Post-hoc analysis of PARADIGM-HF data with Entresto (sacubitril/valsartan) shows benefits in heart failure- Novartis

Novartis announced new post-hoc analyses that underscore the clinical benefits of Entresto (sacubitril/valsartan) tablets compared to enalapril among heart failure patients with reduced ejection fraction (HFrEF), irrespective of patients' clinical stability or background therapy. The analyses are of data from PARADIGM-HF, the largest clinical trial ever conducted in heart failure which compared Entresto to ACE inhibitor enalapril.

Entresto showed consistent benefits among HFrEF patients, reducing the risk of CV death or heart failure hospitalization by approximately 20% compared to enalapril, regardless of background therapy. These benefits were observed for Entresto among patients taking higher and lower doses of beta blockers and those with or without an implantable cardioverter-defibrillator (ICD) or a cardiac resynchronization therapy defibrillator (CRT-D) – two commonly used treatment approaches for heart failure – as well as mineralocorticoid receptor antagonists (MRAs). The data are being presented at the American College of Cardiology's 65th Annual Scientific Session.

Comment: An analysis of PARADIGM-HF patients found that even patients considered to be clinically stable – defined as patients with no history or only a remote history of prior heart failure hospitalization – were still at risk for a serious clinical event. In the analysis, over one third of patients were identified as clinically stable, and 20% of those experienced a primary endpoint event (CV death or heart failure hospitalization). Among these patients, 51% suffered CV death as their first event. Further, the analysis determined that Entresto benefited patients who were considered clinically stable just as much as it did those who were least-stable (heart failure hospitalization within 3 months of baseline).