Finerenone in Patients with Chronic Kidney Disease and Type 2 Diabetes: The FIDELIO-DKD Subgroup from China.

IF 3.4 Q2 Medicine Psychosomatics Pub Date : 2023-08-08 eCollection Date: 2023-12-01 DOI:10.1159/000531997

Haitao Zhang, Jingyuan Xie, Chuanming Hao, Xuemei Li, Dalong Zhu, Hongguang Zheng, Xudong Xu, Zhaohui Mo, Weiping Lu, Yibing Lu, Chaoqing Wu, Nanwei Tong, Li Wang, Zhihong Liu

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Abstract

Background: This prespecified subgroup analysis of the FIDELIO-DKD trial aimed to evaluate the efficacy and safety of finerenone in patients with chronic kidney disease (CKD) and type 2 diabetes mellitus (T2DM) in China.

Methods: 372 participants were recruited from 67 centers in China and randomized 1:1 to oral finerenone or placebo with standard therapy for T2DM. The primary composite outcome included kidney failure, sustained decrease of estimated glomerular filtration rate ≥40% from baseline over at least 4 weeks, or renal death. The key secondary composite outcome included death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure.

Results: After a median follow-up of 30 months, the finerenone group showed a relative risk reduction (RRR) of 41% (hazard ratio [HR] = 0.59, 95% confidence interval [CI], 0.39-0.88; p = 0.009) for the primary composite outcome compared with placebo, consistent across its components with treatment benefits with finerenone. Based on an absolute between-group difference of 12.2% after 30 months, the number of patients who needed to be treated with finerenone to prevent one primary outcome event was eight (95% CI: 4-84). For the key secondary composite outcome, the finerenone group showed a RRR of 25% (HR = 0.75, 95% CI, 0.38-1.48; p = 0.408). Adverse events were similar between the two groups. The effects of finerenone on blood pressure were modest. No gynecomastia events were reported in the study. Hyperkalemia leading to discontinuation occurred in eight (4.3%) and two (1.1%) participants in the finerenone and control groups, respectively. The incidence of acute kidney injury was comparable between the two groups (1.6% vs. 1.6%).

Conclusions: Finerenone resulted in lower risks of CKD progression than placebo and a balanced safety profile in Chinese patients with CKD and T2DM.

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慢性肾脏病合并 2 型糖尿病患者的非格列酮治疗：中国的 FIDELIO-DKD 亚组。

研究背景方法：从中国的67个中心招募了372名参与者，按1:1的比例随机分配到口服非格列酮或安慰剂以及T2DM的标准疗法中。主要综合结果包括肾衰竭、至少 4 周内估计肾小球滤过率较基线持续下降≥40% 或肾性死亡。主要的次要综合结果包括心血管原因导致的死亡、非致命性心肌梗死、非致命性中风或因心力衰竭住院：中位随访30个月后，与安慰剂相比，非格列酮组的主要综合结果相对风险降低了41%（危险比[HR] = 0.59，95%置信区间[CI]，0.39-0.88；P = 0.009），与非格列酮的治疗获益相一致。根据30个月后12.2%的组间绝对差异计算，需要使用非格列酮治疗才能预防一次主要结果事件的患者人数为8人（95% CI：4-84）。在关键的次要综合结果方面，非格列酮组的 RRR 为 25%（HR = 0.75，95% CI，0.38-1.48；P = 0.408）。两组的不良反应相似。非格列酮对血压的影响不大。研究中未报告妇科炎症事件。在非奈酮组和对照组中，分别有 8 名（4.3%）和 2 名（1.1%）参与者因出现高钾血症而停药。两组的急性肾损伤发生率相当（1.6% 对 1.6%）：结论：与安慰剂相比，非格列酮能降低中国慢性肾脏病和T2DM患者的慢性肾脏病进展风险，且安全性均衡。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Psychosomatics 医学-精神病学

CiteScore

3.20

自引率

0.00%

发文量

审稿时长

6-12 weeks

期刊介绍： The mission of Psychosomatics is to be the leading psychiatry journal focused on the care of patients with comorbid medical and psychiatric illnesses. The scope of Psychosomatics includes original research, review articles and clinical reports that address psychiatric aspects of medical illnesses and their management. Areas of particular interest include: the effect of co-morbid psychiatric conditions on the management of medical illness; the psychiatric management of patients with comorbid medical illness; educational content for physicians and others specializing in consultation-liaison (C-L) psychiatry; and, the provision of psychiatric services to medical populations, including integrated care.