Supplementary Material for: Finerenone in Patients with Chronic Kidney Disease and Type 2 Diabetes: FIDELIO-DKD subgroup from China

Background: This prespecified subgroup analysis of the FIDELIO-DKD trial aimed to evaluate the efficacy and safety of finerenone in patients with chronic kidney disease (CKD) and type 2 diabetes mellitus (T2DM) in China. Methods: Three hundred and seventy-two participants were recruited from 67 centers in China and randomized 1:1 to oral finerenone or placebo with standard therapy for T2DM. The primary composite outcome included kidney failure, sustained decrease of estimated glomerular filtration rate (eGFR) ≥ 40% from baseline over at least 4 weeks, or renal death. The key secondary composite outcome included death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure. Results: After a median follow-up of 30 months, the finerenone group showed a relative risk reduction (RRR) of 41% (hazard ratio [HR]=0.59, 95% confidence interval [CI], 0.39 to 0.88; p=0.009) for the primary composite outcome compared with placebo, consistent across its components with treatment benefits with finerenone. Based on an absolute between-group difference of 12.2% after 30 months, the number of patients who needed to be treated (NNT) with finerenone to prevent one primary outcome event was eight (95%CI: 4 to 84). For the key secondary composite outcome, the finerenone group showed a RRR of 25% (HR=0.75, 95% CI, 0.38 to 1.48; p=0.408). Adverse events were similar between the two groups. The effects of finerenone on blood pressure were modest. No gynecomastia events were reported in the study. Hyperkalemia leading to discontinuation occurred in eight (4.3%) and two (1.1%) participants in the finerenone and control groups, respectively. The incidence of acute kidney injury was comparable between the two groups (1.6% vs. 1.6%). Conclusions: Finerenone resulted in lower risks of CKD progression than placebo and a balanced safety profile in Chinese patients with CKD and T2DM.背景：本研究为FIDELIO-DKD试验的预设亚组分析，旨在评估非奈利酮（finerenone）在中国慢性肾脏病（chronic kidney disease, CKD）合并2型糖尿病（type 2 diabetes mellitus, T2DM）患者中的疗效与安全性。方法：本研究从中国67家临床中心招募372名受试者，按1:1比例随机分配至口服非奈利酮组或安慰剂组，两组均接受2型糖尿病标准治疗。主要复合终点包括肾衰竭、估算肾小球滤过率（estimated glomerular filtration rate, eGFR）较基线水平持续下降≥40%且持续至少4周，或肾性死亡。关键次要复合终点包括心血管死亡、非致死性心肌梗死、非致死性卒中，或因心力衰竭住院。结果：中位随访30个月后，与安慰剂组相比，非奈利酮组主要复合终点的相对风险降低（relative risk reduction, RRR）达41%（风险比[hazard ratio, HR]=0.59，95%置信区间[confidence interval, CI]：0.39~0.88；P=0.009），且各终点组分均体现出非奈利酮的治疗获益。基于30个月时两组间12.2%的绝对差值，每需治疗8例患者（95%CI：4~84）即可预防1次主要复合终点事件。针对关键次要复合终点，非奈利酮组相对风险降低25%（HR=0.75，95%CI：0.38~1.48；P=0.408）。两组不良事件发生率相当。非奈利酮对血压的影响较为温和。本研究未报告男性乳房发育（gynecomastia）事件。导致停药的高钾血症（hyperkalemia）分别见于非奈利酮组8例（4.3%）与对照组2例（1.1%）受试者。两组急性肾损伤（acute kidney injury）发生率相当（1.6% vs. 1.6%）。结论：在中国慢性肾脏病合并2型糖尿病患者中，非奈利酮可降低肾脏病进展风险，且安全性良好。