Department of Pharmacy, the First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.
Department of Medical Administration, Chengdu Women's and Children's Central Hospital, Chengdu, China.
Diabetes Metab Res Rev. 2019 Oct;35(7):e3169. doi: 10.1002/dmrr.3169. Epub 2019 May 9.
Sodium-glucose cotransporter (SGLT) inhibitors added to insulin therapy have been proposed as treatment strategy for type 1 diabetes (T1D). We thus conducted a meta-analysis of randomized controlled trials (RCTs) to assess the efficacy and adverse effects of this combination in T1D. We searched the PubMed, EMBASE, and Cochrane Library databases and ClinicalTrials.gov for RCTs. Statistical analyses were performed using STATA 15. Ten eligible placebo-controlled trials involving 5961 patients were included. Compared with placebo, SGLT inhibitors were associated with a reduction in HbA1c of -0.39% (95% CI, -0.43 to -0.36), an improved mean amplitude of glucose excursion (MAGE) of -14.81 mg/dL (95% CI, -19.08 to -10.54), and a reduction in body weight of -3.47% (95% CI, -3.78 to -3.16), as well as no increased relative risk of hypoglycaemia (1.01; 95% CI, 0.99-1.02) or severe hypoglycaemia (0.91; 95% CI, 0.77-1.07). SGLT inhibitors decreased fasting plasma glucose and insulin requirement but increased the risk of genital infection (3.57; 95% CI, 2.97-4.29) and diabetic ketoacidosis (3.11; 95% CI, 2.11-4.58). However, the very low dose empagliflozin (2.5 mg) did not increase the risk of diabetic ketoacidosis (risk ratio [RR] 0.67; 95% CI, 0.11-3.95). SGLT inhibitors had no effect on overall adverse events, urinary tract infection, or bone fracture but slightly increased the risk of serious adverse events (1.35; 95% CI, 1.16-1.58), severe adverse events (1.84; 95% CI, 1.20-2.84), adverse events leading to discontinuation (1.50; 95% CI, 1.22-1.84), drug-related adverse events (1.78; 95% CI, 1.44-2.19), and diarrhoea (1.54; 95% CI, 1.15-2.05). Although adverse events exist, the available data provide evidence that the combination of SGLT inhibitors with basal insulin treatment is beneficial in patients with T1D.
钠-葡萄糖共转运蛋白 (SGLT) 抑制剂联合胰岛素治疗被提议作为 1 型糖尿病 (T1D) 的治疗策略。因此，我们进行了一项荟萃分析，以评估这种联合治疗在 T1D 中的疗效和不良反应。我们检索了 PubMed、EMBASE 和 Cochrane 图书馆数据库以及 ClinicalTrials.gov 中的随机对照试验 (RCT)。使用 STATA 15 进行统计分析。纳入了 10 项安慰剂对照试验，涉及 5961 名患者。与安慰剂相比，SGLT 抑制剂可使 HbA1c 降低 -0.39%（95%CI，-0.43 至 -0.36），平均血糖波动幅度 (MAGE) 降低 -14.81mg/dL（95%CI，-19.08 至 -10.54），体重减轻 -3.47%（95%CI，-3.78 至 -3.16），低血糖的相对风险无增加（1.01；95%CI，0.99-1.02）或严重低血糖（0.91；95%CI，0.77-1.07）。SGLT 抑制剂降低空腹血糖和胰岛素需求，但增加生殖器感染（3.57；95%CI，2.97-4.29）和糖尿病酮症酸中毒（3.11；95%CI，2.11-4.58）的风险。然而，非常低剂量的恩格列净（2.5mg）并未增加糖尿病酮症酸中毒的风险（风险比 [RR] 0.67；95%CI，0.11-3.95）。SGLT 抑制剂对总体不良事件、尿路感染或骨折没有影响，但略微增加严重不良事件（1.35；95%CI，1.16-1.58）、严重不良事件（1.84；95%CI，1.20-2.84）、导致停药的不良事件（1.50；95%CI，1.22-1.84）、药物相关不良事件（1.78；95%CI，1.44-2.19）和腹泻（1.54；95%CI，1.15-2.05）的风险。尽管存在不良反应，但现有数据提供的证据表明，SGLT 抑制剂与基础胰岛素联合治疗对 T1D 患者有益。
