The U.S. Food and Drug Administration (FDA) on Feb. 24 expanded its approval of empagliflozin (Jardiance) for use in adults with heart failure (HF), regardless of ejection fraction, to reduce the risk of cardiovascular death and HF hospitalization. The medication was approved in August 2021 to reduce the risk of cardiovascular death and HF hospitalization in adults with HF with reduced ejection fraction (HFrEF).

Empagliflozin was approved by the FDA in 2014 to improve glucose control in adults with type 2 diabetes. In addition, the medication is approved to reduce the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease.

The approval is based on results from EMPEROR-Preserved, a randomized, double-blind, international trial, that looked at the time to cardiovascular death or HF hospitalization in 2,997 patients who received 10 mg of empagliflozin once per day and 2,991 patients who received a placebo. Among the patients who received empagliflozin for an average of two years, 14% experienced cardiovascular death or HF hospitalization, compared with 17% of patients who received the placebo.

Read the full FDA press release.

Clinical Topics: Heart Failure and Cardiomyopathies, Acute Heart Failure

Keywords: ACC Advocacy, Glucosides, Hospitalization, United States Food and Drug Administration, Heart Failure, Cardiovascular Diseases, Diabetes Mellitus, Type 2, Blood Glucose

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