| AIMS: To Systematically evaluate therapeutic efficacy and safety of long-acting glucagon like peptide-1 receptor agonist(GLP-1 RA)Exenatide vs.Other glucose-lowering drugs or placebo in the treatment of type 2 diabetes mellitus.METHODS: Retrieved from Pubmed,Clinical Trial,Embase,Medline,Cochrane Library,Wanfang Data,CNKI(China National Knowledge Infrastructure)etc.randomized controlled trials(RCT)about Exenatide(trial group)vs.other glucose-lowering drugs or placebo(control group)in the treatment of T2 DM who were selected during the establishment of database to Jan.2019.After data extraction and quality evaluation with Cochrane system evaluator manual 5.1.0,mata-analysis was performed for Hb A1 c level and compliance rate,fasting plasma glucose(FPG)level,postprandial blood glucose(PBG),body weight,systolic blood pressure(SBP),diastolic blood pressure(DBP),heart rate(HR),blood lipid and other effective indicators and the incidence of hypoglycemia events,gastrointestinal reactions,injection-site related adverse events and other safety indicators by using Rev Man 5.3 software and STATA 12.0 software.According to the different types of drugs,the control group were divided into other GLP-1 RA group(group A)and drug group other than GLP-1 RA group(group B),and performed subgroup analysis.RESULTS: A total of 15 RCTs involving 7 868 patients were included.The results of Meta-analysis showed that compared with control group,trial group could effectively increase compliance rate of Hb A1c<7% [RD=0.10,95%CI(0.03,0.17),P=0.007] and Hb A1c<6.5% [RD=0.06,95%CI(0.04,0.08),P<0.001],decrease the levels of Hb A1 c [MD=-0.20,95%CI(-0.36,-0.04),P=0.02],at the same time,decrease the level of CHOL [MD=-0.12,95%CI(-0.24,0.00),P=0.04] and LDL [MD=-0.10,95%CI(-0.18,-0.01),P=0.02],increase heart rates [MD=1.84,95%CI(0.75,2.93),P<0.001],the subgroup analysis shows that compared with B group,trial group could effectively decrease body weight,and the difference was statistically significant.The major adverse drug reactions of Ex QW were gastrointestinal reaction;the incidence of gastrointestinal reaction was no statistical difference between trial group and control group [RD=0.09,95%CI(0.00,0.18),P=0.06],subgroup analysis shows that the incidence of gastrointestinal reaction was significantly lower than A group [RD=-0.21,95%CI(-0.28,-0.14),P<0.001] and higher than B group [RD=0.18,95%CI(0.11,0.25),P<0.001],the gastrointestinal reaction incidance of nausea and vomiting are significantly lower than A group [RD=-0.12,95%CI(-0.14,-0.09),P<0.001],[RD=-0.04,95%CI(-0.06,-0.02),P<0.001],there is no statistical difference between trial group and A group in diarrhea [RD=-0.03,95%CI(-0.07,0.02),P=0.25];the incidence of hypoglycemia events of experimental group was significantly lower than control group [RD=-0.01,95%CI(-0.03,0.00),P=0.02];the incidence of injection-site related adverse events of experimental group was significantly higher than control group[RD=0.08,95%CI(0.05,0.11),P<0.001],and hihger than A group,insulin glargine and placebo[RD=0.10,95%CI(0.05,0.15),P<0.001]、[RD=0.15,95%CI(0.04,0.27),P=0.008]、[RD=0.04,95%CI(0.02,0.07),P<0.001];it has no significant difference between the trial group and the control group with severe adverse event(AEs),headache,upper respiratory infection and nasopharyngitis [RD=-0.01,95%CI(-0.02,0.00),P=0.08],[RD=0.00,95%CI(-0.01,0.01),P=0.91],[RD=-0.01,95%CI(-0.03,0.02),P=0.56] and [RD=-0.01,95%CI(-0.02,0.01),P=0.48].CUNCLUTIONS: Ex QW can effectively reduce the level of Hb A1 c and improve the compliance rate of T2 DM patients,reduce body mass,cholesterol and low-density lipoprotein levels,and slightly reduce blood pressure.The hypoglycemia events was low,and the gastrointestinal reactions was lower than other GLP-1 RA,but the incidence of injection-site related adverse events was high. |
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