The impact of empagliflozin on decongestion in patients hospitalized for acute heart failure

Presented at ESC Heart Failure 2022 by Prof. Piotr Ponikowski, MD (Wroclaw, Poland)

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 investigated the potential decongestive effects of empagliflozin compared with placebo in addition to standard medical treatment.

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 after clinical stabilization in a 1:1 ratio to receive either empagliflozin (10 mg daily) or placebo for 90 days.

The following decongestion markers were investigated in the current analysis: weight loss, weight loss adjusted for mean daily loop diuretic dose, AUC of change from baseline in NT-proBNP levels, hemoconcentration, and change in clinical congestion score.

Main results

• Greater decongestion (as assessed by body weight loss at day 15 and day 30) translated in a higher chance of clinical benefit.
• Patients in the empagliflozin arm had a greater reduction in body weight compared with patients on placebo (adjusted mean difference at day 15: -1.97 kg; 95% CI -2.86 to -1.08 kg; P<0.0001. At day 30: -1.74 kg; 95% CI -2.73 to -0.74; P=0.0007. At day 90: -1.53 kg; 95% CI -2.75 to -0.31; P=0.0137).
• Change in body weight corrected by mean daily dose of loop diuretic was also greater in the empagliflozin arm compared with the placebo arm (adjusted mean difference at day 15: -2.31 kg; 95% CI -3.77 to -0.85 kg; P=0.002. At day 30: -2.79 kg; 95% CI -5.03 to -0.54; P=0.0152. At day 90: -3.18 kg; 95% CI -6.08 to -0.28; P=0.0319).
• AUC of change from baseline in NT-proBNP levels tended to be greater in patients treated with empagliflozin compared with placebo (adjusted geometric mean ratio at day 15: 0.92; 95% CI 0.86-0.98; P=0.010. At day 30: 0.90; 95% CI 0.82-0.98; P=0.018. At day 90: 0.89; 95% CI 0.79-1.00; P=0.056).
• Hemoconcentration was greater in patients on empagliflozin compared with patients on placebo (adjusted mean difference at day 15: 1.71%; 95% CI 1.02-2.4; P<0.0001. At day 30: 1.62%; 95% CI 0.88-2.35; P<0.0001. At day 90: 1.94%; 95% CI 1.11-2.76; P<0.0001).
• The adjusted mean difference in change in clinical congestion score for empagliflozin vs. placebo at was -0.34 points (95% CI -0.60 to -0.09; P<0.01) at day 15 and -0.23 points (95% CI -0.47 to 0.02; P=0.067) at day 90.

Conclusion

Prof. Ponikowski concluded that initiation of empagliflozin in patients hospitalized for acute HF resulted in greater changes of decongestion markers compared with placebo. Decongestion was seen early (at day 15) and was sustainable (until day 90).

– Our coverage of ESC Heart Failure 2022 is based on the information provided during the congress –

Read our summary of the EMPULSE trial