FDA Approves Heart Failure Treatment

The US Food and Drug Administration (FDA) has approved empagliflozin (Jardiance) for reducing the risk of cardiovascular death and hospitalization in adults with heart failure (HF).

This approval follows the results of a randomized, double-blind trial that compared the effectiveness and safety of a daily, 10 mg dose of empagliflozin (n = 2997) with placebo (n = 2991). The results of this study indicate that 14% of individuals who received empagliflozin for 2 years died from cardiovascular causes vs 17% of participants who received the placebo.

This treatment was previously approved in 2014 as a supplemental therapy for improving glycemic control in adults with type 2 diabetes. Empagliflozin is also approved to reduce the risk of cardiovascular death in adults with type 2 diabetes, and to reduce the risk of death and hospitalization in adults with HF and low ejection fraction.

Side effects for each indication of empagliflozin are similar, which includes urinary tract infections and female fungal infections. Empagliflozin should not be used in patients who have had a serious allergic reaction to it or in patients on dialysis.

—Leigh Precopio

Reference:

FDA approves treatment for wider range of patients with heart failure. News release. US Food and Drug Administration; February 24, 2022. Accessed February 25, 2022. https://www.fda.gov/news-events/press-announcements/fda-approves-treatment-wider-range-patients-heart-failure