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Efficacy Of Finerenone In Asian Patients With Type 2 Diabetes And Chronic Kidney Disease: A FIDELITY Analysis
Satoshi Yamashita
2024 ; 2024(1):
논문분류 :
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Objectives: Finerenone significantly reduced the risk of cardiovascular (CV) and kidney outcomes versus placebo in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) in FIDELITY, a prespecified pooled analysis of the phase III FIDELIO-DKD and FIGARO-DKD trials. This FIDELITY post-hoc subanalysis assessed the efficacy of finerenone in Asian patients. Methods: Patients with CKD (urine albumin-to-creatinine ratio [UACR] 30–<300 mg/g and estimated glomerular filtration rate [eGFR] 25−≤90 ml/min/1.73 m2, or UACR 300–≤5000 mg/g and eGFR ≥25 ml/min/1.73 m2) and T2D, and on optimised renin–angiotensin system blockade were randomised 1:1 to finerenone or placebo in FIDELIO-DKD and FIGARO-DKD. For this subgroup analysis, composite CV (CV death, non-fatal myocardial infarction, non-fatal stroke or hospitalisation for heart failure) and ≥57% eGFR composite kidney (kidney failure, sustained ≥57% eGFR decrease from baseline over ≥4 weeks or renal death) outcomes were assessed. Additional analyses included ≥40% eGFR kidney composite outcome (kidney failure, sustained ≥40% eGFR decrease from baseline over ≥4 weeks or renal death), all outcomes by baseline eGFR (<60 and ≥60 ml/min/1.73 m2) and UACR (<300 and ≥300 mg/g) subgroups and eGFR slope. Results: Of 13,026 patients randomised, 22.2% self-identified as Asian. Asian patients receiving finerenone had a lower risk of the composite CV outcome (hazard ratio [HR] 0.90; 95% confidence interval [CI] 0.70–1.15), and nominally significant reductions in the risk of ≥57% and ≥40% eGFR composite kidney outcomes (HR=0.66; 95% CI 0.52–0.84 and HR=0.68; 95% CI 0.57–0.81, respectively) versus those receiving placebo. Similar trends were observed for these outcomes irrespective of baseline eGFR and UACR (p-value for interaction not significant) (Figure 1). CKD progression was also slower with finerenone compared with placebo (Figure 2). Conclusions: In FIDELITY, finerenone lowered the risks of CV and kidney outcomes versus placebo in Asian patients irrespective of eGFR and UACR levels at baseline.
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