Finerenone in Persons with Chronic Kidney Disease without Diabetes.

Whether finerenone has similar effects in patients without diabetes who have CKD is unknown.

finerenone在没有糖尿病但患有CKD的患者中是否有类似效果尚不清楚。

Methods

We randomly assigned adults without diabetes who had CKD (estimated glomerular filtration rate [eGFR], 25 to <90 ml per minute per 1.73 m2 of body-surface area) and albuminuria (urinary albumin-to-creatinine ratio, 200 to ≤3500, with albumin in milligrams and creatinine in grams) and were using a renin-angiotensin system inhibitor to receive finerenone (10 or 20 mg daily) or placebo.

我们随机分配了没有糖尿病的成年慢性肾脏病患者（估算的肾小球滤过率[eGFR]，25至<90毫升/分钟/1.73平方米体表面积）和白蛋白尿患者（尿白蛋白/肌酐比值，200至≤3500，其中白蛋白以毫克计，肌酐以克计），并且正在使用肾素-血管紧张素系统抑制剂的患者，接受finerenone（每日10或20毫克）或安慰剂治疗。

The primary outcome was the total eGFR slope (mean annual rate of change in the eGFR from baseline to month 32), assessed with a two-slope linear spline mixed-effects model.

主要结果是总eGFR斜率（从基线到第32个月的eGFR平均年变化率），通过两斜率线性样条混合效应模型进行评估。

Secondary outcomes included a composite of kidney or cardiovascular events (reduction from baseline of at least 57% in the eGFR, kidney failure, hospitalization for heart failure, or death from cardiovascular causes), a composite of the two kidney events, and a composite of the two cardiovascular events.

次要结果包括肾脏或心血管事件的复合终点（基线时eGFR至少降低57%，肾衰竭，因心力衰竭住院或心血管原因死亡），两个肾脏事件的复合终点，以及两个心血管事件的复合终点。

Results

A total of 1584 participants underwent randomization - 793 were assigned to the finerenone group, and 791 to the placebo group.

共有1584名参与者进行了随机分组 - 793人被分配到非奈利酮组，791人被分配到安慰剂组。

The mean (±SD) baseline eGFR was 46.8±16.2 ml per minute per 1.73 m2 with finerenone and 46.6±16.0 ml per minute per 1.73 m2 with placebo.

基线时，使用非奈利酮的平均（±标准差）eGFR为每分钟每1.73平方米46.8±16.2毫升，使用安慰剂的为每分钟每1.73平方米46.6±16.0毫升。

The mean annual rate of change in the eGFR from baseline to month 32 was -3.3 ml per minute per 1.73 m2 (95% confidence interval[CI], -3.6 to -3.1) with finerenone and -4.0 ml per minute per 1.73 m2 (95% CI, -4.3 to -3.8) with placebo (difference, 0.7; 95% CI, 0.3 to 1.1; P<0.001).

从基线到第32个月，eGFR的平均年变化率为使用非奈利酮的每分钟每1.73平方米-3.3毫升（95%置信区间[CI]，-3.6至-3.1），使用安慰剂的为每分钟每1.73平方米-4.0毫升（95% CI，-4.3至-3.8）（差异，0.7；95% CI，0.3至1.1；P<0.001）。

Prespecified hierarchical testing showed that the risk of a composite kidney or cardiovascular outcome event was lower with finerenone than with placebo (hazard ratio, 0.77; 95% CI, 0.60 to 0.99; P = 0.04); the hazard ratiowas 0.78 (95% CI, 0.60 to 1.01) for the composite of the two kidney events and 0.60 (95% CI, 0.27 to 1.33) for the composite of the two cardiovascular events.

预先设定的分层测试显示，与安慰剂相比，使用芬瑞酮的复合肾脏或心血管结果事件风险较低（风险比，0.77；95%置信区间，0.60至0.99；P = 0.04）；复合两个肾脏事件的风险比为0.78（95%置信区间，0.60至1.01），复合两个心血管事件的风险比为0.60（95%置信区间，0.27至1.33）。

The most common adverse eventwas hyperkalemia (135 participants [17.0%] with finerenone and 105 [13.3%] with placebo); hyperkalemia events led to discontinuation of the trial regimen in 12 participants (1.5%) and 1 participant (0.1%), respectively, and to hospitalization in 7 (0.9%) and 5 (0.6%).

最常见的不良事件是高钾血症（芬瑞酮组135名参与者[17.0%]，安慰剂组105名[13.3%]）；高钾血症事件导致12名参与者（1.5%）和1名参与者（0.1%）分别停止试验方案，以及导致7名（0.9%）和5名（0.6%）住院。

Conclusions

Among adults with CKD who did not have diabetes, finerenone led to a slower decrease in the eGFR than placebo over 32 months.

在没有糖尿病的慢性肾脏病（CKD）成人患者中，与安慰剂相比，非奈利酮（finerenone）在32个月内导致估算肾小球滤过率（eGFR）下降速度更慢。

(Funded by Bayer; FIND-CKD ClinicalTrials.gov number, NCT05047263.).

（该研究由拜耳公司资助；FIND-CKD的ClinicalTrials.gov注册号为NCT05047263。）