Department of Internal Medicine, New York University Medical Center, New York, USA.
Department of Family Medicine, Rafik Hariri Directorate of Health & Social Services, Beirut, Lebanon.
Ther Adv Endocrinol Metab. 2014 Feb;5(1):3-9. doi: 10.1177/2042018814529062.
To study the incidence of hypoglycemia, glycemic control and body weight changes in patients with type 2 diabetes treated with vildagliptin and metformin versus another group treated with sulphonylureas and metformin during and after the period of fasting in Ramadan.
This is a randomized open-label clinical trial that recruited 69 patients previously treated with a combination therapy of metformin and sulphonylurea. Patients in the control group were maintained on their usual metformin and sulphonylurea regimen with dose adjustment for the fasting period. Patients in the study group were given vildagliptin 50 mg twice daily (at Suhur and at Iftar). One group remained on the previous background therapy unchanged and the other group was switched from sulphonylurea to vildagliptin in combination with metformin. Four visits were scheduled, one before the beginning of Ramadan (baseline), a second visit at mid Ramadan, a third at the end of Ramadan and a final visit 1 month after the end of Ramadan. At every visit, patients were assessed for hypoglycemic events and patient education was given on lifestyle needs and hypoglycemia monitoring and management.
The calculated change in hemoglobin A1c from baseline to last visit was similar for both groups. The incidence of hypoglycemia during Ramadan was higher in the control group (26 episodes versus 19 episodes in the study group); this result was not statistically significant (p = 0.334). However, the number of patients who dropped out from the study because of discomfort due to treatment and fear of hypoglycemia was higher in the control group.
For patients who insist on observing the fast, physicians can allow it only with close follow up and monitoring for hypoglycemic events, and vildagliptin may be a better agent than sulphonylurea.
研究在斋月禁食期间和之后，接受维格列汀和二甲双胍治疗的 2 型糖尿病患者与接受磺脲类药物和二甲双胍治疗的另一组患者的低血糖发生率、血糖控制和体重变化。
这是一项随机开放标签临床试验，招募了 69 名先前接受二甲双胍和磺脲类药物联合治疗的患者。对照组患者继续接受常规的二甲双胍和磺脲类药物治疗，并根据禁食期调整剂量。研究组患者给予维格列汀 50mg，每日两次（在 Suhur 和 Iftar 时服用）。一组患者继续使用以前的基础治疗方案不变，另一组患者从磺脲类药物改为维格列汀联合二甲双胍。共安排了 4 次就诊，一次在斋月开始前（基线），第二次在斋月中期，第三次在斋月结束时，第四次在斋月结束后 1 个月。每次就诊时，评估患者低血糖事件，并对生活方式需求、低血糖监测和管理进行患者教育。
从基线到最后一次就诊，两组患者的血红蛋白 A1c 变化计算值相似。对照组在斋月期间发生低血糖的发生率较高（26 例与研究组的 19 例相比）；但这一结果无统计学意义（p = 0.334）。然而，由于治疗不适和对低血糖的恐惧而退出研究的患者，对照组较多。
对于坚持禁食的患者，医生只能在密切随访和监测低血糖事件的情况下允许他们禁食，维格列汀可能是比磺脲类药物更好的药物。
