Feng Miao, Lv Haihong, Xu Xia, Wang Jue, Lyu Wenyi, Fu Songbo
The First Hospital of Lanzhou University, Lanzhou, Gansu, P.R. China.
Columbia University in the City of New York, New York.
Medicine (Baltimore). 2019 Jul;98(30):e16575. doi: 10.1097/MD.0000000000016575.
Dapagliflozin, a novel inhibitor of sodium-glucose cotransporter-2 (SGLT-2), lowers blood glucose level by specifically inhibiting the activity of SGLT-2. Previous studies showed efficacy and safety of dapagliflozin combined with other antihyperglycemic agents in type 2 diabetes (T2DM), however, there are few studies for dapagliflozin as monotherapy. The aim of this study was to assess the efficacy and safety of dapagliflozin as a monotherapy in T2DM and provide theoretical basis for clinical rational use of drugs.
We did a systematic review and meta-analysis of randomized, placbo-controlled clinical studies in patients with type 2 diabetes. We searched PubMed, Embase, Cochrane Library, CNKI, Wanfang, and VIP database through October 2018, we also manually screened list of references to the previous meta-analysis of dapagliflozin in the treatment of type 2 diabetes. Data search and extraction were completed with a standardized data form and any discrepancies were resolved by consensus. A meta-analysis was conducted by using RevMan 5.3 software.
Six randomized controlled trials (RCTs) including 2033 patients were analyzed. Compared with placebo, dapagliflozin monotherapy was associated with a reduction in glycosylated hemoglobin A1c (HbA1c) (weighted mean difference [WMD]: -0.60%; 95% confidence interval [CI]: -0.67%, -0.52%; P < .00001), fasting plasam glucose (FPG) (WMD: -1.30 mmol/L; 95% CI: -1.52, -1.08; P < .00001), and body weight (WMD: -1.50 kg; 95% CI: -1.67, -1.32; P < .00001). Dapagliflozin was associated with an increased risk of urinary tract infections (relative risk [RR]: 1.74; 95% CI: 1.21, 2.49; P = .003) and genital tract infections (RR: 3.52; 95% CI: 2.06, 6.03; P < .00001).
Dapagliflozin monotherapy was well tolerated and effective in reducing the level of HbA1c, FPG, and body weight in patients with T2DM without increasing hypoglycaemia, although it may increase the risk of urinary tract infections and genital tract infections. This meta-analysis provides an evidence for the treatment in patients with T2DM. However, more randomized clinical evidences are still needed to verify the results.
达格列净是一种新型钠-葡萄糖协同转运蛋白2（SGLT-2）抑制剂，通过特异性抑制SGLT-2的活性来降低血糖水平。既往研究显示达格列净与其他降糖药物联合用于2型糖尿病（T2DM）时具有疗效和安全性，然而，关于达格列净单药治疗的研究较少。本研究旨在评估达格列净单药治疗T2DM的疗效和安全性，并为临床合理用药提供理论依据。
我们对2型糖尿病患者的随机、安慰剂对照临床研究进行了系统评价和荟萃分析。检索了截至2018年10月的PubMed、Embase、Cochrane图书馆、中国知网、万方和维普数据库，我们还手动筛选了先前关于达格列净治疗2型糖尿病的荟萃分析的参考文献列表。使用标准化数据表格完成数据检索和提取，任何差异通过协商解决。使用RevMan 5.3软件进行荟萃分析。
分析了6项随机对照试验（RCT），共2033例患者。与安慰剂相比，达格列净单药治疗可使糖化血红蛋白A1c（HbA1c）降低（加权均数差[WMD]：-0.60%；95%置信区间[CI]：-0.67%，-0.52%；P＜0.00001），空腹血糖（FPG）降低（WMD：-1.30 mmol/L；95%CI：-1.52，-1.08；P＜0.00001），体重降低（WMD：-1.50 kg；95%CI：-1.67，-1.32；P＜0.00001）。达格列净与尿路感染风险增加相关（相对危险度[RR]：1.74；95%CI：1.21，2.49；P = 0.003）和生殖道感染风险增加相关（RR：3.52；95%CI：2.06，6.03；P＜0.00001）。
达格列净单药治疗耐受性良好，可有效降低T2DM患者的HbA1c、FPG和体重水平，且不增加低血糖风险，尽管它可能增加尿路感染和生殖道感染的风险。本荟萃分析为T2DM患者的治疗提供了证据。然而，仍需要更多的随机临床证据来验证结果。
