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EMPULSE: Empagliflozin improves outcomes of acute heart failure

Presented by
Prof. Adriaan Voors, University of Groningen, the Netherlands
AHA 2021
Phase 3, EMPULSE

Patients hospitalised for acute heart failure (HF) who were treated with empagliflozin showed significant clinical benefits over patients who were treated with placebo in the phase 3 EMPULSE trial. Empagliflozin therapy was associated with fewer deaths and HF events. Moreover, the agent showed a favourable safety profile in this vulnerable population [1].

Empagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor that has demonstrated efficacy in the treatment of patients with chronic HF [2,3]. The randomised, double-blind, placebo-controlled, phase 3 EMPULSE trial (NCT04157751) aimed to assess the efficacy and safety of empagliflozin in hospitalised patients with acute HF. De novo or decompensated hospitalised patients with a primary diagnosis of acute HF were eligible for inclusion, regardless of ejection fraction or diabetes status. After stabilisation, patients were randomised to 10 mg empagliflozin once daily (n=265) or placebo (n=265). Kansas City Cardiomyopathy Questionnaire Total Symptom Score (KCCQ-TSS) at baseline was approximately 38, indicating severe disease in the study population. The primary endpoint was a composite of death, number of HF events, time to first HF event, and change from baseline KCCQ-TSS, assessed by stratified win ratio following the aforementioned sequence. The 90-day results were presented by Prof. Adriaan Voors (University of Groningen, the Netherlands).

Participants receiving empagliflozin demonstrated an increased probability of experiencing clinical benefit (53.0%) compared with patients receiving placebo (39.7%; P=0.0054). Death was observed in 4.2% and 8.3% of the patients in the empagliflozin arm and placebo arm, respectively. Moreover, HF events were more common among placebo receivers (14.7%) than in empagliflozin receivers (10.6%). Subgroup analyses displayed consistency over the predefined strata, in particular regarding HF status (de novo or decompensated chronic), diabetes status, and ejection fraction (≤40% and >40%). In addition, the quality of life after 90 days was enhanced in patients receiving empagliflozin, which was reflected by a mean 4.5-point difference in KCCQ-TSS between the empagliflozin arm and the placebo arm (P=0.0347).

The safety profile of empagliflozin was favourable. Any adverse events were reported in 70.0% of the patients in the empagliflozin arm and in 77.3% of the patients in the placebo arm. Serious adverse events were less common among empagliflozin receivers (32.3%) than in placebo receivers (43.6%). Acute renal failure was observed in 7.7% and 12.1% of the patients in the experimental arm and placebo arm, respectively.

Discussant Dr Nancy Sweitzer (University of Arizona, AZ, USA) added that empagliflozin was efficacious in this population, regardless of background therapy. “De novo patients were not treated with guideline-recommended therapies but experienced equal benefits from treatment with empagliflozin. Therefore, I think we should not withhold this agent while other drug classes are being initiated and optimised. However, it is interesting to investigate how empagliflozin interacts with other drug classes, for example with regard to renal function, in future studies.”

    1. Voors AA, et al. Empagliflozin in patients hospitalized for acute heart failure: the EMPULSE trial. LBS05, AHA 2021 Scientific Sessions, 13–15 November. 

    2. Anker SD, et al. N Engl J Med 2021;385:1451–1461.

    3. Packer M, et al. N Engl J Med 2020;383:1413–1424.


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