York Times reported.The study was published Oct. 13 in The Lancet Public Health medical journal.Two studies from Ireland and Denmark found that benicar online pharmacy declines in preterm births in the spring during lockdowns, and there are anecdotal reports from doctors worldwide about decreases in preterm births, The Times reported.Some experts suggest that better hygiene, cleaner air and reduced stress on mothers during lockdowns may be factors in falling preterm birth rates.Copyright © 2019 HealthDay. All rights reserved.

SLIDESHOW Conception benicar online pharmacy. The Amazing Journey from Egg to Embryo See SlideshowLatest Coronavirus News By Robin Foster and E.J. MundellHealthDay ReportersFRIDAY, Oct benicar online pharmacy. 16, 2020 (HealthDay News)The number of new U.S benicar online pharmacy. Coronavirus cases topped 60,000 on Thursday, a tally not reported since early August, as health experts worried the coming winter might push the toll even higher.The latest numbers have also sent the country's total COVID-19 case count past 8 million, the The New York Times reported.The surge is nationwide, with cases multiplying across the country.

Forty-four states and the District of benicar online pharmacy Columbia have higher caseloads now than in mid-September, and the new coronavirus is spreading across rural communities in the Midwest, the Upper Midwest and the Great Plains, the Washington Post reported.On Thursday, Wisconsin set a record with more than 4,000 new cases reported, the newspaper said. Illinois also reported more than 4,000 cases on Thursday, breaking records that were set in April and May. Ohio set a new high, as did Indiana, New Mexico, North Dakota, Montana and Colorado, the Post benicar online pharmacy reported."We know that this is going to get worse before it gets better," Wisconsin Department of Health Services secretary-designee Andrea Palm said during a briefing Thursday, the Post reported. "Stay home. Wear a mask benicar online pharmacy.

Stay six feet apart. Wash your hands frequently."Some hospitals in the Upper Midwest and Great Plains have become jammed with patients and are benicar online pharmacy running low on ICU beds, the Post reported. Montana reported a record 301 hospitalized COVID-19 patients Thursday, with 98 percent of the inpatient beds occupied the day before in Yellowstone County.In just the past week, at least 20 states have set record seven-day averages for infections, and a dozen have hit record hospitalization benicar online pharmacy rates, according to health department data analyzed by the Post.The reopening of many schools and colleges did not fuel a major spike in cases right away, as some experts had feared, but the numbers have steadily gone upward since, the newspaper reported.The jump in cases and hospitalizations has been followed by a more modest rise in COVID-19 deaths, most likely due to better patient care from now-seasoned medical workers. The widespread use of powerful steroids and other treatments has lowered mortality rates among people who are severely ill, the Post reported.Still, experts caution that most Americans remain vulnerable to COVID infection and the virus will likely spread more easily as colder weather sends more people indoors, where they might be exposed to larger amounts of the virus in poorly ventilated spaces."Inevitably, we're moving into a phase where there's going to need to be restrictions again," David Rubin, director of PolicyLab at Children's Hospital of Philadelphia, told the Post.Second COVID vaccine trial pausedA second coronavirus vaccine trial has been paused after an unexplained illness surfaced in one of the trial's volunteers.Johnson &. Johnson, which only began a phase 3 trial of its vaccine last month, did not offer benicar online pharmacy any more details on the illness and did not say whether the sick participant had received the vaccine or a placebo.

The trial pause was first reported by the health news website STAT.While Johnson &. Johnson was behind several of its competitors in the vaccine race, its candidate has an benicar online pharmacy advantage in that it doesn't need to be frozen and it could be given in one dose instead of two, the Times reported. The J&J vaccine is also the focus of the largest COVID-19 vaccine trial, with a goal of enrolling 60,000 volunteers."Adverse events -- illnesses, accidents, etc. -- even those that are serious, are an expected part of any clinical study, benicar online pharmacy especially large studies," the company said in a statement. "We're also learning more about this participant's illness, and it's important to have all the facts before we share additional information.""It's actually a good thing that these companies are pausing these trials when these things come up," Dr.

Phyllis Tien, an infectious disease physician at the University of California, San Francisco, a vaccine trial site for both Johnson benicar online pharmacy &. Johnson and AstraZeneca, told benicar online pharmacy the Times. "We just need to let the sponsor and the safety board do their review and let us know their findings."Johnson &. Johnson is not the first company to pause benicar online pharmacy a coronavirus vaccine trial. Two participants in AstraZeneca's trial became seriously ill after getting its vaccine.

That trial has been halted and has not yet resumed in the United States.Two companies working on antibody cocktailsRegeneron Pharmaceuticals Inc benicar online pharmacy. Said last week that it is seeking emergency approval from the U.S. Food and Drug Administration for an experimental antibody cocktail given benicar online pharmacy to Trump shortly after he was diagnosed with COVID-19.Hours before the company made the announcement, Trump proclaimed in a video released by the White House that the drug had an "unbelievable" effect on his recovery from coronavirus infection, the Post reported. While there is no hard evidence yet proving the drug's effectiveness in humans, it has shown promise in treating mild cases of the new coronavirus, the Post reported.Regeneron said in its statement that it could initially produce doses of the antibody cocktail for 50,000 patients, and then ramp production up to doses for 300,000 patients in the next few months if granted emergency authorization.The U.S. Government first benicar online pharmacy inked a contract with Regeneron back in July, and has promised to distribute initial doses of the treatment at no cost if it is approved, the Post reported.

Regeneron isn't the only company developing an antibody cocktail benicar online pharmacy to battle COVID-19 infection. Eli Lilly and Co. Has also announced that it is seeking emergency use benicar online pharmacy authorization from the FDA for a similar cocktail. But on Tuesday, the company announced it has paused a trial of its antibody cocktail for safety concerns and did not divulge any further details about the reason for the pause, the Post reported.COVID continues to spread around the globeBy Friday, the U.S. Coronavirus case count passed 8 million while the death toll passed 217,500, according to a Times tally.According to the same tally, the top five states in coronavirus cases as of Friday were benicar online pharmacy.

California with over 870,000. Texas with more than benicar online pharmacy 853,500. Florida with benicar online pharmacy nearly 745,000. New York with over 484,000. And Illinois with more than 336,000.Curbing the spread of the coronavirus in the rest of the world remains challenging.Several European countries are experiencing case surges as they struggle with a second wave of coronavirus infections and hospital beds begin to fill up, the Post reported.In England, Prime Minister Boris Johnson has instituted a three-tier lockdown in a bid to slow benicar online pharmacy a startling spike in coronavirus cases across the country.

In the past three weeks, new coronavirus cases have quadrupled and there are now more COVID-19 patients hospitalized than before the government imposed a lockdown back in March, the Post reported.Addressing the nation this week, Johnson warned Britons that the country's rise in cases was "flashing like dashboard warnings in a passenger jet."Things are no better in India, where the coronavirus case count has passed 7.3 million, a Johns Hopkins tally showed.More than 112,000 coronavirus patients have died in India, according to the Hopkins tally, but when measured as a proportion of the population, the country has had far fewer deaths than many others. Doctors say this reflects India's younger and leaner population.Still, the country's benicar online pharmacy public health system is severely strained, and some sick patients cannot find hospital beds, the Times said. Only the United States has more coronavirus cases.Meanwhile, Brazil passed 5.1 million cases and had over 152,000 deaths as of Friday, the Hopkins tally showed.Cases are also spiking in Russia. The country's coronavirus case count has passed 1.3 million benicar online pharmacy. As of Friday, the reported death toll in Russia was over 23,500, the Hopkins tally showed.Worldwide, the number of reported infections passed 38.9 million on Friday, with nearly 1.1 million deaths, according to the Hopkins tally.Copyright © 2020 HealthDay.

All rights reserved benicar online pharmacy. References SOURCES benicar online pharmacy. The New York Times. Washington Post benicar online pharmacy. Associated Press.

Oct. 7, 2020, statement, Regeneron Pharmaceuticals Inc.Latest Prevention &. Wellness News FRIDAY, Oct. 16, 2020 (HealthDay News)An experimental COVID-19 vaccine appeared to be safe and triggered an immune response in healthy people, according to preliminary results of a small, early-stage clinical trial.The study of the vaccine based on inactivated whole SARS-CoV-2 virus (BBIBP-CorV) included more than 600 volunteers in China, ages 18 to 80. By the 42nd day after vaccination, all had antibody responses to the virus, according to researchers.The vaccine was safe and well-tolerated at all doses tested, study leaders reported.

The most common side effect was pain at the injection site. There were no serious adverse reactions.The findings were published Oct. 15 in The Lancet Infectious Diseases journal.Similar results were reported from a previous trial for a different vaccine also based on inactivated whole SARS-CoV-2 virus. That trial was limited to people under age 60.The new trial found that people 60 and older responded more slowly to the vaccine. It took 42 days for antibodies to be detected in all of them, compared to 28 days among 18- to 59-year-olds.Antibody levels were also lower in 60- to 80-year-olds compared with the younger volunteers."Protecting older people is a key aim of a successful COVID-19 vaccine as this age group is at greater risk of severe illness from the disease.

However, vaccines are sometimes less effective in this group because the immune system weakens with age," said study co-author Xiaoming Yang, a professor at Beijing Institute of Biological Products Company Limited."It is therefore encouraging to see that BBIBP-CorV induces antibody responses in people aged 60 and older, and we believe this justifies further investigation," Yang said in a journal news release.Because the trial wasn't designed to assess the effectiveness of the BBIBP-CorV vaccine, it's not possible to know whether the antibody response it triggered is strong enough to protect people from infection with the new coronavirus.After the researchers complete a full analysis of data from the adults, they plan to test the vaccine in children and teens under age 18.Larisa Rudenko, a researcher at the Institute of Experimental Medicine in St. Petersburg, Russia, wrote an editorial that accompanied the findings.She said more "studies are needed to establish whether the inactivated SARS-CoV-2 vaccines are capable of inducing and maintaining virus-specific T-cell responses."-- Robert PreidtCopyright © 2020 HealthDay. All rights reserved. SLIDESHOW Whooping Cough (Pertussis) Symptoms, Vaccine Facts See Slideshow References SOURCE. The Lancet Infectious Diseases, news release, Oct.

15, 2020Latest Heart News FRIDAY, Oct. 16, 2020In what will come as reassuring news to those who were born with a heart defect, new research finds these people aren't at increased risk for moderate or severe COVID-19.The study included more than 7,000 adults and children who were born with a heart defect (congenital heart disease) and followed by researchers at Columbia University Vagelos College of Physicians and Surgeons, in New York City.Between March and July 2020, the center reported 53 congenital heart disease patients (median age 34) with COVID-19 infection."At the beginning of the pandemic, many feared that congenital heart disease would be as big a risk factor for COVID-19 as adult-onset cardiovascular disease," the study authors wrote in the report published online Oct. 14 in the Journal of the American Heart Association.However, the researchers were "reassured by the low number of patients treated at their center and the patients' outcomes," they said in a journal news release.Among the 43 adults and 10 children with a congenital heart defect who were infected with COVID-19, 58% had complex congenital anatomy, 15% had a genetic syndrome, 11% had pulmonary hypertension and 17% were obese.Nine patients (17%) had a moderate/severe infection, and three patients (6%) died, according to the study.A concurrent genetic syndrome in patients of all ages and advanced physiologic stage in adult patients were each associated with an increased risk of COVID-19 symptom severity, the findings showed.Five patients had trisomy 21 (an extra chromosome at position 21), four patients had Eisenmenger's syndrome (abnormal blood circulation caused by structural defects in the heart) and two patients had DiGeorge syndrome (a condition caused by the deletion of a segment of chromosome 22). Nearly all patients with trisomy 21 and DiGeorge syndrome had moderate/severe COVID-19 symptoms."While our sample size is small, these results imply that specific congenital heart lesions may not be sufficient cause alone for severe COVID-19 infection," according to Dr. Matthew Lewis, of Columbia University Irving Medical Center, and his colleagues."Despite evidence that adult-onset cardiovascular disease is a risk factor for worse outcomes among patients with COVID-19, patients with [congenital heart disease] without concomitant genetic syndrome, and adults who are not at advanced physiological stage, do not appear to be disproportionately impacted," the study authors concluded.-- Robert PreidtCopyright © 2020 HealthDay.

All rights reserved. SLIDESHOW Heart Disease. Causes of a Heart Attack See Slideshow References SOURCE. Journal of the American Heart Association, news release, Oct. 14, 2020Latest Coronavirus News FRIDAY, Oct.

16, 2020 (HealthDay News) -- An elderly woman in the Netherlands died after contracting COVID-19 a second time, which researchers say may be the world's first known death after reinfection.The woman was being treated for cancer when she developed a fever and severe cough and was diagnosed with COVID-19. She went home five days later and, other than lingering fatigue, recovered from her symptoms, CBS News reported.But 59 days after the start of her first COVID-19 infection, she developed symptoms again. She tested positive for COVID-19 again and died weeks later, according to the case study accepted for publication in the journal Clinical Infectious Diseases.The woman was infected with two different strains and it is unclear if she ever became immune following each infection, according to the researchers, who said "it is likely that the second episode was a reinfection rather than prolonged shedding," CBS News reported.There have been other reported cases of coronavirus reinfection. For example, a 25-year-old man in Nevada was infected twice by two different strains. His second infection was more severe than the first and lasted about six weeks, researchers recently reported in the The Lancet Infectious Diseases journal.COVID-19 reinfection also occurred in a patient in Hong Kong, CBS News reported.Copyright © 2019 HealthDay.

What is the generic name of benicar

For immediate what is the generic name of benicar release. October 19, 2020Boston, MA – Air pollution was significantly associated with an increased risk of hospital what is the generic name of benicar admissions for several neurological disorders, including Parkinson’s disease, Alzheimer’s disease, and other dementias, in a long-term study of more than 63 million older U.S. Adults, led by researchers at Harvard T.H. Chan School what is the generic name of benicar of Public Health.The study, conducted with colleagues at Emory University’s Rollins School of Public Health and Columbia University’s Mailman School of Public Health, is the first nationwide analysis of the link between fine particulate (PM2.5) pollution and neurodegenerative diseases in the U.S.

The researchers leveraged an unparalleled amount of data compared to any previous study of air pollution and neurological disorders.The study was published online October 19, 2020 in The Lancet Planetary Health.“The 2020 report of the Lancet Commission on dementia prevention, intervention, and care has added air pollution as one of the modifiable risk factors for these outcomes,” said Xiao Wu, doctoral student in biostatistics at Harvard Chan School and co-lead author of the study. €œOur study what is the generic name of benicar builds on the small but emerging evidence base indicating that long-term PM2.5 exposures are linked to an increased risk of neurological health deterioration, even at PM2.5 concentrations well below the current national standards.”Researchers looked at 17 years’ worth (2000–2016) of hospital admissions data from 63,038,019 Medicare recipients in the U.S. And linked what is the generic name of benicar these with estimated PM2.5 concentrations by zip code. Taking into account potential confounding factors like socioeconomic status, they found that, for each 5 microgram per cubic meter of air (μg/m3) increase in annual PM2.5 concentrations, there was a 13% increased risk for first-time hospital admissions both for Parkinson’s disease and for Alzheimer’s disease and related dementias.

This risk remained elevated even below supposedly what is the generic name of benicar safe levels of PM2.5 exposure, which, according to current U.S. Environmental Protection Agency standards, is an annual average of 12 μg/m3 or less.Women, white people, and urban populations were particularly susceptible, the study found. The highest risk for first-time Parkinson’s disease hospital admissions was among older adults in what is the generic name of benicar the northeastern U.S. For first-time Alzheimer’s disease and related dementias hospital admissions, older adults in the Midwest faced the highest risk.“Our U.S.-wide study shows that the current standards are not protecting the aging American population enough, highlighting the need for stricter standards and policies that help further reduce PM2.5 concentrations and improve air quality overall,” said Antonella Zanobetti, principal research scientist in Harvard Chan School’s Department of Environmental Health and co-senior author of the study.Liuhua Shi, research assistant professor at Emory’s Rollins School of Public Health, was a co-lead author and Marianthi-Anna Kioumourtzoglou, assistant professor in environmental health sciences at Columbia’s Mailman School of Public Health, was a co-senior author.Other Harvard Chan School authors included Mahdieh Danesh Yazdi, Danielle Braun, Yaguang Wei, Yun Wang, Joel Schwartz, and Francesca Dominici.This study was supported by the Health Effects Institute (4953-RFA14-3/16-4), the National Institute of Environmental Health Sciences (NIEHS R01 ES024332, R01 ES028805, R21 ES028472, P30 ES009089, P30 ES000002), the National Institute on Aging (NIA/NIH R01 AG066793-01, P50 AG025688), and the HERCULES Center (P30ES019776).

Research described what is the generic name of benicar in this article was done under contract to the Health Effects Institute, an organization jointly funded by the U.S. Environmental Protection Agency (assistance award number R-83467701) and some motor vehicle and engine manufacturers.“Long-term effects of PM2.5 what is the generic name of benicar on neurological disorders in the American Medicare population. A longitudinal cohort study,” Liuhua Shi, Xiao Wu, Mahdieh Danesh Yazdi, Danielle Braun, Yara Abu Awad, Yaguang Wei, Pengfei Liu, Qian Di, Yun Wang, Joel Schwartz, Francesca Dominici, Marianthi-Anna Kioumourtzoglou, Antonella Zanobetti, The Lancet Planetary Health, online October 19, 2020, doi. Https://doi.org/10.1016/S2542-5196(20)30227-8Photo.

IStock/hapabapaVisit the Harvard Chan School website for the latest news, press releases, and multimedia offerings.Nicole Rura617.221.4241nrura@hsph.harvard.edu###Harvard T.H. Chan School of Public Health brings together dedicated experts from many disciplines to educate new generations of global health leaders and produce powerful ideas that improve the lives and health of people everywhere. As a community of leading scientists, educators, and students, we work together to take innovative ideas from the laboratory to people’s lives—not only making scientific breakthroughs, but also working to change individual behaviors, public policies, and health care practices. Each year, more than 400 faculty members at Harvard Chan School teach 1,000-plus full-time students from around the world and train thousands more through online and executive education courses.

Founded in 1913 as the Harvard-MIT School of Health Officers, the School is recognized as America’s oldest professional training program in public health.CORVALLIS, Ore. €“ Oregon State University scientists have developed a method that could potentially predict the cancer-causing potential of chemicals released into the air during wildfires and fossil fuel combustion. The research, which was recently published in the journal Toxicology in Vitro, was conducted as a part of the OSU Superfund Research Program. The findings are important for agencies that regulate air pollution caused by these chemicals, known as polycyclic aromatic hydrocarbons (PAHs).

It also could help medical researchers who study patients with conditions such as asthma. PAHs are a class of chemicals that occur naturally in coal, crude oil and gasoline. They also are produced when coal, oil, gas, wood, garbage and tobacco are burned. At high levels, as was the case during recent wildfires in the western United States, when PAHs are inhaled they can be harmful to human health.

Despite PAHs being the first class of chemicals identified as cancer-causing, little is known about the carcinogenic potential of the more than 1,500 PAHs. Part of the challenge is that PAHs usually occur as a mixture of chemicals, making it difficult to tease apart roles of individual chemicals in the mixture. The OSU researchers, led by Susan Tilton, an associate professor in the Department of Environmental and Molecular Toxicology in the College of Agricultural Sciences, have been studying PAHs for over six years. They previously developed a system to predict whether tumors formed in mice exposed to certain PAHs.

The current research translates that approach using human bronchial cells. The researchers treated the cells with individual PAHs and then used computational analysis to look at changes across thousands of genes simultaneously to identify gene signatures. They then looked for gene signatures consistent across the different chemicals with similar carcinogenic potential. €œThose with similar carcinogenic potential are the ones we can focus on,” Tilton said.

€œPotentially, in the future we wouldn’t need to look at thousands and thousands of genes. Once we tested enough chemicals and felt very confident about this we could drill down and look at a select handful of genes in order to make these types of predictions.” In the future, the researchers plan to expand the number of chemicals that they test, particularly chemicals whose carcinogenic potential is not well understood. They also want to study lung cells from people with pre-existing conditions, such as asthma and chronic obstructive pulmonary disease, to see if they are particularly sensitive to certain chemicals. Co-authors of the paper were Yvonne Chang, Celine Thanh Thu Huynh, Kelley M.

Bastin, Brianna N. Rivera, Lisbeth K. Siddens, all of Oregon State..

For immediate benicar online pharmacy release. October 19, benicar online pharmacy 2020Boston, MA – Air pollution was significantly associated with an increased risk of hospital admissions for several neurological disorders, including Parkinson’s disease, Alzheimer’s disease, and other dementias, in a long-term study of more than 63 million older U.S. Adults, led by researchers at Harvard T.H. Chan School benicar online pharmacy of Public Health.The study, conducted with colleagues at Emory University’s Rollins School of Public Health and Columbia University’s Mailman School of Public Health, is the first nationwide analysis of the link between fine particulate (PM2.5) pollution and neurodegenerative diseases in the U.S. The researchers leveraged an unparalleled amount of data compared to any previous study of air pollution and neurological disorders.The study was published online October 19, 2020 in The Lancet Planetary Health.“The 2020 report of the Lancet Commission on dementia prevention, intervention, and care has added air pollution as one of the modifiable risk factors for these outcomes,” said Xiao Wu, doctoral student in biostatistics at Harvard Chan School and co-lead author of the study.

€œOur study builds on the small but emerging evidence base indicating that long-term PM2.5 exposures are linked to an increased risk of neurological health deterioration, even at PM2.5 concentrations well benicar online pharmacy below the current national standards.”Researchers looked at 17 years’ worth (2000–2016) of hospital admissions data from 63,038,019 Medicare recipients in the U.S. And linked benicar online pharmacy these with estimated PM2.5 concentrations by zip code. Taking into account potential confounding factors like socioeconomic status, they found that, for each 5 microgram per cubic meter of air (μg/m3) increase in annual PM2.5 concentrations, there was a 13% increased risk for first-time hospital admissions both for Parkinson’s disease and for Alzheimer’s disease and related dementias. This risk remained elevated even below supposedly safe levels of PM2.5 exposure, which, according to current U.S benicar online pharmacy. Environmental Protection Agency standards, is an annual average of 12 μg/m3 or less.Women, white people, and urban populations were particularly susceptible, the study found.

The highest risk for first-time Parkinson’s disease hospital admissions was among older adults in the benicar online pharmacy northeastern U.S. For first-time Alzheimer’s disease and related dementias hospital admissions, older adults in the Midwest faced the highest risk.“Our U.S.-wide study shows that the current standards are not protecting the aging American population enough, highlighting the need for stricter standards and policies that help further reduce PM2.5 concentrations and improve air quality overall,” said Antonella Zanobetti, principal research scientist in Harvard Chan School’s Department of Environmental Health and co-senior author of the study.Liuhua Shi, research assistant professor at Emory’s Rollins School of Public Health, was a co-lead author and Marianthi-Anna Kioumourtzoglou, assistant professor in environmental health sciences at Columbia’s Mailman School of Public Health, was a co-senior author.Other Harvard Chan School authors included Mahdieh Danesh Yazdi, Danielle Braun, Yaguang Wei, Yun Wang, Joel Schwartz, and Francesca Dominici.This study was supported by the Health Effects Institute (4953-RFA14-3/16-4), the National Institute of Environmental Health Sciences (NIEHS R01 ES024332, R01 ES028805, R21 ES028472, P30 ES009089, P30 ES000002), the National Institute on Aging (NIA/NIH R01 AG066793-01, P50 AG025688), and the HERCULES Center (P30ES019776). Research described in this article was done under contract to the Health Effects Institute, an benicar online pharmacy organization jointly funded by the U.S. Environmental Protection Agency (assistance award number R-83467701) and some motor vehicle and engine manufacturers.“Long-term benicar online pharmacy effects of PM2.5 on neurological disorders in the American Medicare population. A longitudinal cohort study,” Liuhua Shi, Xiao Wu, Mahdieh Danesh Yazdi, Danielle Braun, Yara Abu Awad, Yaguang Wei, Pengfei Liu, Qian Di, Yun Wang, Joel Schwartz, Francesca Dominici, Marianthi-Anna Kioumourtzoglou, Antonella Zanobetti, The Lancet Planetary Health, online October 19, 2020, doi.

Https://doi.org/10.1016/S2542-5196(20)30227-8Photo. IStock/hapabapaVisit the Harvard Chan School website for the latest news, press releases, and multimedia offerings.Nicole Rura617.221.4241nrura@hsph.harvard.edu###Harvard T.H. Chan School of Public Health brings together dedicated experts from many disciplines to educate new generations of global health leaders and produce powerful ideas that improve the lives and health of people everywhere. As a community of leading scientists, educators, and students, we work together to take innovative ideas from the laboratory to people’s lives—not only making scientific breakthroughs, but also working to change individual behaviors, public policies, and health care practices. Each year, more than 400 faculty members at Harvard Chan School teach 1,000-plus full-time students from around the world and train thousands more through online and executive education courses.

Founded in 1913 as the Harvard-MIT School of Health Officers, the School is recognized as America’s oldest professional training program in public health.CORVALLIS, Ore. €“ Oregon State University scientists have developed a method that could potentially predict the cancer-causing potential of chemicals released into the air during wildfires and fossil fuel combustion. The research, which was recently published in the journal Toxicology in Vitro, was conducted as a part of the OSU Superfund Research Program. The findings are important for agencies that regulate air pollution caused by these chemicals, known as polycyclic aromatic hydrocarbons (PAHs). It also could help medical researchers who study patients with conditions such as asthma.

PAHs are a class of chemicals that occur naturally in coal, crude oil and gasoline. They also are produced when coal, oil, gas, wood, garbage and tobacco are burned. At high levels, as was the case during recent wildfires in the western United States, when PAHs are inhaled they can be harmful to human health. Despite PAHs being the first class of chemicals identified as cancer-causing, little is known about the carcinogenic potential of the more than 1,500 PAHs. Part of the challenge is that PAHs usually occur as a mixture of chemicals, making it difficult to tease apart roles of individual chemicals in the mixture.

The OSU researchers, led by Susan Tilton, an associate professor in the Department of Environmental and Molecular Toxicology in the College of Agricultural Sciences, have been studying PAHs for over six years. They previously developed a system to predict whether tumors formed in mice exposed to certain PAHs. The current research translates that approach using human bronchial cells. The researchers treated the cells with individual PAHs and then used computational analysis to look at changes across thousands of genes simultaneously to identify gene signatures. They then looked for gene signatures consistent across the different chemicals with similar carcinogenic potential.

€œThose with similar carcinogenic potential are the ones we can focus on,” Tilton said. €œPotentially, in the future we wouldn’t need to look at thousands and thousands of genes. Once we tested enough chemicals and felt very confident about this we could drill down and look at a select handful of genes in order to make these types of predictions.” In the future, the researchers plan to expand the number of chemicals that they test, particularly chemicals whose carcinogenic potential is not well understood. They also want to study lung cells from people with pre-existing conditions, such as asthma and chronic obstructive pulmonary disease, to see if they are particularly sensitive to certain chemicals. Co-authors of the paper were Yvonne Chang, Celine Thanh Thu Huynh, Kelley M.

Bastin, Brianna N. Rivera, Lisbeth K. Siddens, all of Oregon State..

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