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inclisiran对低密度脂蛋白胆固醇和枯草杆菌蛋白酶/kexin 9型前蛋白转化酶调节作用的Meta分析

A Meta-analysis of the Regulation of Low-Density Lipoprotein Cholesterol and Proprotein Convertase Subtilisin-Kexin Type 9 with Inclisiran.

作者信息

Li Yihan, Xue Kefan, Hu Rui, Hu Xiao, Guo Ran, Guo Hongxia, Li Gang

机构信息

Graduate School of Hebei Medical University, Shijiazhuang, Hebei, China.

Division of Cardiology, Institute of Geriatric Diseases, Hebei General Hospital, Shijiazhuang, Hebei, China.

出版信息

Am J Cardiovasc Drugs. 2025 Mar;25(2):191-201. doi: 10.1007/s40256-024-00702-z. Epub 2024 Nov 29.

Abstract

OBJECTIVE

This study aimed to systematically evaluate the regulation of low-density lipoprotein cholesterol (LDL-C) and proprotein convertase subtilisin-kexin type 9 (PCSK9) with inclisiran using a meta-analysis.

METHODS

A comprehensive search of PubMed, Embase, the Cochrane Library, and Web of Science was conducted for randomized controlled trials of inclisiran published up to April 2024. Stata software was used for statistical analysis of outcome indicators from the included studies. Egger's test was employed to assess the risk of publication bias.

RESULTS

A total of 10 studies involving 5208 participants were included in this meta-analysis. The results indicated that inclisiran significantly reduced LDL-C levels (weighted mean difference [WMD] - 48.17%; 95% confidence interval [CI] - 51.78 to - 44.56%; P < 0.01) and PCSK9 levels (WMD - 77.91%; 95% CI - 82.99 to - 72.84; P < 0.01) compared with the control group. The incidence of adverse reactions in the inclisiran group did not differ significantly from that in the placebo group (relative risk [RR] 1.03; 95% CI 0.99-1.09; P = 0.15). Similarly, there was no significant difference in the incidence of cardiovascular adverse events between the inclisiran and placebo groups (RR 0.92; 95% CI 0.74-1.16; P = 0.49). Sensitivity analysis showed that the exclusion of any single study did not significantly affect the final results.

CONCLUSION

Current evidence suggests that inclisiran significantly lowers LDL-C and PCSK9 levels. The incidence of adverse events and cardiovascular adverse events was not significantly different from that with other drugs.

摘要

目的

本研究旨在通过荟萃分析系统评价inclisiran对低密度脂蛋白胆固醇(LDL-C)和前蛋白转化酶枯草溶菌素9型(PCSK9)的调节作用。

方法

全面检索了截至2024年4月发表的关于inclisiran的随机对照试验的PubMed、Embase、Cochrane图书馆和Web of Science。使用Stata软件对纳入研究的结局指标进行统计分析。采用Egger检验评估发表偏倚风险。

结果

本荟萃分析共纳入10项研究,涉及5208名参与者。结果表明,与对照组相比,inclisiran显著降低了LDL-C水平(加权平均差[WMD]-48.17%;95%置信区间[CI]-51.78至-44.56%;P<0.01)和PCSK9水平(WMD-77.91%;95%CI-82.99至-72.84;P<0.01)。inclisiran组的不良反应发生率与安慰剂组相比无显著差异(相对风险[RR]1.03;95%CI 0.99-1.09;P=0.15)。同样,inclisiran组和安慰剂组之间心血管不良事件的发生率也无显著差异(RR 0.92;95%CI 0.74-1.16;P=0.49)。敏感性分析表明,排除任何一项单独研究均未显著影响最终结果。

结论

目前的证据表明,inclisiran可显著降低LDL-C和PCSK9水平。不良事件和心血管不良事件的发生率与其他药物相比无显著差异。

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