Objective To conduct a systematic meta-analysis of the risk of ketoacidosis(DKA)in adults with type 2 diabetes mellitus(T2DM)caused by SGLT-2 inhibitors.Methods Randomized controlled trials(RCT)of SGLT-2 inhibitors in adults with T2DM included in PubMed,Embase and Cochrane Library were searched from the establishment of the data-bases to December 31,2023.Data such as sample size,age of subjects,body mass index,occurrence of DKA,type and time of hypoglycemic drugs used were extracted.Revman 5.4 software was used for meta-analysis.The risk ratio(RR)value and 95％CI were used as effect variables for dichotomous variables.Results A total of 26 RCT involving 65176 T2DM patients were included,including 37021 T2DM patients in the SGLT-2 group and 28155 T2DM patients in the control group,and 139 DKA events occurred.The incidence of DKA events in the SGLT-2 group was 0.29％(106/37021),while in the control group it was 0.12％(33/28155).Compared with the control group,SGLT-2 group had a higher risk of DKA(RR=2.71,95％CI 1.84～3.97,P＜0.001).Subgroup analysis showed that T2DM patients with age＞60 years(RR=2.73,95％CI 1.84～4.05,P＜0.001),body mass indexe3 1 kg/m2(RR=2.73,95％CI 1.82～4.07,P＜0.001)and medication duration＞52 weeks(RR=2.73,95％CI1.84～4.05,P＜0.001)who received SGLT-2 inhibitors had a higher risk ofDKA compared with their respective control groups.In the subgroups of drug types,the risk ofDKA was higher in canagliflozin(RR=4.82,95％CI 1.70～13.64,P=0.003)and ertugliflozin(RR=4.10,95％CI1.11～1520,P=0.040)than in the control group.Conclusions SGLT-2 inhibi-tors can increase the risk of DKA in adults with T2DM.Moreover,the older the age,the higher body mass index,and the longer the duration of receiving SGLT-2 inhibitors,the higher the risk of developing DKA,and the risk of DKA is also relat-ed to the type of medication.
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