Finerenone cardiovascular and kidney outcomes by age and sex: FIDELITY post hoc analysis of two phase 3, multicentre, double-blind trials

作者：Shweta Bansal, Maria Eugênia Fernandes Canziani, Rita Birne, Stefan D. Anker, George L. Bakris, Gerasimos Filippatos, Peter Rossing, Luís M. Ruilope, Alfredo E. Farjat, Peter Kolkhof, Andrea Lage, Meike Brinker, Bertram Pitt · 发表于：BMJ Open · 年份：2024 · DOI：10.1136/bmjopen-2023-076444 · 被引用次数：33 · 研究领域：Hormonal Regulation and Hypertension、Blood Pressure and Hypertension Studies、Renin-Angiotensin System Studies

Objectives This study aimed to evaluate the efficacy and safety of finerenone, a selective, non-steroidal mineralocorticoid receptor antagonist, on cardiovascular and kidney outcomes by age and/or sex. Design FIDELITY post hoc analysis; median follow-up of 3 years. Setting FIDELITY: a prespecified analysis of the FIDELIO-DKD and FIGARO-DKD trials. Participants Adults with type 2 diabetes and chronic kidney disease receiving optimised renin–angiotensin system inhibitors (N=13 026). Interventions Randomised 1:1; finerenone or placebo. Primary and secondary outcome measures Cardiovascular (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke or hospitalisation for heart failure (HHF)) and kidney (kidney failure, sustained ≥57% estimated glomerular filtration rate (eGFR) decline or renal death) composite outcomes. Results Mean age was 64.8 years; 45.2%, 40.1% and 14.7% were aged <65, 65–74 and ≥75 years, respectively; 69.8% were male. Cardiovascular benefits of finerenone versus placebo were consistent across age (HR 0.94 (95% CI 0.81 to 1.10) (<65 years), HR 0.84 (95% CI 0.73 to 0.98) (65–74 years), HR 0.80 (95% CI 0.65 to 0.99) (≥75 years); P interaction =0.42) and sex categories (HR 0.86 (95% CI 0.77 to 0.96) (male), HR 0.89 (95% CI 0.35 to 2.27) (premenopausal female), HR 0.87 (95% CI 0.73 to 1.05) (postmenopausal female); P interaction =0.99). Effects on HHF reduction were not modified by age (P interaction =0.70) but appeared more pronounced in male...