Updated guidelines released on May 20 from medical societies in the United States and Europe gave a class I recommendation to sacubitril/valsartan (Entresto), a twice-daily oral heart failure medication that the FDA approved last year.
The American College of Cardiology (ACC), American Heart Association (AHA) and the Heart Failure Society of America released their guidelines on sacubitril/valsartan and ivabradine (Corlanor, Amgen) in conjunction with the European Society of Cardiology’s guideline on the diagnosis and treatment of acute and chronic heart failure.
The ACC, AHA and the Heart Failure Society of America said in a news release that they would provide a full update to their guidelines at a later date. The guidelines on sacubitril/valsartan and ivabradine were simultaneously published online in the Journal of the American College of Cardiology, Circulation and the Journal of Cardiac Failure.
The guidelines recommend that patients with chronic symptomatic heart failure with reduced ejection fraction take an ACE inhibitor, an ARB or sacubitril/valsartan with a beta blocker and an aldosterone antagonist. The strength of recommendation for sacubitril/valsartan was deemed as Class I, while the level of evidence was B-R, which means a moderate quality of evidence from at least one randomized controlled trial or meta-analyses of moderate-quality randomized controlled trials.
Patients should take sacubitril/valsartan instead of an ACE inhibitor or an ARB when patients with mild-to-moderate heart failure have adequate blood pressure and are tolerating standard therapies.
However, the guidelines say that patients with a history of angiodemia should not take sacubitril/valsartan. Patients should also not take sacubitril/valsartan with an ACE inhibitor.
During the first quarter of 2016, Novartis reported it had just $17 million in sacubitril/valsartan sales, which was well below analysts’ expectations. These updated guidelines could help convince doctors and payers of the benefits of the medication and could increase sales. A report earlier this month from research and consulting firm GlobalData projected sales of sacubitril/valsartan would reach $5.1 billion in 2022.
“These strong, swift and broad recommendations by US cardiology organizations, redefine the standard of care for how reduced ejection fraction heart failure is treated,” Novartis chief medical officer Vas Narasimhan, MD, said in a news release. “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.”
The societies also said certain patients may have reductions in heart failure hospitalizations if they take ivabradine, which the FDA approved in April 2015. They gave ivabradine a class IIa recommendation and said the drug could be helpful for patients with symptomatic stable chronic heart failure with reduced ejection fraction who are receiving guideline-directed evaluation and management, including a beta blocker at a maximum tolerated dose, and who are in sinus rhythm with a heart rate of 70 beats per minute or greater at rest.