FDA Approves Empagliflozin For Adults With HFrEF

The U.S. Food and Drug Administration (FDA) on Aug. 18 approved empagliflozin (Jardiance) to reduce the risk of cardiovascular death and hospitalization in adults with heart failure with reduced ejection fraction (HFrEF).

The approval is based on results of the EMPEROR-Reduced Phase III trial, which investigated the effects of adding 10 mg empagliflozin vs. placebo to standard care in 3,730 adults with and without type 2 diabetes with HF and a left ventricular ejection fraction of 40% or less. The trial found that empagliflozin significantly reduced the risk of cardiovascular death or hospitalization for HF by 25% vs. placebo. The trial also found that empagliflozin reduced the relative risk of first hospitalization and readmissions for HF by 30%.

Read the press release from Boehringer Ingelheim.

Clinical Topics: Heart Failure and Cardiomyopathies, Acute Heart Failure

Keywords: Stroke Volume, Heart Failure, Diabetes Mellitus, Type 2, Patient Readmission, United States Food and Drug Administration, Ventricular Function, Left, Glucosides, Benzhydryl Compounds, Hospitalization, ACC Advocacy

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