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非奈利酮与卡格列净对慢性肾脏病合并2型糖尿病患者的疗效比较:匹配调整间接比较

Comparative Efficacy of Finerenone versus Canagliflozin in Patients with Chronic Kidney Disease and Type 2 Diabetes: A Matching-Adjusted Indirect Comparison.

作者信息

Cherney David, Folkerts Kerstin, Mernagh Paul, Nikodem Mateusz, Pawlitschko Joerg, Rossing Peter, Hawkins Neil

机构信息

Department of Medicine, Division of Nephrology, University Health Network, Toronto, ON M5G 2C4, Canada.

Bayer AG, 42117 Wuppertal, Germany.

出版信息

J Mark Access Health Policy. 2024 Jul 25;12(3):169-180. doi: 10.3390/jmahp12030014. eCollection 2024 Sep.

Abstract

This study aimed to close an evidence gap concerning the relative efficacy of finerenone versus SGLT2is in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D). Canagliflozin was selected as a proxy for the SGLT2i class. Patient-level data of two randomized controlled trials (RCTs) of finerenone (FIDELIO-DKD and FIGARO-DKD) were used alongside aggregated data from CREDENCE, an RCT of canagliflozin. To account for meaningful between-study heterogeneity between each finerenone trial and CREDENCE, a matching-adjusted indirect comparison of a range of efficacy outcomes was undertaken for each finerenone study versus CREDENCE. These results were meta-analyzed, enabling the estimation of the relative effects of finerenone against canagliflozin. For the cardiorenal composite endpoint, the hazard ratio (HR) comparing finerenone to canagliflozin was 1.07 (95% CI: 0.83 to 1.36). The corresponding HRs for all-cause mortality, end-stage kidney disease and cardiovascular death were 0.99 (95% CI: 0.73 to 1.34), 1.03 (95% CI: 0.68 to 1.55) and 0.94 (95% CI: 0.64 to 1.37), respectively. The absence of statistically significant differences was consistent throughout the main analysis and a range of sensitivity analyses. Based on this study, using a large sample of data and adjusted for meaningful differences between the baseline characteristics of the included RCTs, there was no statistically significant evidence indicating a difference in the efficacy of finerenone compared to canagliflozin in the treatment of CKD in patients with T2D.

摘要

本研究旨在填补关于非奈利酮与钠-葡萄糖协同转运蛋白2抑制剂(SGLT2i)在慢性肾脏病(CKD)合并2型糖尿病(T2D)患者中相对疗效的证据空白。选择卡格列净作为SGLT2i类药物的代表。使用了非奈利酮两项随机对照试验(RCT)(FIDELIO-DKD和FIGARO-DKD)的患者水平数据以及卡格列净RCT(CREDENCE)的汇总数据。为了解决每项非奈利酮试验与CREDENCE之间有意义的研究间异质性,对每项非奈利酮研究与CREDENCE进行了一系列疗效结局的匹配调整间接比较。对这些结果进行了荟萃分析,从而能够估计非奈利酮相对于卡格列净的相对效应。对于心肾复合终点,非奈利酮与卡格列净比较的风险比(HR)为1.07(95%CI:0.83至1.36)。全因死亡率、终末期肾病和心血管死亡的相应HR分别为0.99(95%CI:0.73至1.34)、1.03(95%CI:0.68至1.55)和0.94(95%CI:0.64至1.37)。在整个主要分析和一系列敏感性分析中,均未发现统计学显著差异。基于本研究,使用大量数据样本并针对纳入RCT基线特征之间的有意义差异进行调整后,没有统计学显著证据表明在T2D患者CKD治疗中,非奈利酮与卡格列净的疗效存在差异。

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