| Summary: | <b>Purpose:</b> Cytochrome P450 (CYP) is involved in the metabolism of statins; CYP3A5 is the main enzyme responsible for lipophilic statin metabolism. However, the evidence of the association between <i>CYP3A5*3</i> polymorphism and the risk of statin-induced adverse events remains unclear. Therefore, this study aimed to perform a systematic review and meta-analysis to investigate the relationship between the <i>CYP3A5*3</i> polymorphism and the risk of statin-induced adverse events. <b>Methods:</b> The PubMed, Web of Science, and EMBASE databases were searched for qualified studies published until August 2020. Observational studies that included the association between statin-induced adverse events and the <i>CYP3A5*3</i> polymorphism were reviewed. The odds ratios (ORs) and 95% confidence intervals (CIs) were evaluated to assess the strength of the relationship. The Mantel–Haenszel method was used to provide the pooled ORs. Heterogeneity was estimated with I<sup>2</sup> statistics and publication bias was determined by Begg’s and Egger’s test of the funnel plot. Data analysis was performed using Review Manager (version 5.4) and R Studio (version 3.6). <b>Results:</b> In total, data from 8 studies involving 1614 patients were included in this meta-analysis. The <i>CYP3A5*3</i> polymorphism was found to be associated with the risk of statin-induced adverse events (*3/*3 vs. *1/*1 + *1/*3: OR = 1.40, 95% CI = 1.08–1.82). For myopathy, the pooled OR was 1.30 (95% CI: 0.96–1.75). The subgroup analysis of statin-induced myopathy revealed a trend, which did not achieve statistical significance. <b>Conclusions:</b> This meta-analysis demonstrated that the <i>CYP3A5*3</i> polymorphism affected statin-induced adverse event risk. Therefore, <i>CYP3A5</i> genotyping may be useful to predict statin toxicity.
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