Efficacy and safty of Evolocumab in treatment of dyslipidemia: a meta-analysis
SU Ting
WANG Zhi-lu
QIAN Xuan-kun
ZHANG Pan-xiao
FENG Xia-long
Abstract：Objective To systemically evaluate the efficacy and safety of Evolocumab with in treatment of dyslipidemia.Methods The computer search including PubMed, EMbase, the Cochrane Library, ClinicalTrial.gov, CBM and CNKI were conducted to collect the randomized controlled trials (RCTs) for Evolocumab in treatment of dyslipidemia, the retrieval period was from the database establishment until September 2015. Two reviewers identified the literatures independently according to inclusion and exclusion criteria, extracted the information and evaluated the quality of assessment methods of each study, then Meta-analysis was performed by RevMan 5.2 software.Results A total of 11 RCTs comprising 9500 subjects were enrolled. Compared with placebo, Evolocumab 420 mg once every 4 weeks (Q4W) subcutaneous injection significantly reduced LDL-C by 56.38% (95%CI:61.54~51.22,P<0.05), Evolocumab 140 mg Q2W reduced low-density lipoprotein cholesterol (LDL-C) by 60.54% (95%CI:68.15~52.94, P<0.05). It also could significantly reduce total cholesterol (TC), non-high-density lipoprotein cholesterol (Non-HDL-C), Very low density lipoprotein cholesterol (VLDL-C), triglyceride (TG), lipoprotein-a and Apolipoprotein B (ApoB). And it also increased high-density lipoprotein cholesterol (HDL-C) and apolipoprotein A1 (ApoA1) significantly. In safety analysis, there were no difference between Evolocumab and placebo in SAEs and leading to discontinuation (P>0.05). The most common adverse events are nasopharyngitis, upper respiratory tract infection, back pain, injection-site reaction, headache, myalgia and diarrhea, the analysis results showed that there was no significant difference between the two groups(P>0.05). For Alanine transaminase (ALT) or aspartate aminotransferase (AST)>3 upper limit of normal (ULN), there was no significant difference between the two groups (P>0.05), but on Treatment-emergent adverse events (TEAE), creatine kinase (CK)>5ULN, there was significant difference between the two groups (P<0.05).Conclusion Evolocumab resulted in a significant improvement in lipid parameters, but showed no significant difference in common adverse events while comparing with placebo. More high quality randomized controlled trials with large sample sizes are need to further validate this result in the future.
Keywords：EvolocumabLDL-CMeta-analysisRandomized controlled trials
Publication Date：2017-01-01
Online Publishing Date：2025-08-15(First online date of this platform, not the publication date of the document)
Pages：7( 149-154,158 )