Τίτλος:
Empagliflozin and health-related quality of life outcomes in patients with heart failure with reduced ejection fraction: the EMPEROR-Reduced trial
Γλώσσες Τεκμηρίου:
Αγγλικά
Περίληψη:
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. Clinical trial registration URL: https://www.clinicaltrials.gov. Unique identifier: NCT03057977. © The Author(s) 2021. Published by Oxford University Press on behalf of the European Society of Cardiology.
Συγγραφείς:
Butler, J.
Anker, S.D.
Filippatos, G.
Khan, M.S.
Ferreira, J.P.
Pocock, S.J.
Giannetti, N.
Januzzi, J.L.
Piña, I.L.
Lam, C.S.P.
Ponikowski, P.
Sattar, N.
Verma, S.
Brueckmann, M.
Jamal, W.
Vedin, O.
Peil, B.
Zeller, C.
Zannad, F.
Packer, M.
the EMPEROR-Reduced Trial Committees
Investigators
Περιοδικό:
EUROPEAN HEART JOURNAL-CARDIOVASCULAR PHARMACOTHERAPY
Εκδότης:
Oxford University Press
Λέξεις-κλειδιά:
empagliflozin; placebo; benzhydryl derivative; empagliflozin; glucoside, aged; Article; controlled study; double blind procedure; drug efficacy; female; heart death; heart failure with reduced ejection fraction; hospitalization; human; Kansas City Cardiomyopathy Questionnaire; major clinical study; male; mortality risk; outcome assessment; quality of life; randomized controlled trial; heart failure; heart stroke volume, Benzhydryl Compounds; Glucosides; Heart Failure; Humans; Quality of Life; Stroke Volume
DOI:
10.1093/eurheartj/ehaa1007
