Diacon Hospital, Bangalore, India.
Curr Med Res Opin. 2012 Aug;28(8):1289-96. doi: 10.1185/03007995.2012.707119. Epub 2012 Jul 6.
To compare the incidence of symptomatic hypoglycemia between sitagliptin and sulfonylurea in Muslim patients with type 2 diabetes who fasted during Ramadan.
In a multicenter, pragmatic, randomized study, patients with type 2 diabetes were recruited from clinical centers in India (n = 765) and Malaysia (n = 105). Eligible patients (age ≥ 18 yrs) expressed their intention to daytime fast during Ramadan, were treated with a stable dose of sulfonylurea with or without metformin for ≥3 months prior to screening visit, and had an HbA(1c) ≤ 10%. Patients were randomized in a 1:1 ratio to either switch to sitagliptin 100 mg q.d. or remain on their pre-study sulfonylurea. Daily diary cards were completed to document information on hypoglycemic symptoms and complications. The primary endpoint was the overall incidence of symptomatic hypoglycemia during Ramadan.
Of the 870 patients randomized, 848 (n = 421 for sitagliptin and 427 for sulfonylurea) returned ≥1 completed diary card and were included in the analysis. The proportion of patients who recorded ≥1 symptomatic hypoglycemic event during Ramadan was lower with sitagliptin (3.8%) compared to sulfonylurea (7.3%). The risk of symptomatic hypoglycemia was significantly lower with sitagliptin (risk ratio [95% CI] = 0.52 [0.29, 0.94]; p = 0.028). By country, the proportions of patients who recorded ≥1 symptomatic hypoglycemic event during Ramadan were 4.1% vs. 7.7% in India and 1.9% vs. 3.8% in Malaysia for sitagliptin and sulfonylurea, respectively. No patient discontinued treatment due to a hypoglycemic event. One patient on sitagliptin and seven on sulfonylurea had an event that required non-medical assistance. No events required medical assistance. Both treatments were generally well tolerated.
Symptomatic hypoglycemic events did not require a confirmatory blood glucose measurement, which may have overestimated hypoglycemic events. Measures of glycemic control and body weight were not assessed.
Switching antihyperglycemic treatment to sitagliptin from a sulfonylurea reduced the risk of symptomatic hypoglycemia by approximately 50% for Muslim patients with type 2 diabetes who fasted during Ramadan.
Clinicaltrials.gov: NCT01340768.
比较在斋月期间禁食的 2 型糖尿病穆斯林患者中，西他列汀与磺酰脲类药物发生症状性低血糖的发生率。
在这项多中心、实用、随机研究中，从印度（n=765）和马来西亚（n=105）的临床中心招募 2 型糖尿病患者。符合条件的患者（年龄≥18 岁）表示在斋月期间有白天禁食的意愿，在筛选就诊前至少已接受磺酰脲类药物联合或不联合二甲双胍稳定剂量治疗≥3 个月，且糖化血红蛋白（HbA1c）≤10%。患者以 1:1 的比例随机分配至改用西他列汀 100mg 每日 1 次或继续使用研究前的磺酰脲类药物。每日填写日记卡以记录低血糖症状和并发症的信息。主要终点是斋月期间症状性低血糖的总体发生率。
在 870 例随机患者中，848 例（西他列汀组 n=421 例，磺酰脲类组 n=427 例）至少返回 1 份完成的日记卡并纳入分析。记录有≥1 次症状性低血糖事件的患者比例，西他列汀组（3.8%）低于磺酰脲类组（7.3%）。西他列汀的症状性低血糖风险显著降低（风险比[95%CI]为 0.52[0.29，0.94]；p=0.028）。按国家划分，在印度，记录有≥1 次症状性低血糖事件的患者比例，西他列汀组和磺酰脲类组分别为 4.1%和 7.7%；在马来西亚，西他列汀组和磺酰脲类组分别为 1.9%和 3.8%。没有患者因低血糖事件而停止治疗。西他列汀组有 1 例患者和磺酰脲类组有 7 例患者的事件需要非医疗援助。没有事件需要医疗援助。两种治疗方法通常都耐受良好。
症状性低血糖事件未要求进行确证性血糖测量，这可能高估了低血糖事件。未评估血糖控制和体重的测量指标。
在斋月期间禁食的 2 型糖尿病穆斯林患者中，将抗高血糖治疗由磺酰脲类药物转换为西他列汀可使症状性低血糖的风险降低约 50%。
Clinicaltrials.gov：NCT01340768。
