Diabetes Metab Res Rev. 2014 May;30(4):269-83. doi: 10.1002/dmrr.2494.
The aim of the present meta-analysis was to assess the safety profile of dipeptidyl peptidase-4 (DPP-4) inhibitors and sodium-glucose cotransporter 2 (SGLT-2) inhibitors in comparison with placebo as add-on to metformin therapy in patients with type 2 diabetes. Randomized controlled trials and controlled clinical trials were identified by searching Pubmed, Embase and the Cochrane Central Register of Controlled Trials database until 15 July 2013. All included studies were critically appraised and analysed with the use of Review Manager 5.1.0 software according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement protocol. Twenty randomized and double-blinded studies published in 22 articles fulfilled the inclusion criteria for meta-analysis. The overall results demonstrated that the use of oral antidiabetic agents (analysed separately and together) was not associated with any significantly increased risk of any serious adverse events including hypoglycaemia and gastrointestinal disorders. Moreover, the use of DPP-4 or SGLT-2 inhibitors significantly decreased risk of diarrhoea compared with placebo, when given concomitantly with metformin. However, we found that the SGLT-2 inhibitors were more likely to cause a genital infection. Despite some limitations, the findings of this meta-analysis indicate that DPP-4 or SGLT-2 inhibitors have favourable safety profile, and such therapy, when combined with metformin is well tolerated.
本荟萃分析的目的是评估二肽基肽酶-4（DPP-4）抑制剂和钠-葡萄糖共转运蛋白 2（SGLT-2）抑制剂与安慰剂相比，作为二甲双胍治疗 2 型糖尿病患者的附加药物的安全性概况。通过搜索 Pubmed、Embase 和 Cochrane 对照试验中心注册数据库，直到 2013 年 7 月 15 日，确定了随机对照试验和对照临床试验。根据系统评价和荟萃分析报告的首选项目协议，使用 Review Manager 5.1.0 软件对所有纳入的研究进行了严格评估和分析。有 20 项随机和双盲研究发表在 22 篇文章中，符合荟萃分析的纳入标准。总体结果表明，使用口服降糖药物（分别和一起分析）与任何严重不良事件（包括低血糖和胃肠道疾病）的风险增加无关。此外，与安慰剂相比，当与二甲双胍同时使用时，DPP-4 或 SGLT-2 抑制剂可显著降低腹泻的风险。然而，我们发现 SGLT-2 抑制剂更有可能引起生殖器感染。尽管存在一些局限性，但这项荟萃分析的结果表明，DPP-4 或 SGLT-2 抑制剂具有良好的安全性概况，当与二甲双胍联合使用时，这种治疗方法耐受性良好。
