Jyotsna Fnu, Mahfooz Kamran, Patel Tirath, Parshant Fnu, Simran Fnu, Harsha Fnu, Neha Fnu, Jyotishna Dev, Mishra Dipesh, Subedi Sirjana, Khatri Mahima, Kumar Satesh, Varrassi Giustino
Medicine, DR. B.R. (Bharatha Rathna) Ambedkar Medical College & Hospital, Bengaluru, IND.
Internal Medicine, Lincoln Medical Center, New York, USA.
Cureus. 2023 Jul 11;15(7):e41746. doi: 10.7759/cureus.41746. eCollection 2023 Jul.
The purpose of this study is to assess the safety and efficacy of finerenone therapy in type 2 diabetes mellitus (T2DM) patients with cardiovascular and chronic renal diseases. This meta-analysis assesses the efficacy and safety of finerenone in the treatment of diabetic kidney disease (DKD). A comprehensive search of PubMed, Embase, and Google Scholar databases was performed to identify relevant randomized controlled trials (RCTs). To quantify the effects of finerenone, the analysis included the estimation of aggregated mean differences (MDs) and relative risks (RRs), as well as 95% confidence intervals (CIs). This meta-analysis included seven double-blind trials with patients suffering from chronic kidney disease (CKD) and T2D. Participants received finerenone or a placebo was assigned at random. The primary efficacy outcomes were cardiovascular mortality, non-fatal myocardial infarction, non-fatal stroke, hospitalization for heart failure, kidney failure, a sustained 57% decrease in the estimated glomerular filtration rate from baseline over four weeks, or renal death. Among the 39,995 patients included in the analysis, finerenone treatment was associated with a lower risk of cardiovascular and renal-related mortality compared to placebo (RR = 0.86 (0.80, 0.93), p = 0.0002; I-squared statistic (I ) = 0%) and (RR = 0.56 (0.17, 1.82), p = 0.34; I= 0%). In addition, finerenone treatment was associated with a marginally reduced risk of serious adverse events (RR = 0.95 (0.92, 0.97), p = 0.0001; I= 0%), although no significant difference in the overall risk of adverse events was observed between the two groups (RR = 1.00 (0.99, 1.01), p = 0.56; I= 0%). This study's findings suggest that finerenone administration can reduce the risk of end-stage kidney disease, renal failure, cardiovascular mortality, and hospitalization. Patients with both T2DM and CKD are therefore advised to consider finerenone therapy.
本研究的目的是评估非奈利酮治疗对患有心血管疾病和慢性肾病的2型糖尿病（T2DM）患者的安全性和有效性。本荟萃分析评估了非奈利酮治疗糖尿病肾病（DKD）的有效性和安全性。对PubMed、Embase和谷歌学术数据库进行了全面检索，以确定相关的随机对照试验（RCT）。为了量化非奈利酮的效果，分析包括汇总平均差（MD）和相对风险（RR）的估计，以及95%置信区间（CI）。本荟萃分析纳入了七项针对慢性肾病（CKD）和T2D患者的双盲试验。参与者被随机分配接受非奈利酮或安慰剂。主要疗效结局包括心血管死亡率、非致命性心肌梗死、非致命性中风、因心力衰竭住院、肾衰竭、四周内估计肾小球滤过率较基线持续下降57%或肾脏死亡。在纳入分析的39995名患者中，与安慰剂相比，非奈利酮治疗与心血管和肾脏相关死亡率较低相关（RR = 0.86（0.80，0.93），p = 0.0002；I² 统计量（I²）= 0%）和（RR = 0.56（0.17，1.82），p = 0.34；I² = 0%）。此外，非奈利酮治疗与严重不良事件风险略有降低相关（RR = 0.95（0.92，0.97），p = 0.0001；I² = 0%），尽管两组之间在不良事件总体风险上未观察到显著差异（RR = 1.00（0.99，1.01），p = 0.56；I² = 0%）。本研究结果表明，使用非奈利酮可降低终末期肾病、肾衰竭、心血管死亡率和住院风险。因此，建议同时患有T2DM和CKD的患者考虑非奈利酮治疗。
