US and European professional societies coordinated their announcement to reduce confusion for physicians and payers.
A new drug to treat heart failure—the angiotensin receptor-neprilysin inhibitor (ARNI)—should replace current therapies for certain patients with mild to moderate heart failure, according to an updated recommendation from the leading professional medical groups in the United States and Europe.
Late Friday, the American College of Cardiology (ACC), the American Heart Association (AHA), and the Heart Failure Society of America published an update in the Journal of the American College of Cardiology (JACC). The update was timed to coordinate with similar guidance from the European Society of Cardiology; an editorial in JACC said the coordinated effort is designed “to promote optimal care for all patients with all forms of cardiovascular disease, to improve outcomes and enhance quality of life around the world.”1,2
Novartis’ Entresto, a combination of valsartan and sacubitril, is expected to get a sales boost based on the recommendation. The key recommendation called for ARNIs to replace angiotensin-converting enzyme (ACE) inhibitors and angiotensin II receptor blockers (ARBs) to treat patients with stable heart failure, adequate blood pressure, and good drug tolerance. ARNIs should not be given alongside an ACE inhibitor or to patients with a history of angioedema.
In heart failure (HF), the heart muscle weakens, causing inadequate pumping of blood through the body. Patients with this condition experience shortness of breath, chronic coughing, loss of appetite, and they can experience cognitive symptoms.
The societies gave Entresto a “Class I” recommendation, the highest available, based on evidence from the 2014 PARADIGM trial, which found a 20% reduction in the composite endpoint of CV death or HF hospitalization.
In anticipation of Friday’s news, Novartis announced increased investment in a global program of 4 clinical trials over the next 5 years, which will evaluate the long-term safety and efficacy of Entresto.
Friday’s recommendations also said that Amgen’s Corlanor (ivabradine) “may be beneficial in reducing HF hospitalizations in patients with symptomatic stable chronic HF with reduced ejection fraction,” who are being treated according to guidelines and met other clinical benchmarks, according to a statement from ACC. The committee rated the evidence for ivabradine Class IIa.
“Not every patient is a good candidate for every drug; these guidelines can help physicians decide who best fits which treatment,” said Clyde W. Yancy, MD, MSc, MACC, who chairs the guideline writing committee.
“This document details the benefits and risks of these new therapies so that patients at high risk can be directed towards alternative therapies,” he said.
For coverage of the recent 65th Scientific Sessions of the ACC, click here.
1. Yancy CW, Jessup M, Bozkurt B, et al. Report of the American College of Cardiology/American Heart Association task force on clinical practice guidelines and the Heart Failure Society of America [published May 20, 2016]. J Am Coll Cardiol. 2016; doi:10.1016/j.jacc.2016.05.011.
2. Antman EM, Bax J, Chazal RA. Updated clinical practice guidelines on heart failure: an international alignment [published online May 20, 2016]. J Am Coll Cardiol. 2016; doi:10.1016/j.jacc.2016.05.012