Novartis announced data from new post-hoc analyses that support Entresto (sacubitril/valsartan) tablets vs. enalapril in heart failure patients with reduced ejection fraction (HFrEF), irrespective of patients’ clinical stability or background therapy. Findings from the study were presented at the American College of Cardiology’s 65th Annual Scientific Session. 

The analyzed data come from PARADIGM-HF, the largest clinical trial conducted in heart failure that compared Entresto to enalapril, an ACE inhibitor. An analysis showed that patients considered clinically stable were still at risk for a serious clinical event. Over 1/3 of patients were identified as clinically stable but 20% of these patients experienced a primary endpoint event (eg, cardiovascular [CV] death or heart failure hospitalization); 51% of which experienced CV death as their first event.

Treatment with Entresto helped patients who were considered clinically stable as much as those who were least-stable, leading to a ≥20% reduction in CV death or heart failure hospitalization vs. treatment with enalapril.

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In another analysis, Entresto reduced the risk of CV death or heart failure hospitalization by ~20% vs. enalapril regardless of background therapy in patients with HFrEF. These benefits were seen for patients taking lower and higher doses of beta-blockers and those with or without an implantable cardioverter-defibrillator (ICD) or a cardiac resynchronization therapy defibrillator (CRT-D) as well as mineralocorticoid receptor antagonists (MRAs). 

Entresto combines sacubitril, a neprilysin inhibitor, and valsartan, an angiotensin receptor blocker (ARB). It is indicated to reduce the risk of CV death and hospitalization for heart failure patients with chronic heart failure (NYHA Class II-IV) and reduced ejection fraction, usually given with other therapies in place of an ACE inhibitor or other ARB. It is available as 24mg/26mg, 49mg/51mg, and 97mg/103mg strength tablets.

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