Empagliflozin Improves Outcomes in Patients With Heart Failure and Preserved Ejection Fraction Irrespective of Age.

Autor:	Böhm M; Klinik für Innere Medizin III, Universitätsklinikum des Saarlandes, Saarland University, Homburg/Saar, Germany. Electronic address: michael.boehm@uks.eu., Butler J; Department of Medicine, University of Mississippi School of Medicine, Jackson, Mississippi, USA., Filippatos G; National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens, Greece., Ferreira JP; Université de Lorraine, Centre d'Investigation Clinique-Plurithématique Inserm 1433, Centre Hospitalier Regional Universitaire, Nancy Brabois, France; Inserm U1116, CHRU Nancy Brabois, F-CRIN INI-CRCT (Cardiovascular and Renal Clinical Trialists), Nancy, France., Pocock SJ; Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, United Kingdom., Abdin A; Klinik für Innere Medizin III, Universitätsklinikum des Saarlandes, Saarland University, Homburg/Saar, Germany., Mahfoud F; Klinik für Innere Medizin III, Universitätsklinikum des Saarlandes, Saarland University, Homburg/Saar, Germany., Brueckmann M; Boehringer Ingelheim International, Ingelheim, Germany; First Department of Medicine, Faculty of Medicine Mannheim, University of Heidelberg, Mannheim, Germany., Gollop ND; Boehringer Ingelheim International, Ingelheim, Germany., Iwata T; Boehringer Ingelheim Pharma GmbH and Co KG, Biberach/Riss, Germany., Ponikowski P; Wroclaw Medical University, Wrocław, Poland., Wanner C; Medizinische Klinik und Poliklinik 1, Schwerpunkt Nephrologie, Universitätsklinikum Würzburg, Würzburg, Germany., Zannad F; Université de Lorraine, Centre d'Investigation Clinique-Plurithématique Inserm 1433, Centre Hospitalier Regional Universitaire, Nancy Brabois, France; Inserm U1116, CHRU Nancy Brabois, F-CRIN INI-CRCT (Cardiovascular and Renal Clinical Trialists), Nancy, France., Packer M; Baylor University Medical Center, Dallas, Texas, USA; Imperial College, London, United Kingdom., Anker SD; Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Centre for Cardiovascular Research partner site Berlin, Charité Universitätsmedizin Berlin, Berlin, Germany.
Jazyk:	angličtina
Zdroj:	Journal of the American College of Cardiology [J Am Coll Cardiol] 2022 Jul 05; Vol. 80 (1), pp. 1-18.
DOI:	10.1016/j.jacc.2022.04.040
Abstrakt:	Background: Empagliflozin reduces cardiovascular death (CVD) or heart failure (HF) hospitalization (HFH) in patients with HF and preserved ejection fraction. Treatment effects and safety in relation to age have not been studied. Objectives: The purpose of this study was to evaluate the interplay of age and empagliflozin effects in EMPEROR-Preserved (Empagliflozin Outcome Trial in Patients With Chronic Heart Failure With Preserved Ejection Fraction). Methods: We grouped patients (n = 5,988) according to their baseline age (<65 years [n = 1,199], 65-74 years [n = 2,214], 75-79 years [n = 1,276], ≥80 years [n = 1,299]). We explored the influence of age on empagliflozin effects on CVD or HFH (primary outcome), total HFH, rate of decline in estimated glomerular filtration rate, health-related quality of life with the Kansas City Cardiomyopathy Questionnaire-Clinical Summary Score, and frequency of adverse events. Results: Considering only patients on placebo, the incidence of primary outcomes (P trend = 0.02) and CVD (P trend = 0.003) increased with age. Empagliflozin reduced primary outcomes (P trend = 0.33), first HFH (P trend = 0.22), and first and recurrent HFH (P trend = 0.11) across all age groups with an effect being similar at ≥75 years (P interaction = 0.22) or >80 years (P interaction = 0.51). Empagliflozin improved Kansas City Cardiomyopathy Questionnaire-Clinical Summary Score at week 52 and attenuated the decline of estimated glomerular filtration rate without age interaction (P = 0.48 and P = 0.32, respectively). There were no clinically relevant differences in adverse events between empagliflozin and placebo across the age groups. Conclusions: Empagliflozin reduced primary outcomes and first and recurrent HFH and improved symptoms across a broad age spectrum. High age was not associated with reduced efficacy or meaningful intolerability. (Empagliflozin Outcome Trial in Patients With Chronic Heart Failure With Preserved Ejection Fraction [EMPEROR-Preserved]; NCT0305951). Competing Interests: Funding Support and Author Disclosures All authors were involved in the EMPEROR-Preserved trial, which was funded by Boehringer Ingelheim and Eli Lilly. Dr Böhm is supported by the Deutsche Forschungsgemeinschaft (German Research Foundation; TTR 219, project number 322900939); and has received personal fees from Abbott, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Cytokinetics, Medtronic, Novartis, Servier, and Vifor during the conduct of the study. Dr Butler has received consulting fees from Boehringer Ingelheim, Cardior, CVRx, Foundry, G3 Pharma, Imbria, Impulse Dynamics, Innolife, Janssen, LivaNova, Luitpold, Medtronic, Merck, Novartis, Novo Nordisk, Relypsa, Roche, Sanofi, Sequana Medical, V-Wave Ltd, and Vifor; and has received personal fees from Boehringer Ingelheim during the conduct of the study. Dr Filippatos has received Committee Member contributions in trials and personal fees from Boehringer Ingelheim during the conduct of the study. Dr Ferreira has received consulting fees from Boehringer Ingelheim during the conduct of the study. Dr Pocock has received personal fees from Boehringer Ingelheim during the conduct of the study. Dr Mahfoud has received grants and personal fees from Medtronic; and has received personal fees from Recor, Boehringer Ingelheim, and Berlin Chemie. Dr Brueckmann is an employee of Boehringer Ingelheim. Dr Gollop is an employee of Boehringer Ingelheim. Ms Iwata is an employee of Boehringer Ingelheim. Dr Ponikowski has received personal fees from Boehringer Ingelheim, AstraZeneca, Servier, Bristol Myers Squibb, Amgen, Novartis, Merck, Pfizer, and Berlin Chemie; and has received grants and personal fees from Vifor Pharma. Dr Wanner has received personal fees from Boehringer Ingelheim during the conduct of the study; and has received personal fees from Akebia, AstraZeneca, Bayer, Eli Lilly, GlaxoSmithKline, Gilead, Merck Sharp & Dohme, Mundipharma, Sanofi-Genzyme, and Vifor Fresenius outside the submitted work. Dr Zannad has received Steering Committee or Advisory Board fees from Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Boston Scientific, Cardior, CVRx, Janssen, Livanova, Merck, Mundipharma, Novartis, Novo Nordisk, and Vifor Fresenius; and has received personal fees from Boehringer Ingelheim during the conduct of the study. Dr Packer has received consulting fees from Boehringer Ingelheim during the conduct of the study; and has received consulting fees from AbbVie, Akcea, Amarin, AstraZeneca, Amgen, Boehringer Ingelheim, Cardiorentis, Daiichi-Sankyo, Johnson & Johnson, Lilly, Novartis, Pfizer, Relypsa, Sanofi, Synthetic Biologics, Theravance, and Novo Nordisk, outside the submitted work. Dr Anker has received grants and personal fees from Vifor International, and Abbott Vascular; has received personal fees from AstraZeneca, Bayer, Brahms, Boehringer Ingelheim, Cardiac Dimensions, Novartis, Occlutech, Servier, and Vifor International; and has received personal fees from Boehringer Ingelheim during the conduct of the study. Dr Abdin has reported that he has no relationships relevant to the contents of this paper to disclose. (Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.)
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