Introduction and methods

The EMPULSE trial previously showed that treatment with empagliflozin in patients hospitalized for acute HF resulted in a significant clinical benefit compared with placebo. This analysis of the EMPULSE trial evaluated 1) whether the effects of empagliflozin on total clinical benefit varied according to the symptom burden at baseline, and 2) the effects of empagliflozin on symptoms, functional limitation and quality of life as assessed by KCCQ.

A total of 530 patients with a primary diagnosis of acute HF (de novo or decompensated chronic HF, HFrEF or HFpEF, with or without T2DM) were randomized in a 1:1 ratio to receive either empagliflozin (10 mg daily) or placebo for 90 days. KCCQ was assessed at baseline and at day 15, 30 and 90.

Patients were stratified based on baseline KCCQ-TSS tertiles. Effects of empagliflozin on clinical benefit (a hierarchical composite endpoint of all-cause death, HF events, and ≥5-point change in KCCQ total symptom score [TSS] from baseline to day 90) were studied across the baseline KCCQ-TSS tertiles. In addition, changes from baseline to day 90 in multiple KCCQ domains (TSS, Physical Limitations [PLS], quality of life [QoL], clinical summary [CSS] and overall summary score [OSS]) were examined.

Results

• Patients in the empagliflozin group experienced greater clinical benefit at day 90 than patients in the placebo group across the range of KCCQ-TSS at baseline, with no evidence of treatment effect heterogeneity (P for interaction = 0.94).
• Patients treated with empagliflozin had a greater improvement in KCCQ-TSS, PLS, QoL, CSS and OSS at day 90, compared with patients on placebo (placebo-adjusted mean differences: TSS +4.45 points, 95% CI 0.32-8.59, P=0.03; PLS +4.80 points, 95% CI 0.00-9.61, P=0.05; QoL +4.66 points, 95% CI 0.32-9.01, P=0.04; CSS +4.85 points, 95% CI 0.77-8.92, P=0.02; OSS +4.40 points, 95% CI 0.33-8.48, P=0.03).
• Significant benefits with empagliflozin in all KCCQ domains were seen as early as 15 days.

Conclusion

This analysis of the EMPULSE trial showed that treatment with empagliflozin in patients with acute HF resulted in clinical benefit, regardless of symptomatic impairment at baseline and improved symptoms, physical function and quality of life compared to placebo.

–Our coverage of ACC.22 is based on the information provided during the congress–

The results of this study were simultaneously published in Circulation.