Department of Nephrology, The First Affiliated Hospital of Dalian Medical University, Renal Translational Medicine Center of Liaoning Province, Dalian, China.
Medical College of Dalian University, Dalian, China.
Ren Fail. 2024 Dec;46(2):2400541. doi: 10.1080/0886022X.2024.2400541. Epub 2024 Sep 9.
Finerenone has been approved for treating diabetic kidney disease (DKD) with reducing cardiorenal risk. Real-world data on finerenone treatment for the management of DKD are presently lacking. This study aimed to investigate the effect of finerenone on the renal parameters of the Chinese DKD population in the real-world medical setting for the first time, especially in combination with renin-angiotensin system inhibitors (RASi) and sodium-glucose cotransporter 2 inhibitors (SGLT2i).
Forty-two DKD patients were selected and completed a 6-month finerenone treatment. Renal parameters and adverse effects were collected at every visit.
The median urine albumin-to-creatinine ratio (UACR) was 1426.11 (755.42, 3638.23) mg/g. Among them, the proportion of patients with a UACR of 300-5000 mg/g was 76.2%, and the proportion of patients with a UACR of >5000 mg/g was 14.3%. The median estimated glomerular filtration rate (eGFR) was 54.50 (34.16, 81.73) mL/min/1.73 m. Finerenone decreased the UACR significantly throughout the study period ( < .05). The maximal decline of UACR at month 6 was 73%. Moreover, the proportion of patients with a 30% or greater reduction in UACR was 68.42% in month 6. There was a smaller decline (9-11%) in the eGFR after initiating finerenone ( > .05). One patient each discontinued finerenone due to hyperkalemia (2.4%) and acute kidney injury (2.4%). No patient reported hypotension, breast pain, and gynecomastia.
This study from China first demonstrated finerenone decreased UACR with manageable safety in real-world DKD treatment. A triple regimen of RASi, SGLT2i, and finerenone may be a promising treatment strategy for lowering albuminuria and reducing hyperkalemia risk in advanced DKD patients.
非奈利酮已被批准用于降低心肾风险以治疗糖尿病肾病（DKD）。目前尚无非奈利酮治疗 DKD 的真实世界数据。本研究首次旨在调查非奈利酮在真实世界的医疗环境下对中国 DKD 人群的肾脏参数的影响，尤其是与肾素-血管紧张素系统抑制剂（RASi）和钠-葡萄糖共转运蛋白 2 抑制剂（SGLT2i）联合使用时的效果。
选择了 42 名 DKD 患者，并完成了 6 个月的非奈利酮治疗。每次就诊时均收集肾脏参数和不良反应。
中位尿白蛋白与肌酐比值（UACR）为 1426.11（755.42，3638.23）mg/g。其中，UACR 为 300-5000mg/g 的患者比例为 76.2%，UACR 大于 5000mg/g 的患者比例为 14.3%。中位估算肾小球滤过率（eGFR）为 54.50（34.16，81.73）mL/min/1.73m。非奈利酮在整个研究期间显著降低 UACR（<0.05）。第 6 个月时 UACR 的最大降幅为 73%。此外，第 6 个月时 UACR 降低 30%或更多的患者比例为 68.42%。起始非奈利酮后 eGFR 下降较小（9-11%）（>0.05）。各有 1 例患者因高钾血症（2.4%）和急性肾损伤（2.4%）而停用非奈利酮。无患者报告低血压、乳房疼痛和男性乳房发育。
本研究首次在中国展示了非奈利酮在真实世界 DKD 治疗中降低 UACR 的效果，且安全性可控。RASi、SGLT2i 和非奈利酮三联疗法可能是降低晚期 DKD 患者蛋白尿和降低高钾血症风险的一种有前途的治疗策略。
