Objective:To evaluate the efficacy and safety of Evolocumab for hypercholesterolaemia patient. Methods:Electronic databases were searched to identify all randomized controlled trials (RCTs) comparing Evolocumab and placebo for hypercholesterolaemia patients. Two authors extracted the efficacy endpoint (the percentage change from baseline in LDL-C concentration) and the safety endpoints (the incidence rates of transaminase> 3 upper limits of normal (ULN), creatinine kinase> 5 ULN, sever adverse event, discontinuation of investigational product due to adverse event) independently. Software RevMan 5.2 was utilized to perform the Meta analysis. Results:Five studies including 1396 patients were enrolled,883 patients were allocated into the Evolocumab group, and 513 into the Placebo group. Compared with the placebo group, Evolocumab reduced LDL-C [WMD=-55.04,95%CI (-57.45~52.62)] significantly (P<O.05). While the incidence rates [OR=0.57,95% CI (0.20~1.61)] of transaminase> 3 ULN, creatinine kinase> 5 ULN [OR= 2.52,95% CI (0.63-10.00)], sever adverse event [OR=1.49,95% CI (0.82~2.73, P=0.19)], discontinuation of investigational product due to adverse event [OR=1.17,95% CI (0.51~2.72)] are similar between the two groups (P>0.05). Conclusion:This meta-analysis suggests that Evolocumab is effective and safe for patients with hypercholesterolaemia. More large-sample multicenter and long-term prospective RCTs need to be applied to confirm the conclusion above. |