Finerenone in Patients With Chronic Kidney Disease and Type 2 Diabetes by Sodium-Glucose Cotransporter 2 Inhibitor Treatment: The FIDELITY Analysis.

Autor:	Rossing P; Steno Diabetes Center Copenhagen, Herlev, Denmark.; Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark., 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, Berlin, Germany., Filippatos G; School of Medicine, National and Kapodistrian University of Athens, Department of Cardiology, Attikon University Hospital, Athens, Greece., Pitt B; Department of Medicine, University of Michigan School of Medicine, Ann Arbor, MI., Ruilope LM; Cardiorenal Translational Laboratory and Hypertension Unit, Institute of Research Imas12, Madrid, Spain.; CIBER-CV, Hospital Universitario 12 de Octubre, Madrid, Spain.; Faculty of Sport Sciences, European University of Madrid, Madrid, Spain., Birkenfeld AL; German Center for Diabetes Research (DZD), München-Neuherberg, Germany.; Department of Internal Medicine, Division of Diabetology, Endocrinology, and Nephrology, and Institute of Diabetes Research and Metabolic Diseases (IDM), Helmholtz Center Munich and University Hospital Tübingen, Tübingen, Germany., McGill JB; Division of Endocrinology, Metabolism and Lipid Research, Washington University in St. Louis, St. Louis, MO., Rosas SE; Kidney and Hypertension Unit, Joslin Diabetes Center and Harvard Medical School, Boston, MA.; Division of Nephrology, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, MA., Joseph A; Cardiology and Nephrology Clinical Development, Bayer AG, Berlin, Germany., Gebel M; Statistics and Data Insights, Bayer AG, Wuppertal, Germany., Roberts L; Clinical Development, Bayer PLC, Reading, U.K., Scheerer MF; Medical Affairs and Pharmacovigilance, Pharmaceuticals, Bayer AG, Berlin, Germany., Bakris GL; Department of Medicine, University of Chicago Medicine, Chicago, IL., Agarwal R; Richard L. Roudebush VA Medical Center and Indiana University, Indianapolis, IN.
Jazyk:	angličtina
Zdroj:	Diabetes care [Diabetes Care] 2022 Dec 01; Vol. 45 (12), pp. 2991-2998.
DOI:	10.2337/dc22-0294
Abstrakt:	Objective: Finerenone reduced the risk of kidney and cardiovascular events in people with chronic kidney disease (CKD) and type 2 diabetes in the FIDELIO-DKD and FIGARO-DKD phase 3 studies. Effects of finerenone on outcomes in patients taking sodium-glucose cotransporter 2 inhibitors (SGLT2is) were evaluated in a prespecified pooled analysis of these studies. Research Design and Methods: Patients with type 2 diabetes and urine albumin-to-creatinine ratio (UACR) ≥30 to ≤5,000 mg/g and estimated glomerular filtration rate (eGFR) ≥25 mL/min/1.73 m2 were randomly assigned to finerenone or placebo; SGLT2is were permitted at any time. Outcomes included cardiovascular composite (cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure) and kidney composite (kidney failure, sustained ≥57% eGFR decline, or renal death) end points, changes in UACR and eGFR, and safety outcomes. Results: Among 13,026 patients, 877 (6.7%) received an SGLT2i at baseline and 1,113 (8.5%) initiated one during the trial. For the cardiovascular composite, the hazard ratios (HRs) were 0.87 (95% CI 0.79-0.96) without SGLT2i and 0.67 (95% CI 0.42-1.07) with SGLT2i. For the kidney composite, the HRs were 0.80 (95% CI 0.69-0.92) without SGLT2i and 0.42 (95% CI 0.16-1.08) with SGLT2i. Baseline SGLT2i use did not affect risk reduction for the cardiovascular or kidney composites with finerenone (Pinteraction = 0.46 and 0.29, respectively); neither did SGLT2i use concomitant with study treatment. Conclusions: Benefits of finerenone compared with placebo on cardiorenal outcomes in patients with CKD and type 2 diabetes were observed irrespective of SGLT2i use. (© 2022 by the American Diabetes Association.)
Databáze:	MEDLINE
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