The FINANCIAL — Novartis announced on April 2 new analyses of the data from PARADIGM-HF showing that Entresto(TM) (sacubitril/valsartan) consistently demonstrated benefit among heart failure patients with reduced ejection fraction (HFrEF), even when patients are considered clinically stable and regardless of background therapy.
An analysis of PARADIGM-HF patients found the following:
Even patients considered clinically stable – defined as patients with no history or 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 considered clinically stable just as much as it did those who were least-stable (heart failure hospitalization within 3 months of baseline).
Among both groups, patients taking Entresto had a 20% or greater reduction in CV death or heart failure hospitalization compared to those taking enalapril.
“This new analysis shows that heart failure patients are never truly stable since in the majority of patients their first clinical event was death. We cannot afford to wait for patients to worsen to use Entresto and improve their chance at a better length of life,” said Vas Narasimhan, Global Head, Drug Development and Chief Medical Officer. “These data also show treating with Entresto led to a 20% or greater reduction in cardiovascular death or heart failure hospitalization in patients with reduced ejection fracture (HFrEF) including those who are considered clinically stable and regardless of background therapy.”
In another analysis of PARADIGM-HF, 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 analyses are from PARADIGM-HF, the largest clinical trial ever conducted in heart failure comparing Entresto to current standard of care, [3] and are being presented at the American College of Cardiology’s 65th Annual Scientific Session in Chicago.
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