The Food and Drug Administration (FDA) has approved Jardiance® (empagliflozin) to reduce the risk of cardiovascular (CV) death and hospitalization for heart failure (HF) in adults with HF. Previously, the treatment was only approved to reduce the risk of CV death and hospitalization for HF in patients with HF and reduced ejection fraction.
The approval was based on data from the randomized, double-blind, phase 3 EMPEROR-Preserved trial (ClinicalTrials.gov Identifier: NCT03057951), which compared the efficacy and safety of empagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor, to placebo in 5988 adults with HF with preserved ejection fraction, with and without diabetes. The study population included patients with left ventricular ejection fraction (LVEF) <50% (33.1%), LVEF 50 to <60% (34.4%) and LVEF ≥60% (32.5%).
Patients were randomly assigned 1:1 to receive either empagliflozin 10mg once daily (n=2997) or placebo (n=2991), in addition to standard of care for up to 38 months. The primary endpoint of the study was the time to first event of either CV death or hospitalization for HF.
Results showed that the primary outcome event occurred in 13.8% of empagliflozin-treated patients vs 17.1% of those who received placebo, corresponding to a 21% relative risk reduction (hazard ratio [HR] 0.79; 95% CI, 0.69-0.90; P =.0003). The reduction was mostly attributed to a lower risk of hospitalization for HF (HR 0.71; 95% CI, 0.60-0.83).
Treatment with empagliflozin was also associated with significantly lower risk of first and recurrent hospitalizations for HF compared with placebo (hazard ratio 0.73; 95% CI, 0.61-0.88; P =.0009).
Additionally, a recent prespecified sub-analysis of the EMPEROR-Preserved trial showed that treatment with empagliflozin reduced the risk of CV death or hospitalization for HF and slowed kidney function decline in adults with HF and LVEF over 40% regardless of chronic kidney disease status.
“Today’s approval will provide a treatment option for a wider range of patients with heart failure,” said Norman Stockbridge, MD, PhD, Director of the Division of Cardiology and Nephrology in the FDA’s Center for Drug Evaluation and Research. “While Jardiance may not be effective in all patients with heart failure, this approval is a significant step forward for patients and our understanding of heart failure.”
The safety profile of empagliflozin for HF patients was consistent with that observed for patients with diabetes. Urinary tract infections and female genital mycotic infections are the most commonly reported adverse reactions associated with treatment.
Jardiance is also indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (T2DM) and to reduce the risk of CV death in adults with T2DM and established CV disease.
- FDA approves treatment for wider range of patients with heart failure. News release. US Food and Drug Administration. Accessed February 24, 2022. https://www.fda.gov/news-events/press-announcements/fda-approves-treatment-wider-range-patients-heart-failure
- Jardiance. Package insert. Boehringer Ingelheim Pharmaceuticals, Inc.; 2022. Accessed February 24, 2022. https://docs.boehringer-ingelheim.com/Prescribing%20Information/PIs/Jardiance/jardiance.pdf