Treatment with empagliflozin was shown to improve clinical outcomes in adults hospitalized for acute heart failure when initiated after stabilization and prior to discharge, according to findings from a phase 3 study.
The randomized, double-blind EMPULSE trial (ClinicalTrials.gov Identifier: NCT04157751) evaluated whether starting empagliflozin soon after being stabilized in the hospital provides a clinical benefit in patients with acute heart failure. Patients (N=530) were randomly assigned to receive empagliflozin 10mg orally once daily or placebo.
The primary endpoint was clinical benefit, defined as a hierarchical composite of all-cause mortality, frequency of heart failure events, time to first heart failure event, and symptoms as measured by the Kansas City Cardiomyopathy Questionnaire total symptom score (KCCQ-TSS) after 90 days of treatment, assessed by the win ratio (the total number of wins for empagliflozin divided by the total number of losses).
Findings showed that patients treated with empagliflozin were 36% more likely to experience a clinical benefit over 90 days compared with those treated with placebo (stratified win ratio, 1.36; 95% CI, 1.09-1.68; P =.0054). The overall clinical benefit was found to be consistent for patients with acute de novo or decompensated chronic heart failure, for those with preserved or reduced ejection fraction, and for those with or without diabetes. Treatment with empagliflozin was also associated with a significant improvement in KCCQ-TSS score of 4.5 points at day 90 (secondary endpoint).
“We are encouraged by the early and significant clinical benefit seen in EMPULSE with [empagliflozin] when initiated in adults with heart failure with either preserved or reduced ejection fraction prior to hospital discharge, including improvements in an endpoint combining mortality, hospitalizations and quality of life,” said Mohamed Eid, MD, MPH, MHA, vice president, Clinical Development & Medical Affairs, Cardio-Metabolism & Respiratory Medicine, Boehringer Ingelheim Pharmaceuticals, Inc.
Empagliflozin is marketed under the brand name Jardiance, which recently received approval from the Food and Drug Administration (FDA) to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure independent of left ventricular ejection fraction.
- Jardiance® provided a significant clinical benefit in adults stabilized in hospital following acute heart failure in EMPULSE phase III trial. News release. Eli Lilly and Company. Accessed March 1, 2022. https://www.prnewswire.com/news-releases/jardiance-provided-a-significant-clinical-benefit-in-adults-stabilized-in-hospital-following-acute-heart-failure-in-empulse-phase-iii-trial-301492927.html
- Voors AA, Angermann CE, Teerlink JR, et al. The SGLT2 inhibitor empagliflozin in patients hospitalized for acute heart failure: a multinational randomized trial. Nat Med. Published online February 28, 2022. doi:10.1038/s41591-021-01659-1