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

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.