EMPULSE: empagliflozin delivers rapid and clinically meaningful decongestion

The initiation of empagliflozin therapy in patients who were hospitalised for acute heart failure (HF) was associated with early, clinically meaningful, and sustainable decongestion. This was the main outcome of the EMPULSE trial [1].

The EMPULSE trial (NCT04157751) randomised 530 patients with stabilised acute HF to empagliflozin or placebo. Empagliflozin outperformed placebo concerning the primary endpoint of this study, a composite of all-cause death, HF events, and Kansas City Cardiomyopathy Questionnaire - Total Symptom Score (KCCQ-TSS) change from baseline [2]. The current analysis assessed the decongestive effects of empagliflozin compared to placebo. “This analysis is important as congestion presents the main reason for hospitalisation in patients with acute decompensated HF,” added Prof. Piotr Ponikowski (Medical University of Wroclaw, Poland) [3]. Weight loss measured on day 15, day 30, and day 90 was the primary outcome to assess decongestion.

First, Prof. Ponikowski showed that the weight loss measured on day 15 (P<0.0001) and day 30 (P=0.0004) indeed correlated significantly with positive effects in the primary outcome of the EMPULSE trial. Next, it was demonstrated that weight loss was significantly larger on days 15, 30, and 90 in patients treated with empagliflozin than in patients who received placebo, with adjusted mean differences of -1.97 kg (P<0.0001), -1.74 kg (P=0.0007), and -1.53 kg (P=0.0137), respectively. Correspondingly, change in body weight per mean daily dose of loop diuretic favoured the empagliflozin arm over the placebo arm on day 15 (adjusted mean difference 2.31 kg; P=0.002), day 30 (-2.79 kg; P=0.0152), and at day 90 (-3.18 kg; P=0.0319). Furthermore, the NTproBNP levels of patients in the empagliflozin arm were significantly reduced compared with placebo users at all 3 time points.

“In patients who were hospitalised for acute HF, empagliflozin therapy evoked an early and clinically meaningful decongestion that was maintained until day 90,” summarised Prof. Ponikowski the results of the current analysis.

1. Biegus J, et al. The impact of empagliflozin on decongestion in patients hospitalized for acute heart failure: Analysis from the EMPULSE Trial, LBT 2, Heart Failure 2022, 21–24 May, Madrid, Spain.


2. Voors AA, et al. Nat Med 2022;28:568


3. Chioncel O, et al. Eur J Heart Fail 2017;19:1242–1254

 

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Posted on 25 May, 2022