학술논문
Finerenone efficacy in patients with chronic kidney disease, type 2 diabetes and atherosclerotic cardiovascular disease.
Document Type
Academic Journal
Author
Filippatos G; Department of Cardiology, School of Medicine, National and Kapodistrian University of Athens, Attikon University Hospital, Athens, Chaidari 12462, Greece.; Anker SD; Department of Cardiology (CVK), and Berlin Institute of Health Center for Regenerative Therapies, German Centre for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, 10117 Berlin, Germany.; Institute of Heart Diseases, Wrocław Medical University, Borowska 213, 50-556 Wrocław , Poland.; Pitt B; Department of Medicine, University of Michigan School of Medicine, Ann Arbor, MI 48109, USA.; McGuire DK; The Division of Cardiology, University of Texas Southwestern Medical Center, and Parkland Health and Hospital System, Dallas, TX 75390, USA.; Rossing P; Steno Diabetes Center Copenhagen, 2730 Herlev, Denmark.; Department of Clinical Medicine, University of Copenhagen, DK-2200 Copenhagen, Denmark.; Ruilope LM; Cardiorenal Translational Laboratory and Hypertension Unit, Institute of Research imas12, s/n, 28041, Madrid, Spain.; CIBER-CV, Hospital Universitario 12 de Octubre, s/n, 28041, Madrid, Spain.; Faculty of Sport Sciences, European University of Madrid, s/n, 28670, Villaviciosa de Odón, Madrid, Spain.; Butler J; Baylor Scott and White Research Institute, Dallas, TX 75204, USA.; The Department of Medicine, University of Mississippi School of Medicine, Jackson, MS 39216, USA.; Jankowska EA; Institute of Heart Diseases, Wrocław Medical University, Borowska 213, 50-556 Wrocław , Poland.; Michos ED; Division of Cardiology, Johns Hopkins University School of Medicine, Baltimore, MD 21287, USA.; Farmakis D; Statistics and Data Insights, University of Cyprus Medical School, Nicosia 2029, Cyprus.; Farjat AE; Research and Development, Statistics and Data Insights, Bayer PLC, Reading, RG2 6AD, UK.; Kolkhof P; Research and Development, Cardiovascular Precision Medicines, Bayer AG, 42117, Wuppertal, Germany.; Scalise A; Pharmaceutical Development, Bayer Hispania, S.L., 08970 Barcelona, Spain.; Joseph A; Cardiology and Nephrology Clinical Development, Bayer AG, Berlin 13353, Germany.; Bakris GL; Department of Medicine, University of Chicago Medicine, Chicago, IL 60637, USA.; Agarwal R; Richard L. Roudebush VA Medical Center and Indiana University, Indianapolis, IN 46202, USA.
Source
Publisher: Oxford University Press Country of Publication: England NLM ID: 101669491 Publication Model: Print Cited Medium: Internet ISSN: 2055-6845 (Electronic) NLM ISO Abbreviation: Eur Heart J Cardiovasc Pharmacother Subsets: MEDLINE
Subject
Language
English
Abstract
Aims: Finerenone, a selective, non-steroidal mineralocorticoid receptor antagonist, improves cardiovascular (CV) and kidney outcomes in patients with type 2 diabetes (T2D) and chronic kidney disease (CKD). This subgroup analysis of FIDELITY, a pre-specified, pooled, individual patient-data analysis of FIDELIO-DKD (NCT02540993) and FIGARO-DKD (NCT02545049), compared finerenone vs. placebo in patients with and without baseline history of atherosclerotic CV disease (ASCVD).
Methods and Results: Outcomes included a composite CV outcome [CV death, non-fatal myocardial infarction, non-fatal stroke, or hospitalization for heart failure (HHF)]; CV death or HHF; a composite kidney outcome (kidney failure, sustained estimated glomerular filtration rate decrease ≥57%, or kidney-related death); all-cause mortality; and safety by baseline history of ASCVD.Of 13 026 patients, 5935 (45.6%) had a history of ASCVD. The incidence of the composite CV outcome, CV death or HHF, and all-cause mortality was higher in patients with ASCVD vs. those without, with no difference between groups in the composite kidney outcome. Finerenone consistently reduced outcomes vs. placebo in patients with and without ASCVD (P-interaction for the composite CV outcome, CV death or HHF, the composite kidney outcome, and all-cause mortality 0.38, 0.68, 0.33, and 0.38, respectively). Investigator-reported treatment-emergent adverse events were consistent between treatment arms across ASCVD subgroups.
Conclusion: Finerenone reduced the risk of CV and kidney outcomes consistently across the spectrum of CKD in patients with T2D, irrespective of prevalent ASCVD.
(© The Author(s) 2022. Published by Oxford University Press on behalf of the European Society of Cardiology.)
Methods and Results: Outcomes included a composite CV outcome [CV death, non-fatal myocardial infarction, non-fatal stroke, or hospitalization for heart failure (HHF)]; CV death or HHF; a composite kidney outcome (kidney failure, sustained estimated glomerular filtration rate decrease ≥57%, or kidney-related death); all-cause mortality; and safety by baseline history of ASCVD.Of 13 026 patients, 5935 (45.6%) had a history of ASCVD. The incidence of the composite CV outcome, CV death or HHF, and all-cause mortality was higher in patients with ASCVD vs. those without, with no difference between groups in the composite kidney outcome. Finerenone consistently reduced outcomes vs. placebo in patients with and without ASCVD (P-interaction for the composite CV outcome, CV death or HHF, the composite kidney outcome, and all-cause mortality 0.38, 0.68, 0.33, and 0.38, respectively). Investigator-reported treatment-emergent adverse events were consistent between treatment arms across ASCVD subgroups.
Conclusion: Finerenone reduced the risk of CV and kidney outcomes consistently across the spectrum of CKD in patients with T2D, irrespective of prevalent ASCVD.
(© The Author(s) 2022. Published by Oxford University Press on behalf of the European Society of Cardiology.)