Empagliflozin provided a significant clinical benefit in adults stabilized in hospital following acute heart failure in EMPULSE Phase III trial.
Adults hospitalized for acute heart failure were 36 percent more likely to experience a clinical benefit over 90 days if initiated on empagliflozin following stabilization and prior to discharge compared with placebo in the Phase III EMPULSE trial , Boehringer Ingelheim and Eli Lilly and Company announced.
Clinical benefit reflected a composite primary endpoint that included 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). The findings were published in Nature Medicine and were recently presented at the American Heart Association’s Late-Breaking Scientific Sessions 2021.
“The first months following hospitalization for heart failure are a particularly vulnerable time for patients,” said Adriaan Voors, Professor of Cardiology, University Medical Center, Groningen, Netherlands, and EMPULSE Principal Investigator. “Current outcomes are poor, underscoring the urgent need for improved in-patient clinical management to prevent further hospitalizations or death. This significant clinical benefit with empagliflozin compared with placebo will advance our understanding of the treatment of heart failure during the early discharge phase.”
Heart failure is a leading cause of hospitalizations, accounting for more than one million per year in the U.S. and Europe. Outcomes for those who have been admitted to the hospital for heart failure are poor, with over 30 percent of patients readmitted within 90 days between 2010 and 2017, according to the U.S.-based National Readmission Database.
The overall clinical benefit with empagliflozin was consistent for those with either new or pre-existing heart failure, for those with or without diabetes and for those with either preserved or reduced ejection fraction. In an exploratory secondary endpoint, empagliflozin significantly improved KCCQ-TSS from baseline to day 90 by 4.5 points versus placebo. The EMPULSE safety results were consistent with the well-established safety profile of empagliflozin. Investigator-reported acute renal failure rates were 7.7 percent for empagliflozin versus 12.1 percent for placebo, and there was a similar low incidence of hypoglycemia in both groups (1.9 percent for empagliflozin versus 1.5 percent for placebo). Volume depletion rates were 12.7 percent versus 10.2 percent respectively.
See-Voors, A.A., Angermann, C.E., Teerlink, J.R. et al. "The SGLT2 inhibitor empagliflozin in patients hospitalized for acute heart failure: a multinational randomized trial". Nat Med (2022). https://doi.org/10.1038/s41591-021-01659-1.
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