Efficacy and safety of finerenone in patients with an acute change in estimated glomerular filtration rate in the prespecified FIDELITY pool analysis

作者：Sankar D. Navaneethan, Stefan D. Anker, Gerasimos Filippatos, Bertram Pitt, Peter Rossing, Luís M. Ruilope, Phyllis August, Meike Brinker, Andrea Lage, Luke Roberts, Charlie Scott, Pantelis Sarafidis · 发表于：Kidney International · 年份：2025 · DOI：10.1016/j.kint.2025.03.018 · 被引用次数：16 · 研究领域：Hormonal Regulation and Hypertension、Renin-Angiotensin System Studies、Blood Pressure and Hypertension Studies

INTRODUCTION: The efficacy and safety of finerenone (a nonsteroidal mineralocorticoid receptor antagonist) versus placebo were assessed according to different changes in estimated glomerular filtration rate (eGFR) using data from FIDELITY, a pooled individual-level analysis of two clinical trials. METHODS: or greater) and type 2 diabetes with optimized renin-angiotensin system blockade. Risk of composite cardiovascular and composite kidney outcomes was analyzed by baseline eGFR change at month one in the total population and by treatment group. RESULTS: Of 12,798 patients, 25.1% had a >10% eGFR decline, 31.2% had a >0-10% decline, 26.8% had a 0-10% increase, and 16.8% had a >10% increase after one month of treatment. Factors associated with acute eGFR decline included higher baseline urine albumin-to-creatinine ratio, eGFR, systolic blood pressure, diuretic or beta-blocker use, and finerenone use. Finerenone significantly reduced composite cardiovascular and kidney outcomes overall and had similar beneficial effect across eGFR subgroups of >10% decline, >0-10% decline, 0-10% increase, and >10% increase for composite cardiovascular (hazard ratio [95% Confidence Interval] of 0.74 [0.61-0.90], 0.87 [0.73-1.04], 1.06 [0.87-1.28], and 0.78 [0.61-0.99], respectively) and kidney outcomes (0.67 [0.53-0.85], 0.78 [0.61-1.01], 0.56 [0.40-0.77], and 0.75 [0.50-1.14], respectively) (P interaction 0.048 and 0.23, respectively). When modeled as a continuous variable, finerenone reduced the...