Efficacy And Safety Of Evolocumab In Patients With Type 2 Diabetes And Dyslipidaemia: A Meta-analysis

Objective: To assess the efficacy and safety of PCSK9 antibody Evolocumab in patients with type 2 diabetes mellitus and dyslipidaemia on lipidlowering by a Meta-analysis.Methods: Pubmed,Embase,the Cochrane Library,CNKI and CBM databases(up to April 1,2020)were searched for phase 2 and 3 randomized controlled trials(RCTs)about Evolocumab with placebo in patients with type 2diabetes and dyslipidaemia.According to the method provided by Cochrance handbook,the research literatures that meet the standards were screened.Perform quality assessment on the included literature and extract relevant data on efficacy and safety.The Rev Man5.1 software was used for Meta-analysis of the collected data.Results: Two Phase 3 clinical trials involving 913 patients who at least one dose of study drug(Evolocumab or placebo)were included,all literatures were published by English.The results of Meta-analysis showed that: first,the efficacy evaluation including LDL-C,non-HDL-C,Lp(a),TC,TG and HDL-C improved significantly with Evolocumab in people with type 2 diabetes compared to placebo(P<0.05).secondly,the security analysis including there were statistical differences in serious adverse events(P<0.05)and no significant differences in hypertension,nasopharyngitis,back pain,headache,upper respiratory tract infection,urinary tract infection,CK>5 UIN and ALT or AST>3 UIN during the experiment(P>0.05).The last,there was no significant change in baseline FPG and Hba1 c between patients treated with Evolocumab and placebo.Conclusion: Existing clinical trial data show that Evolocumab can significantly reduce LDL-C levels and improve other blood lipid indicators,with no significant impact glycaemic measures and good security.