Novartis announced results of a new analysis demonstrating that Entresto® (sacubitril/valsartan) tablets reduced the risk of all events – first and repeat heart failure (HF) hospitalizations as well as cardiovascular (CV) deaths that followed HF hospitalization – compared to enalapril among heart failure patients with reduced ejection fraction (HFrEF). The findings are from a post-hoc analysis of PARADIGM-HF, the largest clinical trial ever conducted in HF, and are being presented at the American Heart Association (AHA) Scientific Sessions 2016 in New Orleans.
“In PARADIGM-HF, about one-third of heart failure patients with a first event experienced subsequent events – underscoring the substantial risks faced by patients with this life-threatening condition,” said Professor John McMurray of the University of Glasgow, and co-principal investigator for PARADIGM-HF. “The fact that sacubitril/valsartan not only reduced the risk of a first event, but also of repeat events – which are at least as serious and costly, and all too common – is highly significant and reinforces why this medicine is now guideline-directed therapy.”
Investigators conducted a comprehensive analysis of all heart failure hospitalizations and all CV deaths that took place in the PARADIGM-HF trial. A total of 3,181 primary endpoint events (including 1,251 CV deaths) were observed during the median 27-month double-blinded follow-up period of PARADIGM-HF, and about one-third of patients with a primary event also experienced a repeat event (defined as repeat HF hospitalizations or a CV death that followed HF hospitalization). Using multiple statistical analysis models, investigators found that Entresto demonstrated a risk reduction of between 20%-24% for all events (first-time and repeat events) compared to enalapril. These findings are consistent with the proven benefit of Entresto for reducing the risk of a first event in PARADIGM-HF (a 20% risk reduction compared to enalapril on the primary endpoint, a composite measure of time to CV death or first HF hospitalization).
“These analyses further support our knowledge that Entresto can keep many heart failure patients with reduced ejection fraction alive and out of the hospital for longer,” said Vas Narasimhan, Global Head of Development and Chief Medical Officer for Novartis. “As we continue to analyze the results of the PARADIGM-HF study, we become more and more confident in the benefit that Entresto can bring to patients and to potentially reducing costs of care to healthcare systems.”
Additional post-hoc analyses from PARADIGM-HF also presented at AHA Scientific Sessions further support the efficacy and safety benefits of Entresto among a range of HFrEF patients compared to enalapril. These analyses found: