Empagliflozin, Health Status, and Quality of Life in Patients with Heart Failure and Preserved Ejection Fraction: The EMPEROR-Preserved Trial - Université de Lorraine Access content directly
Journal Articles Circulation Year : 2021

Empagliflozin, Health Status, and Quality of Life in Patients with Heart Failure and Preserved Ejection Fraction: The EMPEROR-Preserved Trial

1 UMMC - University of Mississippi Medical Center
2 NKUA - National and Kapodistrian University of Athens
3 “Attikon” University Hospital
4 Boehringer Ingelheim International GmbH
5 Saarland University [Saarbrücken]
6 Max Superspeciality Hospital, Saket
7 DCAC - Défaillance Cardiovasculaire Aiguë et Chronique
8 CIC-P - Centre d'investigation clinique plurithématique Pierre Drouin [Nancy]
9 INI-CRCT - Cardiovascular and Renal Clinical Trialists [Vandoeuvre-les-Nancy]
10 Cardiovascular & Renal Clinical Trialists - CRCT - French-Clinical Research Infrastructure Network - F-CRIN [Paris]
11 Massachusetts General Hospital [Boston]
12 Baim Institute for Clinical Research Boston MA
13 Cedars-Sinai Medical Center
14 Central Michigan University, Mount Pleasant
15 Wrocław Medical University
16 Northwestern University Feinberg School of Medicine
17 Cardiovascular Department, Cardiology Division, Papa Giovanni XXIII Hospital
18 Boehringer Ingelheim AB, Stockholm
19 Division of Cardiac Surgery, St Michael's Hospital, University of Toronto
20 Boehringer Ingelheim Pharma GmbH & Co
21 Department of Medical Statistics, London School of Hygiene & Tropical Medicine
22 Cardiovascular Science, Baylor Heart and Vascular Institute, Baylor University Medical Center
23 Imperial College London
24 Department of Cardiology (CVK); and Berlin Institute of Health Center for Regenerative Therapies (BCRT); German Centre for Cardiovascular Research (DZHK) partner site Berlin; Charité Universitätsmedizin Berlin
Javed Butler
Michael Böhm
Vijay K Chopra
Sanjay Kaul
Piotr Ponikowski

Abstract

Background: Patients with heart failure and preserved ejection fraction (HFpEF) have significant impairment in health-related quality of life (HRQoL). In EMPEROR-Preserved, we evaluated the efficacy of empagliflozin on HRQoL in patients with HFpEF and whether the clinical benefit observed with empagliflozin varies according to baseline health status. Methods: HRQoL was measured using the Kansas City Cardiomyopathy Questionnaire (KCCQ) at baseline, 12, 32 and 52 weeks. Patients were divided by baseline KCCQ Clinical Summary Score (CSS) tertiles and the effect of empagliflozin on outcomes were examined. The effect of empagliflozin on KCCQ-CSS, Total Symptom Score (TSS) and Overall Summary Score (OSS) were evaluated. Responder analyses were performed to compare the odds of improvement and deterioration in KCCQ related to treatment with empagliflozin. Results: The effect of empagliflozin on reducing the risk of time to cardiovascular death or HF hospitalization was consistent across baseline KCCQ-CSS tertiles (HR 0.83 [0.69-1.00], HR 0.70 [0.55-0.88] and HR 0.82 [0.62-1.08] for scores <62.5, 62.5-83.3 and ≥83.3, respectively; P trend=0.77). Similar results were seen for total HF hospitalizations. Patients treated with empagliflozin had significant improvement in KCCQ-CSS versus placebo (+1.03, +1.24 and +1.50 at 12, 32 and 52 weeks, respectively P<0.01); similar results were seen for TSS and OSS. At 12 weeks, patients on empagliflozin had higher odds of improvement ≥5 points (OR 1.23; 95%CI 1.10, 1.37), ≥10 points (1.15; 95%CI 1.03, 1.27), and ≥15 points (1.13; 95%CI 1.02, 1.26) and lower odds of deterioration ≥5 points in KCCQ-CSS (0.85; 95%CI 0.75, 0.97). A similar pattern was seen at 32 and 52 weeks, and results were consistent for TSS and OSS. Conclusions: In patients with HFpEF, empagliflozin reduced the risk for major HF outcomes across the range of baseline KCCQ scores. Empagliflozin improved HRQoL, an effect that appeared early and was sustained for at least one year.
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hal-03467783 , version 1 (06-12-2021)

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Javed Butler, Gerasimos Filippatos, Tariq Jamal Siddiqi, Martina Brueckmann, Michael Böhm, et al.. Empagliflozin, Health Status, and Quality of Life in Patients with Heart Failure and Preserved Ejection Fraction: The EMPEROR-Preserved Trial. Circulation, 2021, ⟨10.1161/CIRCULATIONAHA.121.057812⟩. ⟨hal-03467783⟩
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