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Journal Articles New England Journal of Medicine Year : 2020

Cardiovascular and Renal Outcomes with Empagliflozin in Heart Failure

1 Baylor University Medical Center
2 Imperial College London
3 Charité - UniversitätsMedizin = Charité - University Hospital [Berlin]
4 UMMC - University of Mississippi Medical Center
5 NKUA - National and Kapodistrian University of Athens
6 LSHTM - London School of Hygiene and Tropical Medicine
7 Cardiovascular Division, Department of Cardiology, Washington Veterans Affairs Medical Center, Washington, DC
8 Massachusetts General Hospital [Boston]
9 St. Michael's Hospital
10 University of Toronto
11 Kyushu University
12 Boehringer Ingelheim Pharma GmbH & Co. KG
13 University Hospital Mannheim | Universitätsmedizin Mannheim
14 Universität Heidelberg [Heidelberg] = Heidelberg University
15 Boehringer Ingelheim (Canada) Ltd./Ltee (Burlington)
16 Boehringer Ingelheim Pharmaceuticals, Inc, Ridgefield
17 Australian Centre for Astrobiology
18 USP - Universidade de São Paulo = University of São Paulo
19 Saarland University [Saarbrücken]
20 SNU - Seoul National University [Seoul]
21 Max Superspeciality Hospital, Saket
22 National Institute of Cardiology, Mexico City
23 MUHC - McGill University Health Center [Montreal]
24 University Hospital Gasthuisberg [Leuven]
25 EPOC - Environnements et Paléoenvironnements OCéaniques
26 CHUS - Complejo Hospitalario Universitario de Santiago de Compostela [Saint-Jacques-de-Compostelle, Espagne]
27 Cedars-Sinai Medical Center
28 MUMC - Maastricht University Medical Centre
29 Semmelweis University of Medicine [Budapest]
30 Monash University [Melbourne]
31 Hospital de Alta Complejidad El Cruce "Nestor Kirchner", Florencio Varela, Buenos Aires
32 Wayne State University [Detroit]
33 CMU - Central Michigan University
34 Wrocław Medical University
35 BHF GCRC - British Heart Foundation Glasgow Cardiovascular Research Centre
36 Hosp P Giovanni XXIII - Hospital Papa Giovanni XXIII
37 Service de cardiologie [CHRU de Besançon]
38 University Hospital Brno
39 Glenfield Hospital
40 University of Pisa - Università di Pisa
41 University Hospital of Würzburg
42 DCAC - Défaillance Cardiovasculaire Aiguë et Chronique
43 CIC-P - Centre d'investigation clinique plurithématique Pierre Drouin [Nancy]
44 INI-CRCT - Cardiovascular and Renal Clinical Trialists [Vandoeuvre-les-Nancy]
45 Cardiovascular & Renal Clinical Trialists - CRCT - French-Clinical Research Infrastructure Network - F-CRIN [Paris]
Iain Squire
  • Function : Author


Background: Sodium-glucose cotransporter 2 (SGLT2) inhibitors reduce the risk of hospitalization for heart failure in patients regardless of the presence or absence of diabetes. More evidence is needed regarding the effects of these drugs in patients across the broad spectrum of heart failure, including those with a markedly reduced ejection fraction. Methods: In this double-blind trial, we randomly assigned 3730 patients with class II, III, or IV heart failure and an ejection fraction of 40% or less to receive empagliflozin (10 mg once daily) or placebo, in addition to recommended therapy. The primary outcome was a composite of cardiovascular death or hospitalization for worsening heart failure. Results: During a median of 16 months, a primary outcome event occurred in 361 of 1863 patients (19.4%) in the empagliflozin group and in 462 of 1867 patients (24.7%) in the placebo group (hazard ratio for cardiovascular death or hospitalization for heart failure, 0.75; 95% confidence interval [CI], 0.65 to 0.86; P<0.001). The effect of empagliflozin on the primary outcome was consistent in patients regardless of the presence or absence of diabetes. The total number of hospitalizations for heart failure was lower in the empagliflozin group than in the placebo group (hazard ratio, 0.70; 95% CI, 0.58 to 0.85; P<0.001). The annual rate of decline in the estimated glomerular filtration rate was slower in the empagliflozin group than in the placebo group (-0.55 vs. -2.28 ml per minute per 1.73 m2 of body-surface area per year, P<0.001), and empagliflozin-treated patients had a lower risk of serious renal outcomes. Uncomplicated genital tract infection was reported more frequently with empagliflozin. Conclusions: Among patients receiving recommended therapy for heart failure, those in the empagliflozin group had a lower risk of cardiovascular death or hospitalization for heart failure than those in the placebo group, regardless of the presence or absence of diabetes. (Funded by Boehringer Ingelheim and Eli Lilly; EMPEROR-Reduced number, NCT03057977.).
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Dates and versions

hal-03733888 , version 1 (21-07-2022)



Milton Packer, Stefan D Anker, Javed Butler, Gerasimos Filippatos, Stuart J Pocock, et al.. Cardiovascular and Renal Outcomes with Empagliflozin in Heart Failure. New England Journal of Medicine, 2020, 383 (15), pp.1413-1424. ⟨10.1056/NEJMoa2022190⟩. ⟨hal-03733888⟩
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