Li Ping, Zheng Hongguang, Ma Jianhua, Lu Weiping, Li Ling, Liu Fang, Su Qing, Li Yuxiu, Fang Yi, Mo Zhaohui, Xiong Fei, Yin Aiping, Zhang Ying, Wang Li, Brinker Meike, Roberts Luke, Zhu Dalong
Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School, Nanjing, China.
Nanjing Drum Tower Hospital, Xuzhou Medical University, Xuzhou, China.
Front Endocrinol (Lausanne). 2025 Apr 30;16:1568438. doi: 10.3389/fendo.2025.1568438. eCollection 2025.
Type 2 diabetes (T2D) is a considerable and growing burden in the Chinese population, and affected adults are at high risk of developing chronic kidney disease (CKD). This subgroup analysis of the FIGARO-DKD trial explored the cardiovascular and kidney benefits of finerenone in Chinese patients with CKD and T2D on optimized renin-angiotensin system blockade.
Patients with urine albumin-to-creatinine ratio (UACR) ≥30-<300 mg/g and estimated glomerular filtration rate (eGFR) ≥25-≤90 mL/min/1.73 m, or UACR ≥300-≤5000 mg/g and eGFR ≥60 mL/min/1.73 m, were randomized to finerenone or placebo. The primary cardiovascular composite outcome was time to cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, or hospitalization for heart failure. The secondary kidney composite outcome was time to kidney failure, sustained eGFR decline ≥40% from baseline, or kidney-related death.
A total of 325 Chinese patients were included. Finerenone resulted in a numerical decrease in the risk of the cardiovascular composite outcome (hazard ratio 0.91; 95% confidence interval 0.50-1.67) and a significantly reduced risk of the key secondary kidney outcome (hazard ratio 0.48; 95% confidence interval 0.29-0.79; = 0.0029). The incidence of investigator-reported hyperkalemia was high across both treatment arms. Nevertheless, the incidence of hyperkalemia leading to hospitalization and treatment discontinuation was low across treatment arms.
Finerenone significantly reduced the composite kidney outcome, showed a trend to reduce cardiovascular outcomes, and demonstrated an acceptable safety profile in Chinese patients.
2型糖尿病（T2D）在中国人群中是一个相当大且不断增加的负担，患病成年人患慢性肾脏病（CKD）的风险很高。这项对FIGARO-DKD试验的亚组分析探讨了非奈利酮在中国CKD和T2D患者中，在优化肾素-血管紧张素系统阻断治疗时对心血管和肾脏的益处。
尿白蛋白与肌酐比值（UACR）≥30-<300mg/g且估算肾小球滤过率（eGFR）≥25-≤90mL/min/1.73m²，或UACR≥300-≤5000mg/g且eGFR≥60mL/min/1.73m²的患者被随机分为非奈利酮组或安慰剂组。主要心血管复合结局是心血管死亡、非致死性心肌梗死、非致死性卒中或因心力衰竭住院的时间。次要肾脏复合结局是肾衰竭、eGFR自基线持续下降≥40%或肾脏相关死亡的时间。
共纳入325例中国患者。非奈利酮使心血管复合结局风险有数值上的降低（风险比0.91；95%置信区间0.50-1.67），并显著降低了关键次要肾脏结局的风险（风险比0.48；95%置信区间0.29-0.79；P=0.0029）。两个治疗组中研究者报告的高钾血症发生率都很高。然而，导致住院和治疗中断的高钾血症发生率在各治疗组中都很低。
非奈利酮显著降低了复合肾脏结局，显示出降低心血管结局的趋势，并在中国患者中表现出可接受的安全性。
