Meta-analysis of the Efficacy and Safety of PCSK9 Inhibitors in the Treatment of Atherosclerotic Cardiovascular Disease

Xiang Zhao ； Yun Lu

《Frontiers in Economics and Management》 2卷6期 (2021/06) Pp. 35-40

https://doi.org/10.6981/FEM.202106_2(6).0008

摘要

Background: Proprotein convertase subtilisin/kexin type 9(PCSK9) inhibitors have been proven to be effective lipid-lowering agents, but for patients with atherosclerotic cardiovascular disease (ASCVD), their impact on the outcome of cardiovascular events is still not clear enough, so as its adverse events. We evaluated the efficacy and safety of PCSK9 inhibitors in the treatment of ASCVD through systematically reviewing and meta-analyzing randomized controlled trials. Methods: We searched Pubmed, Embase, Medline, Cochrane Library, CNKI, Wanfang Database, Chinese Biomedical Literature Database (CBM), screened articles, and meta-anlysised the outcomes on efficiency and safety aspect. Results: 9 RCT with a total of 53386 patients were included from 449 articles. Meta-analysis showed: (1) In the context of basic statin therapy, PCSK9 inhibitors can significantly reduce the incidence of major cardiovascular adverse events (MACE) compared with placebo [OR=0.83,95%CL(0.79,0.88), P＜0.001]. and two individual components of MACE, non-fatal myocardial infarction [OR=0.79,95%CL (0.73,0.85), P＜0.001], stroke [OR=0.79, 95%CL(0.73,0.85). But all-coused and cardiovascular death [OR=0.95, 95% CL (0.84, 1.08), P=0.43], unstable angina [OR=0.90, 95% CL (0.77, 1.07), P=0.23] had no significant difference. (2) Compared with placebo, PCSK9 inhibitor didnot increase the occurance of adverse reactions [OR=0.99,95%CL (0.90,1.09), P=0.88] and serious adverse reactions [OR=0.96,95%CL(0.92-1.00), P=0.06]. The use of PCSK9 inhibitors only increased minor adverse reactions, such as injection site reactions [OR=1.86, 95%CL (1.40, 2.47), P＜0.001] and pain in extremity [OR=1.47, 95%CL (1.14-1.91), P=0.003], so as new diabetes, allergies, and neurocognitive events. Conclusion: PCSK9 inhibitors can effectively reduce the occurrence of cardiovascular adverse events without increasing the occurrence of adverse reactions and serious adverse reactions when used in ASCVD patients and on statin background therapy.

關鍵字

Proprotein Convertase Subtilisin/Kexin Type 9 Inhibitor ； Atherosclerotic Cardiovascular Disease ； Meta Analysis

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