Abhijit Shete, Medical Department, Novartis Pharma AG, CH-4002 Basel, Switzerland.
World J Diabetes. 2013 Dec 15;4(6):358-64. doi: 10.4239/wjd.v4.i6.358.
To compare the use of vildagliptin and sulfonylurea with or without metformin in Indian Muslim patients with type 2 diabetes mellitus, fasting during Ramadan.
This was a 4-wk, multicenter, non-interventional, open-label, observational study. Incidence of hypoglycemic events (HEs), adverse events, and changes in glycosylated hemoglobin A1c (HbA1c), fasting plasma glucose, postprandial plasma glucose and body weight were measured pre- and post-Ramadan.
Totally, 97 patients were recruited and all completed the study (vildagliptin group, n = 55; sulfonylurea group, n = 42). HEs were reported in low frequencies in both the vildagliptin and the sulfonylurea groups [0 vs 2 (4.8%) patients, respectively]. Interestingly, HbA1c reduced by -0.43% (-4.71 mmol/mol) in the vildagliptin group [8.75% (72.10 mmol/mol) to 8.32% (67.38 mmol/mol), P = 0.009] while in the sulfonylurea group there was a small increase by 0.01% [0.08 mmol/mol; 8.64% (70.92 mmol/mol) to 8.65% (71.00 mmol/mol), P = 0.958]. Higher percentage of vildagliptin-treated patients achieved HbA1c < 7.0% (< 53 mmol/mol) compared with sulfonylurea (16.4% vs 4.8%). Mean decrease in the body weight was 1.2 kg and 0.03 kg, respectively (P < 0.001). Both treatment groups were well tolerated during Ramadan.
Vildagliptin is an attractive treatment option for Indian patients with type 2 diabetes mellitus who are fasting during Ramadan.
比较在斋月期间空腹的印度穆斯林 2 型糖尿病患者使用维格列汀和磺酰脲类药物（合用或不合用二甲双胍）的情况。
这是一项为期 4 周、多中心、非干预性、开放性、观察性研究。在斋月前后测量低血糖事件（HE）的发生率、不良事件以及糖化血红蛋白 A1c（HbA1c）、空腹血糖、餐后血糖和体重的变化。
共招募了 97 例患者，所有患者均完成了研究（维格列汀组，n = 55；磺酰脲组，n = 42）。维格列汀组和磺酰脲组的 HEs 发生率均较低[分别为 0 例（4.8%）和 2 例（4.8%）]。有趣的是，维格列汀组的 HbA1c 降低了-0.43%（-4.71mmol/mol）[8.75%（72.10mmol/mol）降至 8.32%（67.38mmol/mol），P = 0.009]，而磺酰脲组则略有升高 0.01%[0.08mmol/mol；8.64%（70.92mmol/mol）升至 8.65%（71.00mmol/mol），P = 0.958]。与磺酰脲类药物相比，更多的维格列汀治疗患者达到了 HbA1c<7.0%（<53mmol/mol）[16.4% vs 4.8%]。体重平均下降 1.2kg 和 0.03kg，差异有统计学意义（P<0.001）。两组患者在斋月期间均耐受良好。
维格列汀是一种有吸引力的治疗选择，可用于在斋月期间空腹的印度 2 型糖尿病患者。
