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Journal Articles New England Journal of Medicine Year : 2021

Empagliflozin in Heart Failure with a Preserved Ejection Fraction

1 BCRT - Berlin-Brandenburg Center for Regenerative Medicine [Berlin, Germany]
2 DZHK - German Center for Cardiovascular Research
3 Charité - UniversitätsMedizin = Charité - University Hospital [Berlin]
4 UMMC - University of Mississippi Medical Center
5 NKUA - National and Kapodistrian University of Athens
6 UOA - Université d'Athènes
7 “Attikon” University Hospital
8 DCAC - Défaillance Cardiovasculaire Aiguë et Chronique
9 CIC-P - Centre d'investigation clinique plurithématique Pierre Drouin [Nancy]
10 INI-CRCT - Cardiovascular and Renal Clinical Trialists [Vandoeuvre-les-Nancy]
11 Cardiovascular & Renal Clinical Trialists - CRCT - French-Clinical Research Infrastructure Network - F-CRIN [Paris]
12 USP - Universidade de São Paulo = University of São Paulo
13 Saarland University [Saarbrücken]
14 SNUBH - Seoul National University Bundang Hospital
15 Max Superspeciality Hospital, Saket
16 National Institute of Cardiology, Mexico City
17 MUHC - McGill University Health Center [Montreal]
18 ICESI - Universidad Icesi
19 University Hospitals Leuven [Leuven]
20 Massachusetts General Hospital [Boston]
21 Baim Institute for Clinical Research Boston MA
22 CHUS - Complejo Hospitalario Universitario de Santiago de Compostela [Saint-Jacques-de-Compostelle, Espagne]
23 Semmelweis University of Medicine [Budapest]
24 Monash University [Melbourne]
25 Argentine Catholic University
26 FLENI - Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia [Buenos Aires]
27 IADT - Instituto Argentino de Diagnóstico y Tratamiento [Buenos Aires]
28 CMU - Central Michigan University
29 Wrocław Medical University
30 Hosp P Giovanni XXIII - Hospital Papa Giovanni XXIII
31 NHCS - National Heart Centre Singapore
32 University Hospital Brno
33 University of Leicester
34 University of Pisa - Università di Pisa
35 Kyushu University
36 St. Michael's Hospital
37 UMPCD - University of Medicine and Pharmacy “Carol Davila” Bucharest
38 WMU - Wenzhou Medical University [Wenzhou, China]
39 Washington Veterans Medical Center
40 Duke-NUS Medical School [Singapore]
41 UMCG - University Medical Center Groningen [Groningen]
42 GIGH - The George Institute for Global Health [Sydney]
43 RWTH - Rheinisch-Westfälische Technische Hochschule Aachen University
44 Boehringer Ingelheim Pharma GmbH & Co. KG
45 Institute of Cardiovascular and Medical Sciences [Glasgow]
46 Boehringer Ingelheim International GmbH
47 Boehringer Ingelheim Pharmaceuticals, Inc, Ridgefield
48 LSHTM - London School of Hygiene and Tropical Medicine
49 Baylor Heart and Vascular Institute
Milton Packer


Background: Sodium-glucose cotransporter 2 inhibitors reduce the risk of hospitalization for heart failure in patients with heart failure and a reduced ejection fraction, but their effects in patients with heart failure and a preserved ejection fraction are uncertain. Methods: In this double-blind trial, we randomly assigned 5988 patients with class II-IV heart failure and an ejection fraction of more than 40% to receive empagliflozin (10 mg once daily) or placebo, in addition to usual therapy. The primary outcome was a composite of cardiovascular death or hospitalization for heart failure. Results: Over a median of 26.2 months, a primary outcome event occurred in 415 of 2997 patients (13.8%) in the empagliflozin group and in 511 of 2991 patients (17.1%) in the placebo group (hazard ratio, 0.79; 95% confidence interval [CI], 0.69 to 0.90; P<0.001). This effect was mainly related to a lower risk of hospitalization for heart failure in the empagliflozin group. The effects of empagliflozin appeared consistent in patients with or without diabetes. The total number of hospitalizations for heart failure was lower in the empagliflozin group than in the placebo group (407 with empagliflozin and 541 with placebo; hazard ratio, 0.73; 95% CI, 0.61 to 0.88; P<0.001). Uncomplicated genital and urinary tract infections and hypotension were reported more frequently with empagliflozin. Conclusions: Empagliflozin reduced the combined risk of cardiovascular death or hospitalization for heart failure in patients with heart failure and a preserved ejection fraction, regardless of the presence or absence of diabetes. (Funded by Boehringer Ingelheim and Eli Lilly; EMPEROR-Preserved ClinicalTrials.gov number, NCT03057951).
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Dates and versions

hal-03734440 , version 1 (21-07-2022)



Stefan D Anker, Javed Butler, Gerasimos Filippatos, João P Ferreira, Edimar Bocchi, et al.. Empagliflozin in Heart Failure with a Preserved Ejection Fraction. New England Journal of Medicine, 2021, 385 (16), pp.1451-1461. ⟨10.1056/NEJMoa2107038⟩. ⟨hal-03734440⟩
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