Meta-analysis Of The Long-term Safety Of Empagliflozin In The Treatment Of Type 2 Diabetes Melitus

Background:The incidence of type 2 diabetes has been increasing year by year.As one of the SGLT-2 inhibitors,empagliflozin has outstanding efficacy in blood glucose control and cardio-kidney protection due to its specific mechanism,but there is still a lack of long-term safety evaluation on its use.Objective:Systematic evaluation of the long-term safety of empagliflozin in the treatment of type 2 diabetes patients.Method:CNKI,Pub Med,Embase,Cochrane Library,Wanfang and other databases were searched from January 2014 to November 2020.RCTs were included.After literature screening and quality assessment,Rev Man5.3 software was used for data analysis.Results:Ten RCT studies involving 12,704 patients were included in this study.In addition to the background treatment,the trial group received either empagliflozin10 mg or 25 mg,and the control group received placebo for a treatment period of ≥52weeks.Results of the Meta-analysis showed that the incidence of serious adverse events was significantly lower in the long-term use of empagliflozin compared with placebo in both the overall analysis and subgroup analysis(P<0.05).There was no significant difference in the overall incidence of adverse events,hypoglycemia,nasopharyngitis,upper respiratory tract infection,and urinary tract infection compared with placebo(all P<0.05),but the incidence of reproductive system infection was significantly increased(P<0.00001).There was no significant difference in all-cause mortality between empagliflozin 10 mg and placebo(P<0.05),and empagliflozin 25 mg was associated with a lower all-cause mortality than placebo(P<0.05).The incidence of overall adverse events,serious adverse events,hypoglycemia,nasopharyngitis,upper respiratory tract infection,urinary tract infection,reproductive system infection and all-cause death were similar between empagliflozin 10 mg and empagliflozin 25 mg,without statistical significance(all P≥0.05).Conclusion:1.Compared with placebo,long-term use of empagliflozin can reduce the incidence of serious adverse events,and do not increase overall adverse events in patients with type 2 diabetes,hypoglycemia,nasopharyngitis,the incidence of upper respiratory tract infection,urinary tract infections,may reduce the incidence rate for all-cause mortality,but will increase significantly in reproductive system infection.2.The incidence of adverse drug events or reactions was similar between 10 mg and 25 mg of empagliflozin,suggesting that the increase of the therapeutic dose of empagliflozin from 10 mg to 25 mg does not increase the incidence of adverse drug events or reactions.