EMPULSE study - empagliflozin in acute heart failure

EMPULSE study - empagliflozin in acute heart failure

• double-blind trial (EMPULSE) (1)
  • 530 patients with a primary diagnosis of acute de novo or decompensated chronic heart failure regardless of left ventricular ejection fraction were randomly assigned to receive empagliflozin 10 mg once daily or placebo
  • patients were randomized in-hospital when clinically stable (median time from hospital admission to randomization, 3 days) and were treated for up to 90 days
  • primary outcome of the trial was clinical benefit, defined as a hierarchical composite of death from any cause, number of heart failure events and time to first heart failure event, or a 5 point or greater difference in change from baseline in the Kansas City Cardiomyopathy Questionnaire Total Symptom Score at 90 days, as assessed using a win ratio
• study results:
  • more patients treated with empagliflozin had clinical benefit compared with placebo (stratified win ratio, 1.36; 95% confidence interval, 1.09-1.68; p=0.0054), meeting the primary endpoint
  • clinical benefit was observed for both acute de novo and decompensated chronic heart failure and was observed regardless of ejection fraction or the presence or absence of diabetes
  • empagliflozin was well tolerated; serious adverse events were reported in 32.3% and 43.6% of the empagliflozin- and placebo-treated patients, respectively
• study authors concluded:
  • these findings indicate that initiation of empagliflozin in patients hospitalized for acute heart failure is well tolerated and results in significant clinical benefit in the 90 days after starting treatment

A further analysis showed that (2):

• patients treated with empagliflozin demonstrated significantly greater reductions in all studied markers of decongestion at all time-points & greater weight loss at day 15 vs placebo, linked to significantly higher probability for clinical benefit at day 90

Reference:

• Voors AA, et al. The SGLT2 inhibitor empagliflozin in patients hospitalized for acute heart failure: a multinational randomized trial. Nat Med. 2022 Mar;28(3):568-574.
• Biegus J et al. Impact of empagliflozin on decongestion in acute heart failure: the EMPULSE trial, European Heart Journal, 2022; ehac530, https://doi.org/10.1093/eurheartj/ehac530