Novartis' Entresto® given strong Class I recommendation in both US and EU heart failure guidelines, less than a year after regulatory approvals

GlobeNewswire

  • US guidelines now recommend Entresto as standard of care for HFrEF as an alternative to ACEs or ARBs; call for doctors to switch patients with mild to moderate symptoms to Entresto[1]

  • Updated guidelines from the European Society of Cardiology recommend Entresto instead of an ACE or ARB in patients fitting the PARADIGM-HF profile[2]

  • Guidance underscores the benefits of Entresto for patients to significantly reduce risk of death due to cardiovascular causes or heart failure hospitalization

Basel, May 21, 2016 - Entresto® (sacubitril/valsartan) has been given a Class I recommendation, the strongest endorsement, in updated clinical practice guidelines simultaneously released by the American College of Cardiology (ACC), the American Heart Association (AHA) and the Heart Failure Society of America (HFSA) in the US, and the European Society of Cardiology in the EU.

In the US Entresto is now a standard therapy for heart failure with reduced ejection fraction (HFrEF) as an alternative to an ACE inhibitor or an angiotensin II receptor blocker, given together with a beta blocker and an aldosterone antagonist. In addition, the guidelines call for doctors to switch HFrEF patients with mild to moderate symptoms from ACEs or ARBs to Entresto.

"These strong, swift and broad recommendations by US cardiology organizations, redefine the standard of care for how reduced ejection fraction heart failure is treated," said Vas Narasimhan, Global Head of Development and Chief Medical Officer for Novartis. "We know patients with heart failure suffer reduced quality of life and remain at high risk of hospitalization or death, and these new guidelines are a strong call to action to ensure patients receive the most effective therapies."

In the EU, the ESC HF guidelines recommend doctors switch HFrEF patients meeting the PARADIGM-HF criteria to Entresto from an ACE or ARB. Both guideline committees considered evidence from PARADIGM-HF, the largest heart failure trial ever, which showed Entresto significantly reduced deaths from cardiovascular causes and heart failure hospitalizations in patients with HFrEF[3].

Heart failure is a debilitating and life-threatening condition, which impacts over 60 million people worldwide[4]. It is the leading cause of hospitalization in people over the age of 65[5],[6]. About half of people with heart failure have HFrEF[7]. Reduced ejection fraction means the heart does not contract with enough force, so less blood is pumped out[8]. Heart failure presents a major and growing health-economic burden that currently costs the world economy $108 billion every year[5],[9].

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