Gradenigo Hospital, Turin, Italy.
Ann Med. 2012 Jun;44(4):375-93. doi: 10.3109/07853890.2011.560181. Epub 2011 Apr 15.
Current treatment of hyperglycemia in type 2 diabetes (T2DM) is often ineffective and has unwanted effects. Therefore, novel antidiabetic drugs are under development.
To assess efficacy and safety of the new antidiabetic drugs sodium glucose co-transport-2 (SGLT2) inhibitors in T2DM. Design and setting. Among 151 articles published on MEDLINE, Cochrane Library, EMBASE, PubMed, International meeting abstracts through December 2010, 13 randomized placebo-controlled trials (RCT) were included.
Two reviewers retrieved articles and evaluated study quality by appropriate scores. Main outcomes were pooled using random- or fixed-effects models.
Dapagliflozin significantly reduced HbA1c (weighted mean difference (WMD) -0.52%; 95% CI -0.46, -0.57%; P < 0.00001) fasting plasma glucose (WMD -18.28 mg/dL; 95% CI -20.66, -15.89; P < 0.00001), body mass index (WMD -1.17%; -1.41, -0.92%; P < 0.00001), systolic (WMD -4.08 mmHg; -4.91, -3.24), and diastolic (WMD -1.16 mmHg; -1.67, -0.66) blood pressure, and serum uric acid (WMD -41.50 μmol/L; -47.22, -35.79). Other SGLT2 inhibitors showed similar results. Dapagliflozin treatment increased the risk of urinary (OR 1.34; 1.05-1.71) and genital (OR 3.57; 2.59-4.93) tract infection; it also mildly increased the risk of hypoglycemia (OR 1.27; 1.05-1.53) when co-administered with insulin.
Limitations of the literature include the small number, size, and duration of RCTs.
Pending confirmation from larger RCTs, this analysis shows SGLT2 inhibitors are safe and effective for hyperglycemia treatment in T2DM.
目前,2 型糖尿病(T2DM)高血糖的治疗往往效果不佳且有不良反应。因此,新型抗糖尿病药物正在研发中。
评估新型抗糖尿病药物钠-葡萄糖共转运蛋白 2(SGLT2)抑制剂在 T2DM 中的疗效和安全性。设计和设置:检索 2010 年 12 月前 MEDLINE、Cochrane 图书馆、EMBASE、PubMed 及国际会议摘要中发表的 151 篇文章,纳入 13 项随机安慰剂对照试验(RCT)。
由 2 位评审员检索文章,并通过适当的评分评估研究质量。使用随机或固定效应模型汇总主要结局。
达格列净显著降低糖化血红蛋白(加权均数差值 WMD -0.52%;95%CI -0.46,-0.57%;P < 0.00001)、空腹血糖(WMD -18.28mg/dL;95%CI -20.66,-15.89;P < 0.00001)、体重指数(WMD -1.17%;-1.41,-0.92%;P < 0.00001)、收缩压(WMD -4.08mmHg;-4.91,-3.24)和舒张压(WMD -1.16mmHg;-1.67,-0.66),以及血清尿酸(WMD -41.50μmol/L;-47.22,-35.79)。其他 SGLT2 抑制剂也有类似的结果。达格列净治疗增加了泌尿(OR 1.34;1.05-1.71)和生殖(OR 3.57;2.59-4.93)系统感染的风险,还轻度增加了与胰岛素合用的低血糖(OR 1.27;1.05-1.53)的风险。
文献的局限性包括 RCT 数量少、规模小且持续时间短。
在更大规模 RCT 确认之前,本分析显示 SGLT2 抑制剂在 T2DM 高血糖治疗中安全有效。