Tehran University of Medical Sciences Iranian Journal of Public Health 2251-6085 52 5 2023 05 07 903 912 Liming Zhao Department of Vascular Surgery, Liu Zhou People’s Hospital, Guangxi, 545006, China Ying Liu Department of Endocrinology, Affiliated Hospital of Youjiang Medical University for Nationalities, Guangxi, China Ziting Cao Department of Vascular Surgery, Liu Zhou People’s Hospital, Guangxi, 545006, China Jun Wang Department of Vascular Surgery, Liu Zhou People’s Hospital, Guangxi, 545006, China Xin Huo Department of Vascular Surgery, Liu Zhou People’s Hospital, Guangxi, 545006, China 2022 11 07 2023 01 22 Background: Proprotein convertase subtilisin / Kexin type 9 (PCSK9) inhibitors are efficacious lipid-lowering agents. This drug is related to improving the prognosis of patients with cardiovascular disease (CVD). The purpose of this meta-analysis was to systematically analyze the safety and efficacy of PCSK9 inhibitors in all published randomized controlled trials (RCTs). Methods: As of October 25, 2021, we searched PubMed, EMBASE, MEDLINE, Cochrane Library and web of science. Results: From 684 articles, we included 11 trials for meta-analysis, including 52511 participants (26938 in the PCSK9 inhibitor group and 25573 in the control group). In terms of effectiveness, PCSK9 inhibitors reduced the risk of major adverse cardiovascular events(MACE) (OR=0.89, 95% Cl: 0.83-0.95, P=0.0009), but did not significantly reduce the risk of cardiovascular death (OR=0.95, 95% Cl: 0.84-1.07, P=0.38) or all-cause death (OR=0.93, 95% Cl: 0.85-1.03, P=0.18); In terms of safety, PCSK9 did not increase the risk of treatment-emergent adverse events (TEAE)(OR=0.98, 95% Cl: 0.94-1.02, P=0.28). Conclusion: PCSK9 inhibitors can significantly reduce the risk of MACE in patients with high cardiovascular risk, which is well tolerated, but the impact on the risk of death is unclear.   https://ijph.tums.ac.ir/index.php/ijph/article/view/30305 https://ijph.tums.ac.ir/index.php/ijph/article/download/30305/7925