The Food and Drug Administration (FDA) has approved Jardiance® (empagliflozin) to reduce the risk of cardiovascular death plus hospitalization for heart failure in adults with heart failure with reduced ejection fraction (HFrEF).
The approval was based on data from the phase 3 EMPEROR-Reduced trial (ClinicalTrials.gov Identifier: NCT03057977), which evaluated the efficacy and safety of empagliflozin as adjunct to standard of care therapy in 3730 adults with chronic heart failure New York Heart Association functional class II-IV) with reduced ejection fraction (left ventricular ejection fraction 40% or less). Patients were randomly assigned 1:1 to receive either empagliflozin 10mg once daily or placebo.
The primary endpoint was the time to first event of either cardiovascular (CV) death or hospitalization for heart failure (HHF). A key secondary endpoint was the occurrence of HHF (first and recurrent).
Results showed that empagliflozin significantly reduced the risk for CV death or HHF by 25% compared with placebo (hazard ratio [HR] 0.75; 95% CI, 0.65-0.86; P <.0001); this was mostly driven through a reduction in HHF. Empagliflozin reduced the risk of first and recurrent HHF by 30% compared with placebo (HR 0.70; 95% CI, 0.58 to 0.85; P =.0003).
“In the EMPEROR-Reduced trial, Jardiance protected a broad range of adults with heart failure with reduced ejection fraction by reducing risk of cardiovascular death and hospitalization for heart failure, regardless of their baseline heart failure medications or type 2 diabetes status, when added to standard of care,” said Mohamed Eid, MD, MPH, MHA, vice president, Clinical Development & Medical Affairs, Cardio-Metabolism & Respiratory Medicine, Boehringer Ingelheim Pharmaceuticals, Inc. “We look forward to continuing to investigate the potential benefit of Jardiance across cardio-renal-metabolic conditions.”
- US FDA approves Jardiance® (empagliflozin) to treat adults living with heart failure with reduced ejection fraction. News release. Eli Lilly and Company. Accessed August 18, 2021. https://www.prnewswire.com/news-releases/us-fda-approves-jardiance-empagliflozin-to-treat-adults-living-with-heart-failure-with-reduced-ejection-fraction-301358260.htm.
- Jardiance [package insert]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc. and Indianapolis, IN: Eli Lilly and Company; 2021.