Novartis announced data from a new analysis demonstrating that treatment with Entresto (sacubitril/valsartan) in heart failure patients with reduced ejection fraction (HFrEF) is associated with fewer hospital readmissions for heart failure or for any cause within 30 days of discharge from a heart failure hospitalization compared to patients treated with enalapril. This post-hoc analysis of PARADIGM-HF data was presented at the American Heart Association Scientific Sessions 2015.
The analysis compared numbers and rates of 30-day readmissions after discharge from heart failure hospitalizations in patients treated with Entresto compared to enalapril. The primary outcome analyzed was investigator-reported readmissions for any cause within 30 days of discharge.
Results showed that patients treated with Entresto had 44% fewer hospital readmissions for heart failure and 36% fewer hospital readmissions for any cause within 30 days of discharge from a heart failure hospitalization compared to enalapril. Odds of readmission was 38% and 26% lower with Entresto, respectively, after discharge compared to enalapril.
PARADIGM-HF study, which included 8,442-patients, is the largest clinical trial ever conducted in heart failure. In the study, Entresto met the primary endpoint and demonstrated clinically relevant and statistically significant superiority to enalapril by reducing the risk of cardiovascular death or heart failure hospitalization by 20% at a median follow-up of 27 months. Entresto also had lower incidence of cardiovascular death, showing improved overall survival by 16% vs. enalapril. The study was halted earlier than anticipated due to significantly favorable outcomes.
Entresto, a combination of the neprilysin inhibitor sacubitril and the angiotensin receptor blocker (ARB) valsartan, is indicated to reduce the risk of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure (NYHA Class II-IV) and reduced ejection fraction.
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