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The SGLT2 inhibitor empagliflozin in patients hospitalized for acute heart failure: a multinational randomized trial

Adriaan Voors 1, * Christiane Angermann 2 John Teerlink 3 Sean Collins 4 Mikhail Kosiborod 5, 6, 7, 8 Jan Biegus 9 João Pedro Ferreira 10, 11, 12, 13 Michael Nassif 5, 8 Mitchell Psotka 14 Jasper Tromp 15 C. Jan Willem Borleffs 16 Changsheng Ma 17 Joseph Comin-Colet 18 Michael Fu 19 Stefan Janssens 20 Robert Kiss 21 Robert Mentz 22 Yasushi Sakata 23 Henrik Schirmer 24 Morten Schou 25 P. Christian Schulze 26 Lenka Spinarova 27 Maurizio Volterrani 28 Jerzy Wranicz 29 Uwe Zeymer 30 Shelley Zieroth 31 Martina Brueckmann 32, 33 Jonathan Blatchford 34 Afshin Salsali 35, 36 Piotr Ponikowski 9
* Corresponding author
Abstract : The sodium–glucose cotransporter 2 inhibitor empagliflozin reduces the risk of cardiovascular death or heart failure hospitalization in patients with chronic heart failure, but whether empagliflozin also improves clinical outcomes when initiated in patients who are hospitalized for acute heart failure is unknown. In this double-blind trial (EMPULSE; NCT04157751 ), 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. The 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. 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. 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.
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Submitted on : Tuesday, March 1, 2022 - 5:24:23 PM
Last modification on : Friday, April 22, 2022 - 11:42:06 AM

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Adriaan Voors, Christiane Angermann, John Teerlink, Sean Collins, Mikhail Kosiborod, et al.. The SGLT2 inhibitor empagliflozin in patients hospitalized for acute heart failure: a multinational randomized trial. Nature Medicine, Nature Publishing Group, 2022, 28 (3), pp.568-574. ⟨10.1038/s41591-021-01659-1⟩. ⟨hal-03593182⟩

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