Efficacy and safety of finerenone in patients with chronic kidney disease: an individual participant data pooled analysis (INFINITY).

Finerenone, a non-steroidal mineralocorticoid receptor antagonist, has shown kidney and cardiovascular benefits in CKD due to type 2 diabetes, but its efficacy and safety across disease aetiologies, and levels of glycaemia, estimated glomerular filtration rate (eGFR), and albuminuria have not been evaluated.

非甾体矿物皮质激素受体拮抗剂Finerenone在2型糖尿病引起的CKD中显示出肾脏和心血管益处，但其在不同病因、血糖水平、估算肾小球滤过率（eGFR）和白蛋白尿水平中的疗效和安全性尚未得到评估。

The aim of this study was to evaluate the efficacy and safety of finerenone across the spectrum of CKD.

本研究旨在评估非奈利酮在慢性肾脏病（CKD）全谱中的疗效和安全性。

Methods

We conducted an individual participant data meta-analysisof three randomised, double-blind, placebo-controlledtrials of finerenone in patients with CKD: FIDELIO-DKD (NCT02540993; Sept 17, 2015, to April 14, 2020), FIGARO-DKD (NCT02545049; Sept 17, 2015, to Feb 2, 2021), and FIND-CKD (NCT05047263; Sept 21, 2021, to Feb 2, 2026).

我们对三项随机、双盲、安慰剂对照试验进行了个体患者数据的荟萃分析，这些试验评估了非奈利酮在慢性肾脏病（CKD）患者中的疗效和安全性：FIDELIO-DKD（NCT02540993；2015年9月17日至2020年4月14日）、FIGARO-DKD（NCT02545049；2015年9月17日至2021年2月2日）和FIND-CKD（NCT05047263；2021年9月21日至2026年2月2日）。

We used Cox regression models to evaluate relative effects on kidney and cardiovascular outcomes.

我们使用Cox回归模型评估对肾脏和心血管结果的相对效应。

The main kidney outcome was kidney failure or sustained 57% or more decline in eGFR; the main cardiovascular outcome was hospitalisation for heart failure or cardiovascular death.

主要的肾脏结果是肾衰竭或eGFR持续下降57%或更多；主要的心血管结果是因心力衰竭住院或心血管死亡。

This study was registered with PROSPERO, CRD420251269149.

这项研究已在PROSPERO注册，注册号为CRD420251269149。

Results

Across the three trials enrolling 14 574 participants, the mean age was 63·7 years (SD 10·6), 4467 (30·7%) were female, 10 107 (69·3%) were male, mean eGFR was 56·4 mL/min per 1·73 m2 (SD 21·4), and median urinary albumin-to-creatinine ratio was 567·4 mg/g (IQR 233·6-1164·7).

在纳入14,574名参与者的三项试验中，平均年龄为63.7岁（标准差10.6），女性4,467人（30.7%），男性10,107人（69.3%），平均eGFR为每1.73平方米56.4毫升/分钟（标准差21.4），中位尿白蛋白肌酐比值为567.4毫克/克（四分位数间距233.6-1164.7）。

Finerenone reduced the risk of the composite kidney outcome by 24% versus placebo (22·3 vs 28·8 events per 1000 patient-years; hazard ratio0·76 [95% CI 0·68-0·86]) and kidney failure alone (0·85 [0·74-0·99]).

Finerenone 将复合肾脏结果的风险降低了 24%，与安慰剂相比（22.3 对比 28.8 事件每千患者年；风险比 0.76 [95% 置信区间 0.68-0.86]），以及单独的肾衰竭（0.85 [0.74-0.99]）。

Finerenone reduced the risk of the composite cardiovascular outcome versus placebo (19·1 vs 23·9 events per 1000 patient-years; 0·80 [0·70-0·91]), including heart failure hospitalisation (0·78 [0·66-0·92]) and cardiovascular death (0·82 [0·67-0·999]).

Finerenone 与安慰剂相比，降低了复合心血管结果的风险（19.1 对比 23.9 事件每千患者年；0.80 [95% 置信区间 0.70-0.91]），包括心力衰竭住院（0.78 [0.66-0.92]）和心血管死亡（0.82 [0.67-0.999]）。

Finerenone also reduced the risk of all-cause death (0·88 [0·79-0·99]).

Finerenone 还降低了全因死亡风险（0·88 [0·79-0·99]）。

Treatment effects on the composite kidney outcome were consistent irrespective of glycaemic status, CKD aetiology, baseline eGFR, albuminuria, and use of sodium-glucose co-transporter-2 inhibitors.

治疗对复合肾脏结果的影响在血糖状态、慢性肾脏病病因、基线估算肾小球滤过率、白蛋白尿和钠-葡萄糖共转运蛋白-2抑制剂的使用方面是一致的。

Hyperkalaemia occurred more frequently with finerenone than with placebo, but the absolute incidenceof hyperkalaemia leading to hospitalisation was low.

与安慰剂相比，使用非奈利酮的患者出现高钾血症的频率更高，但导致住院的高钾血症的绝对发生率较低。

interpretation

In the studied populations with CKD, finerenone reduced the risk of CKD progression, including kidney failure alone, and reduced heart failure hospitalisation, cardiovascular death, and all-cause death.

在研究的慢性肾脏病（CKD）人群中，非奈利酮降低了CKD进展的风险，包括单纯肾衰竭，以及降低了心力衰竭住院、心血管死亡和全因死亡的风险。

These findings support finerenone as a foundational therapy for CKD across a broad range of disease aetiologies and levels of glycaemia, eGFR, and albuminuria.

这些发现支持使用芬瑞酮作为各种病因、血糖水平、估算肾小球滤过率（eGFR）和白蛋白尿水平的慢性肾脏病（CKD）的基础治疗。

funding

Bayer.

拜耳公司。