![]() ![]() The PARADIGM-HF trial showed a 13% relative reduction in the primary composite endpoint of cardiovascular death and total (first and recurrent) HF hospitalizations, but narrowly missed statistical significance. The approval is based on its superiority to the angiotensin-converting enzyme inhibitor enalpril in reducing cardiovascular death and HF hospitalizations through the PARADIGM-HF trial. Sacubitiril/valsartan is an approved and essential treatment for patients with HFrEF, which is typically defined as ejection fraction less than or equal to 40%. In addition, in a pooled analysis of the PARAGON-HF and PARADIGM-HF, researchers observed a greater treatment benefit in patients with left ventricular ejection fraction below approximately 60%. The benefit with sacubitril/valsartan (Entresto, Novartis) was seen in women with HFpEF and in patients with HFpEF recently hospitalized for HF. These new analyses were presented at the American Heart Association’s (AHA) Scientific Sessions 2019 with simultaneous publication of the gender analysis in Circulation and hospitalization analysis in the Journal of the American College of Cardiology. ![]() Certain subgroups may see a greater reduction in heart failure (HF) hospitalizations and cardiovascular death with the combination of sacubitril and valsartan compared with valsartan alone, according to a new subgroup analysis of the global phase 3 PARAGON-HR study of patients with HF with preserved ejection fraction (HFpEF) or diastolic HF. ![]()
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January 2023
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