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非奈利酮治疗的肾脏结局:FIGARO-DKD 研究分析。

Kidney outcomes with finerenone: an analysis from the FIGARO-DKD study.

机构信息

Cardiorenal Translational Laboratory and Hypertension Unit, Institute of Research imas12, Madrid, Spain.

CIBER-CV, Hospital Universitario 12 de Octubre, Madrid, Spain.

出版信息

Nephrol Dial Transplant. 2023 Feb 13;38(2):372-383. doi: 10.1093/ndt/gfac157.

Abstract

BACKGROUND

In FIGARO-DKD, finerenone reduced the risk of cardiovascular events in patients with type 2 diabetes (T2D) and stage 1-4 chronic kidney disease (CKD). In FIDELIO-DKD, finerenone improved kidney and cardiovascular outcomes in patients with advanced CKD. This analysis further explores kidney outcomes in FIGARO-DKD.

METHODS

FIGARO-DKD (NCT02545049) included patients with urine albumin-to-creatinine ratio (UACR) 30-<300 mg/g and estimated glomerular filtration rate (eGFR) 25-90 mL/min/1.73 m2 or UACR 300-5000 mg/g and eGFR ≥60 mL/min/1.73 m2. Outcomes included two composite kidney endpoints, a composite of ≥40% decrease in eGFR from baseline sustained over ≥4 weeks, kidney failure or renal death, and a composite of ≥57% decrease in eGFR from baseline sustained over ≥4 weeks, kidney failure or renal death. Changes in albuminuria and eGFR slope were also analyzed. Kidney and CV outcomes were evaluated by baseline UACR.

RESULTS

A lower incidence rate for the eGFR ≥40% kidney composite endpoint was observed with finerenone compared with placebo, but the between-group difference was not significant [hazard ratio (HR) = 0.87; 95% confidence interval (CI): 0.76-1.01; P = .069]. A greater treatment effect was observed on the eGFR ≥57% kidney composite endpoint (HR = 0.77; 95% CI: 0.60-0.99; P = 0.041) with a 36% relative risk reduction for end-stage kidney disease. A larger magnitude of effect on kidney outcomes was observed with finerenone versus placebo for patients with severely increased albuminuria than with moderately increased albuminuria. Improvements in UACR, eGFR slope and cardiovascular risk were evident in both subgroups with finerenone.

CONCLUSIONS

The present analyses suggest that finerenone protects against kidney disease progression and cardiovascular events in patients with T2D and early- or late-stage CKD.

摘要

背景

在 FIGARO-DKD 研究中,非奈利酮降低了 2 型糖尿病(T2D)和 1-4 期慢性肾脏病(CKD)患者发生心血管事件的风险。在 FIDELIO-DKD 研究中,非奈利酮改善了晚期 CKD 患者的肾脏和心血管结局。本分析进一步探讨了 FIGARO-DKD 中的肾脏结局。

方法

FIGARO-DKD(NCT02545049)纳入了尿白蛋白与肌酐比值(UACR)为 30-<300mg/g 且估算肾小球滤过率(eGFR)为 25-90ml/min/1.73m2 或 UACR 为 300-5000mg/g 且 eGFR≥60ml/min/1.73m2 的患者。主要终点包括两个复合肾脏终点,即 eGFR 较基线下降≥40%且持续≥4 周、终末期肾病或肾脏死亡,以及 eGFR 较基线下降≥57%且持续≥4 周、终末期肾病或肾脏死亡。还分析了蛋白尿和 eGFR 斜率的变化。根据基线 UACR 评估肾脏和心血管结局。

结果

与安慰剂相比,非奈利酮降低了 eGFR≥40%肾脏复合终点的发生率,但组间差异无统计学意义[风险比(HR)=0.87;95%置信区间(CI):0.76-1.01;P=0.069]。在 eGFR≥57%肾脏复合终点上观察到更大的治疗效果(HR=0.77;95%CI:0.60-0.99;P=0.041),终末期肾病的相对风险降低了 36%。与安慰剂相比,非奈利酮对严重白蛋白尿患者的肾脏结局有更大的影响,而对中度白蛋白尿患者的影响较小。非奈利酮在两组患者中均改善了 UACR、eGFR 斜率和心血管风险。

结论

本分析表明,非奈利酮可预防 T2D 患者和早、晚期 CKD 患者的肾脏疾病进展和心血管事件。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fdb3/9923706/aca60ca7faf3/gfac157fig1g.jpg

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