Effect of Empagliflozin on Cardiovascular and Renal Outcomes in Patients With Heart Failure by Baseline Diabetes Status - Results from the EMPEROR-Reduced Trial - Université de Lorraine Access content directly
Journal Articles Circulation Year : 2020

Effect of Empagliflozin on Cardiovascular and Renal Outcomes in Patients With Heart Failure by Baseline Diabetes Status - Results from the EMPEROR-Reduced Trial

1 BCRT - Berlin Institute of Health Center for Regenerative Therapies
2 German Centre for Cardiovascular Research (DZHK) partner site Berlin
3 Charité - UniversitätsMedizin = Charité - University Hospital [Berlin]
4 UMMC - University of Mississippi Medical Center
5 NKUA - National and Kapodistrian University of Athens
6 UKA - Universitätsklinikum RWTH Aachen - University Hospital Aachen [Aachen, Germany]
7 NHCS - National Heart Centre Singapore
8 Duke-National University of Singapore Graduate Medical School
9 Boehringer Ingelheim Pharma GmbH & Co. KG
10 Medical Department, Boehringer Ingelheim Norway KS, Asker
11 University Hospital Mannheim | Universitätsmedizin Mannheim
12 Universität Heidelberg [Heidelberg] = Heidelberg University
13 SAO PAULO - Heart Institute - Heart Institute
14 Wrocław Medical University
15 Hospital de Alta Complejidad El Cruce "Nestor Kirchner", Florencio Varela, Buenos Aires
16 HMS - Harvard Medical School [Boston]
17 Division of Cardiac Surgery, St Michael's Hospital, University of Toronto
18 Klinik III für Innere Medizin
19 Saarland University [Saarbrücken]
20 CIC-P - Centre d'investigation clinique plurithématique Pierre Drouin [Nancy]
21 DCAC - Défaillance Cardiovasculaire Aiguë et Chronique
22 INI-CRCT - Cardiovascular and Renal Clinical Trialists [Vandoeuvre-les-Nancy]
23 Cardiovascular & Renal Clinical Trialists - CRCT - French-Clinical Research Infrastructure Network - F-CRIN [Paris]
24 Department of Medical Statistics, London School of Hygiene & Tropical Medicine
25 Baylor University Medical Center
26 Imperial College London
Javed Butler
Edimar Bocchi
  • Function : Author
Piotr Ponikowski

Abstract

Background: Sodium-glucose cotransporter 2 (SGLT2) inhibitors improve outcomes in patients with heart failure with reduced ejection fraction, but additional information is needed about whether glycemic status influences the magnitude of their benefits on heart failure and renal events. Methods: Patients with class II-IV heart failure and a left ventricular ejection fraction ≤40% were randomized to receive empagliflozin (10 mg daily) or placebo in addition to recommended therapy. We prespecified a comparison of the effect of empagliflozin in patients with and without diabetes. Results: Of the 3730 patients enrolled, 1856 (50%) had diabetes, 1268 (34%) had prediabetes (HbA1c 5.7-6.4%), and 606 (16%) had normoglycemia (HbA1c <5.7%). The risks of the primary outcome (cardiovascular death or hospitalization for heart failure), total hospitalizations for heart failure, and adverse renal outcomes were higher in patients with diabetes, but were similar between patients with prediabetes and normoglycemia. Empagliflozin reduced the risk of the primary outcome in patients with and without diabetes (hazard ratio 0.72 [95% CI 0.60-0.87] and 0.78 [95% CI 0.64-0.97], respectively, interaction P =0.57). Patients with and without diabetes also did not differ with respect to the effect of empagliflozin on total hospitalizations for heart failure, on the decline in estimated glomerular filtration rate over time, and on the risk of serious adverse renal outcomes. Among these endpoints, the effects of the drug did not differ in patients with prediabetes or normoglycemia. When analyzed as a continuous variable, baseline HbA1c did not significantly modify the benefits of empagliflozin on the primary outcome (P-interaction=0.40). Empagliflozin did not lower HbA1c in patients with prediabetes or normoglycemia and was not associated with increased risk of hypoglycemia. Conclusions: In the EMPEROR-Reduced trial, empagliflozin significantly improved cardiovascular and renal outcomes in patients with heart failure and a reduced ejection fraction, independent of baseline diabetes status and across the continuum of HbA1c.
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hal-03014260 , version 1 (19-11-2020)

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Stefan D Anker, Javed Butler, Gerasimos Filippatos, Muhammad Shahzeb Khan, Nikolaus Marx, et al.. Effect of Empagliflozin on Cardiovascular and Renal Outcomes in Patients With Heart Failure by Baseline Diabetes Status - Results from the EMPEROR-Reduced Trial. Circulation, 2020, 143 (4), pp.337-349. ⟨10.1161/CIRCULATIONAHA.120.051824⟩. ⟨hal-03014260⟩
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