Empagliflozin and health-related quality of life outcomes in patients with heart failure with reduced ejection fraction: the EMPEROR-Reduced trial - Université de Lorraine Access content directly
Journal Articles European Heart Journal Year : 2021

Empagliflozin and health-related quality of life outcomes in patients with heart failure with reduced ejection fraction: the EMPEROR-Reduced trial

1 UMMC - University of Mississippi Medical Center
2 Berlin-Brandenburg Center for Regenerative Therapies [Berlin, Germany]
3 German Centre for Cardiovascular Research (DZHK) partner site Berlin
4 Charité - UniversitätsMedizin = Charité - University Hospital [Berlin]
5 NKUA - National and Kapodistrian University of Athens
6 CIC-P - Centre d'investigation clinique plurithématique Pierre Drouin [Nancy]
7 DCAC - Défaillance Cardiovasculaire Aiguë et Chronique
8 INI-CRCT - Cardiovascular and Renal Clinical Trialists [Vandoeuvre-les-Nancy]
9 Cardiovascular & Renal Clinical Trialists - CRCT - French-Clinical Research Infrastructure Network - F-CRIN [Paris]
10 Department of Medical Statistics, London School of Hygiene & Tropical Medicine
11 MUHC - McGill University Health Center [Montreal]
12 Massachusetts General Hospital [Boston]
13 Department of Medicine, Wayne State and Central Michigan Universities
14 NUS - National University of Singapore
15 Centre for Heart Diseases, Wroclaw Medical University
16 BHF Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow
17 Division of Cardiac Surgery, St Michael's Hospital, University of Toronto
18 Boehringer Ingelheim International GmbH
19 Universität Heidelberg [Heidelberg] = Heidelberg University
20 Boehringer Ingelheim AB
21 Boehringer Ingelheim Pharma GmbH & Co
22 Cardiovascular Science, Baylor Heart and Vascular Institute, Baylor University Medical Center
23 Faculty of Medicine, National Heart and Lung Institute, Imperial College,
Javed Butler
Cordula Zeller

Abstract

Aims: In this secondary analysis of the EMPEROR-Reduced trial, we sought to evaluate whether the benefits of empagliflozin varied by baseline health status and how empagliflozin impacted patient-reported outcomes in patients with heart failure with reduced ejection fraction. Methods and results: Health status was assessed by the Kansas City Cardiomyopathy Questionnaires-clinical summary score (KCCQ-CSS). The influence of baseline KCCQ-CSS (analyzed by tertiles) on the effect of empagliflozin on major outcomes was examined using Cox proportional hazards models. Responder analyses were performed to assess the odds of improvement and deterioration in KCCQ scores related to treatment with empagliflozin. Empagliflozin reduced the primary outcome of cardiovascular death or heart failure hospitalization regardless of baseline KCCQ-CSS tertiles [hazard ratio (HR) 0.83 (0.68-1.02), HR 0.74 (0.58-0.94), and HR 0.61 (0.46-0.82) for <62.5, 62.6-85.4, and ≥85.4 score tertiles, respectively; P-trend = 0.10]. Empagliflozin improved KCCQ-CSS, total symptom score, and overall summary score at 3, 8, and 12 months. More patients on empagliflozin had ≥5-point [odds ratio (OR) 1.20 (1.05-1.37)], 10-point [OR 1.26 (1.10-1.44)], and 15-point [OR 1.29 (1.12-1.48)] improvement and fewer had ≥5-point [OR 0.75 (0.64-0.87)] deterioration in KCCQ-CSS at 3 months. These benefits were sustained at 8 and 12 months and were similar for other KCCQ domains. Conclusion: Empagliflozin improved cardiovascular death or heart failure hospitalization risk across the range of baseline health status. Empagliflozin improved health status across various domains, and this benefit was sustained during long-term follow-up.
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hal-03115141 , version 1 (19-01-2021)

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Attribution - NonCommercial

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Javed Butler, Stefan D Anker, Gerasimos Filippatos, Muhammad Shahzeb Khan, João Pedro Ferreira, et al.. Empagliflozin and health-related quality of life outcomes in patients with heart failure with reduced ejection fraction: the EMPEROR-Reduced trial. European Heart Journal, 2021, ⟨10.1093/eurheartj/ehaa1007⟩. ⟨hal-03115141⟩
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