Outcomes with Finerenone in Participants with Stage 4 CKD and Type 2 Diabetes

作者：Pantelis Sarafidis, Rajiv Agarwal, Bertram Pitt, Christoph Wanner, Gerasimos Filippatos, John Boletis, Katherine R. Tuttle, Luís M. Ruilope, Peter Rossing, Robert Toto, Stefan D. Anker, Zhi-Hong Liu, Amer Joseph, Christiane Ahlers, Meike Brinker, Robert Lawatscheck, George L. Bakris, on behalf of the FIDELIO-DKD and FIGARO-DKD Investigators · 发表于：Clinical Journal of the American Society of Nephrology · 年份：2023 · DOI：10.2215/cjn.0000000000000149 · 被引用次数：55 · 研究领域：Heart Failure Treatment and Management、Potassium and Related Disorders、Hormonal Regulation and Hypertension

BACKGROUND: Patients with stage 4 CKD and type 2 diabetes have limited treatment options to reduce their persistent cardiovascular and kidney risk. In Finerenone in Chronic Kidney Disease and Type 2 Diabetes (FIDELITY), a prespecified pooled analysis of Finerenone in Reducing Kidney Failure and Disease Progression in Diabetic Kidney Disease (FIDELIO-DKD) and Finerenone in Reducing Cardiovascular Mortality and Morbidity in Diabetic Kidney Disease (FIGARO-DKD), finerenone improved heart-kidney outcomes in participants with CKD and type 2 diabetes. METHODS: This FIDELITY subgroup analysis investigated the effects of finerenone in participants with stage 4 CKD (eGFR <30 ml/min per 1.73 m 2 ). Efficacy outcomes included a cardiovascular composite (cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure) and a kidney composite (kidney failure, sustained ≥57% decrease in eGFR from baseline, or kidney disease death). RESULTS: Of 13,023 participants, 890 (7%) had stage 4 CKD. The hazard ratio for risk of cardiovascular composite outcome with finerenone versus placebo was 0.78 (95% confidence interval, 0.57 to 1.07). The kidney composite outcome proportional hazards assumption was not met for the overall study period, with a protective effect only shown up to 2 years, after which the direction of association was inconsistent, and an observed loss of precision over time incurred on finerenone versus placebo risk differences. Nonetheles...