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Meta-analysis of the Safety and Efficacy of Finerenone in the Treatment of Type 2 Diabetic Nephropathy

  

  1. School of Life Sciences and Biopharmaceuticals,Shenyang Pharmaceutical University,Shenyang 110000,China
  • Received:2024-08-20 Accepted:2024-11-13
  • Contact: CHENG Gang,Professor/Doctoral supervisor

非奈利酮治疗2型糖尿病肾病安全性和有效性的Meta分析

  

  1. 110000 辽宁省沈阳市,沈阳药科大学生命科学与生物制药学院
  • 通讯作者: 程刚,教授,博士研究生导师

Abstract: Background Finerenone,a nonsteroidal mineralocorticoid antagonist,is a novel therapeutic agent for renal protection in patients with diabetic kidney disease,joining the ranks of angiotensin-converting enzyme inhibitors and sodium-glucose cotransporter 2 inhibitors in providing renal protection for such patients. Recently,two meta-analyses focusing on patients with chronic kidney disease have yielded conflicting conclusions regarding the impact of finerenone on the decline of estimated glomerular filtration rate(eGFR). In light of this,the present meta-analysis specifically targets the population with type 2 diabetes,aiming to thoroughly investigate the efficacy and safety of finerenone. Objective To systematically evaluate the efficacy and safety of finerenone in patients with type 2 diabetes and kidney disease. Methods A computerized search was conducted in the Cochrane,Web of Science,Embase,and PubMed databases,covering the period from their inception to April 2024. Literature was screened and data extracted according to the inclusion and exclusion criteria. Meta-analysis was performed using Revman 5.3,comparing indicators such as the urine albumin-to-creatinine ratio and estimated glomerular filtration rate in type 2 diabetes patients treated with finerenone. Results A total of 7 articles were ultimately included,involving 15,528 patients. The results showed that compared with the control group,intervention group(using finerenone)had statistically significant differences in the urine albumin-to-creatinine ratio(SMD=-0.46,95%CI=-0.48 to -0.39,P<0.05),estimated glomerular filtration rate (SMD=-0.15,95%CI=-0.19 to -0.10,P<0.05),renal composite endpoint (OR=0.83,95%CI=0.75 to 0.92,P<0.05),all-cause mortality(OR=0.88,95% CI=0.78 to 0.99,P<0.05),and end-stage renal disease(OR=0.88,95% CI=0.78 to 0.99,P<0.05). Compared with the control group,intervention group significantly increased the risk of hyperkalemia(OR=2.13,95%CI=1.89 to 2.39,P<0.05).Conclusion Finerenone can significantly improve renal composite endpoint events in patients with type 2 diabetes and kidney disease,reduce the urine albumin-to-creatinine ratio,and slow down the decline of eGFR;however,attention should be paid to the risk of hyperkalemia during treatment.

Key words: Finerenone, Diabetic nephropathies, Safety, Efficacy, Meta-analysis

摘要: 背景 非甾体类盐皮质激素拮抗剂非奈利酮是用于保护糖尿病肾病患者肾脏的新药,与血管紧张素转换酶抑制剂和钠-葡萄糖共转运蛋白2抑制剂均为糖尿病肾病患者的肾脏保护药物。近期,两项针对慢性肾病患者型荟萃分析,关于非奈利酮对估算肾小球滤过率下降的影响,得出了截然相反的结论。鉴于此,本研究专门聚焦于2型糖尿病患者,旨在深入探究非奈利酮的有效性和安全性。目的 系统评价非奈利酮在2型糖尿病肾病患者中的有效性和安全性。方法 计算机检索Cochrane、Web of Science、Embase和PubMed数据库,检索时间为建库至2024年4月。按照纳入与排除标准筛选文献、提取数据,采用Revman5.3进行Meta分析,对应用非奈利酮治疗的2型糖尿病患者的尿白蛋白/肌酐比率、估算肾小球滤过率等指标进行比较。结果 最终纳入7篇文献,共包括15 528例患者。结果显示,干预组(使用非奈利酮)患者尿白蛋白/肌酐比率(SMD=-0.46,95%CI=-0.48~-0.39,P<0.05)、估算肾小球滤过率(SMD=-0.15,95%CI=-0.19~-0.10,P<0.05)、肾脏复合终点(OR=0.83,95%CI=0.75~0.92,P<0.05)、全因死亡率(OR=0.88,95%CI=0.78~0.99,P<0.05)和终末期肾病(OR=0.88,95%CI=0.78~0.99,P<0.05)与对照组比较,差异均有统计学意义。与对照组相比,干预组组高钾血症的风险显著增加(OR=2.13,95%CI=1.89~2.39,P<0.05)。结论 非奈利酮能显著改善2型糖尿病肾病患者肾脏复合终点事件,降低尿白蛋白/肌酐比率并减缓eGFR下降;治疗时需注意高钾血症的风险。

关键词: 非奈利酮, 糖尿病肾病, 安全性, 有效性, Meta 分析

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