1. Effect of Finerenone on Chronic Kidney Disease Outcomes in Type 2 Diabetes
- Author
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Miguel Urina, Jonathan Barratt, Ru San Tan, Carlos Eduardo Poli de Figueiredo, Bertrand Cariou, Walter Abhayaratna, Sofia Malyutina, Andreas Kistler, Liffert Vogt, Ciprian Constantin, Michal Nowicki, Jingmei Li, Gunnar Gislason, Jonas Spaak, Idalina Beirão, Markus Van der Giet, Ilona Kurnatowska, Peter Rossing, Mario Cozzolino, Maria Isabel Troya, Pathology/molecular and cellular medicine, Diabetes Pathology & Therapy, and Diabetes Clinic
- Subjects
Male ,amyotrophic lateral sclerosis ,Endocrinology, Diabetes and Metabolism ,Terapéutica ,Enfermedad cardiovascular ,Type 2 diabetes ,030204 cardiovascular system & hematology ,urologic and male genital diseases ,Tratamiento médico ,0302 clinical medicine ,Mineralocorticoid receptor ,Malalties cròniques ,Diabetic Nephropathies ,030212 general & internal medicine ,Metabolismo ,Diabetis ,Fallo renal crónico ,Diabetes ,General Medicine ,Phenylbutyrates ,female genital diseases and pregnancy complications ,Treatment Outcome ,Diabetes mellitus tipo 2 ,Creatinine ,Female ,Glomerular filtration rate ,medicine.symptom ,medicine.medical_specialty ,Finerenone ,Urology ,Renal function ,Phenylbutyrate ,Assaigs clínics de medicaments ,03 medical and health sciences ,Double-Blind Method ,Diabetes mellitus ,Chronic renal failure ,medicine ,Albuminuria ,Humans ,Naphthyridines ,Renal Insufficiency, Chronic ,Aged ,urogenital system ,business.industry ,Drug testing ,medicine.disease ,Diabetes Mellitus, Type 2 ,Chronic diseases ,Insuficiència renal crònica ,Hyperkalemia ,business ,Kidney disease - Abstract
Background: Finerenone, a nonsteroidal, selective mineralocorticoid receptor antagonist, reduced albuminuria in short-term trials involving patients with chronic kidney disease (CKD) and type 2 diabetes. However, its long-term effects on kidney and cardiovascular outcomes are unknown. Methods: In this double-blind trial, we randomly assigned 5734 patients with CKD and type 2 diabetes in a 1:1 ratio to receive finerenone or placebo. Eligible patients had a urinary albumin-to-creatinine ratio (with albumin measured in milligrams and creatinine measured in grams) of 30 to less than 300, an estimated glomerular filtration rate (eGFR) of 25 to less than 60 ml per minute per 1.73 m2 of body-surface area, and diabetic retinopathy, or they had a urinary albumin-to-creatinine ratio of 300 to 5000 and an eGFR of 25 to less than 75 ml per minute per 1.73 m2. All the patients were treated with renin-angiotensin system blockade that had been adjusted before randomization to the maximum dose on the manufacturer's label that did not cause unacceptable side effects. The primary composite outcome, assessed in a time-to-event analysis, was kidney failure, a sustained decrease of at least 40% in the eGFR from baseline, or death from renal causes. The key secondary composite outcome, also assessed in a time-to-event analysis, was death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure. Results: During a median follow-up of 2.6 years, a primary outcome event occurred in 504 of 2833 patients (17.8%) in the finerenone group and 600 of 2841 patients (21.1%) in the placebo group (hazard ratio, 0.82; 95% confidence interval [CI], 0.73 to 0.93; P = 0.001). A key secondary outcome event occurred in 367 patients (13.0%) and 420 patients (14.8%) in the respective groups (hazard ratio, 0.86; 95% CI, 0.75 to 0.99; P = 0.03). Overall, the frequency of adverse events was similar in the two groups. The incidence of hyperkalemia-related discontinuation of the trial regimen was higher with finerenone than with placebo (2.3% and 0.9%, respectively). Conclusions: In patients with CKD and type 2 diabetes, treatment with finerenone resulted in lower risks of CKD progression and cardiovascular events than placebo. Bayer; FIDELIO-DKD ClinicalTrials.gov number, NCT02540993. 91.253 JCR (2020) Q1, 1/167 Medicine, General & Internal 19.889 SJR (2020) Q1, 3/2447 Medicine (miscellaneous) No data IDR 2020 UEM
- Published
- 2020