Endocrine Unit, Department of Medicine, Putrajaya Hospital, Putrajaya, Malaysia.
Endocrine Unit, Department of Medicine, Universiti Kebangsaan Malaysia Medical Centre, Kuala Lumpur, Malaysia.
Diabetes Obes Metab. 2016 Jun;18(6):628-32. doi: 10.1111/dom.12649. Epub 2016 Mar 22.
The aim of the present study was to assess the hypoglycaemia risk and safety of dapagliflozin compared with sulphonylurea during the fasting month of Ramadan. In this 12-week, randomized, open-label, two-arm parallel group study, 110 patients with type 2 diabetes who were receiving sulphonylurea and metformin were randomized either to receive 10 mg (n = 58) of dapagliflozin daily or to continue receiving sulphonylurea (n = 52). The primary outcome was to compare the effects of dapagliflozin and sulphonylurea on the proportions of patients with at least one episode of hypoglycaemia during Ramadan, as well as to assess the safety of dapagliflozin when used to treat patients observing Ramadan. A lower proportion of patients had reported or documented hypoglycaemia in the dapagliflozin group than in the sulphonylurea group: 4 (6.9%) versus 15 (28.8%); p = 0.002. The relative risk of any reported or documented hypoglycaemia in the 4th week of Ramadan was significantly lower in the dapagliflozin group: RR=0.24, 95%CI: 0.09, 0.68; p=0.002. No significance differences were observed between the two groups regarding postural hypotension (13.8 vs 3.8%; p = 0.210) or urinary tract infections (10.3 vs 3.8%; p = 0.277). In conclusion, fewer patients exhibited hypoglycaemia in the dapagliflozin group than in the sulphonylurea group.
本研究旨在评估达格列净与磺酰脲类药物在斋月期间的低血糖风险和安全性。在这项为期 12 周、随机、开放标签、双臂平行组研究中,110 例正在服用磺酰脲类药物和二甲双胍的 2 型糖尿病患者被随机分为每天接受 10mg 达格列净(n=58)或继续服用磺酰脲类药物(n=52)。主要结局是比较达格列净和磺酰脲类药物在斋月期间至少发生一次低血糖的患者比例,以及评估达格列净在治疗遵守斋月的患者时的安全性。接受达格列净治疗的患者中报告或记录的低血糖事件比例明显低于磺酰脲类药物组:4 例(6.9%)比 15 例(28.8%);p=0.002。在斋月的第 4 周,达格列净组任何报告或记录的低血糖事件的相对风险显著降低:RR=0.24,95%CI:0.09,0.68;p=0.002。两组患者在体位性低血压(13.8%比 3.8%;p=0.210)或尿路感染(10.3%比 3.8%;p=0.277)方面无显著差异。总之,达格列净组低血糖的患者少于磺酰脲类药物组。