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Journal Articles Nature Medicine Year : 2022

The SGLT2 inhibitor empagliflozin in patients hospitalized for acute heart failure

1 UMCG - University Medical Center Groningen [Groningen]
2 University Hospital of Würzburg
3 UC San Francisco - University of California [San Francisco]
4 Vanderbilt University Medical Center [Nashville]
5 Saint Luke's Mid America Heart Institute
6 GIGH - The George Institute for Global Health [Sydney]
7 UNSW - University of New South Wales [Sydney]
8 University of Missouri School of Medicine
9 Wrocław Medical University
10 DCAC - Défaillance Cardiovasculaire Aiguë et Chronique
11 CIC-P - Centre d'investigation clinique plurithématique Pierre Drouin [Nancy]
12 INI-CRCT - Cardiovascular and Renal Clinical Trialists [Vandoeuvre-les-Nancy]
13 FMUP - Faculdade de Medicina da Universidade do Porto
14 Inova Heart and Vascular Institute
15 Saw Swee Hock School of Public Health [Singapore, Singapore]
16 Haga Teaching Hospital [Hague]
17 CUMS - Capital University of Medical Sciences [Beijing]
18 IDIBELL - Institut d'Investigació Biomèdica de Bellvitge = Bellvitge Biomedical Research Institute
19 Sahlgrenska University Hospital [Gothenburg]
20 Department of Cardiovascular Sciences [Leuven]
21 Department of Cardiology, Military Hospital [Budapest]
22 Duke University Medical Center
23 Osaka University [Osaka]
24 Akershus University Hospital [Lørenskog]
25 Gentofte University Hospital
26 Jena University Hospital [Jena]
27 MED / MUNI - Faculty of Medicine [Brno]
28 IRCCS San Raffaele Pisana - Istituto di Ricovero e Cura a Carattere Scientifico
29 MUL - Medical University of Łódź
30 Klinikum Ludwigshafen [Germany]
31 University of Manitoba [Winnipeg]
32 Boehringer Ingelheim International GmbH
33 Medizinische Fakultät Mannheim
34 Boehringer Ingelheim Pharma GmbH & Co. KG
35 RU - Rutgers, The State University of New Jersey [New Brunswick]
Jan Biegus
Uwe Zeymer
Piotr Ponikowski

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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hal-03593182 , version 1 (01-03-2022)

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