Efficacy and safety of sitagliptin monotherapy compared with voglibose in Japanese patients with type 2 diabetes: a randomized, double-blind trial
Efficacy and safety of sitagliptin monotherapy compared with voglibose in Japanese patients with type 2 diabetes: a randomized, double-blind trial
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DOI：
10.1111/j.1463-1326.2010.01197.x
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发表时间：
2010-07-01
影响因子：
5.8
通讯作者：
Amatruda, J. M.
中科院分区：
文献类型：
--
作者：
Iwamoto, Y.;Tajima, N.;Amatruda, J. M.
方法：在一项多中心、随机、双盲、平行组研究中，319 名患者被随机（1:1）接受为期 12 周的治疗，西格列汀 50 mg 每日一次，或伏格列波糖 0.2 mg 每日三次，饭前服用。主要分析评估了西格列汀在降低 HbA1c 方面是否不劣于伏格列波糖。结果：12 周后，西格列汀在降低 HbA1c 方面的功效不劣于伏格列波糖。此外，西格列汀优于伏格列波，使 HbA1c 较基线显着降低 [HbA1c 的最小二乘平均变化 [95% 置信区间 (CI)] 分别 = -0.7%（-0.8 至 -0.6）和 -0.3%（-0.4 至 -0.2）；组间差异 = -0.4%（-0.5 至 -0.3），p < 0.001]。西格列汀在其他关键疗效终点上也优于伏格列波糖，包括餐后 2 小时血糖相对于基线的变化（-2.8 mmol/l 与 -1.8 mmol/l，p < 0.001）和空腹血糖（-1.1 mmol/l 与 -0.5 mmol/l，p < 0.001）。 12周后，西他列汀组的临床不良事件（AE）、药物相关AE和胃肠道AE发生率（分别为48.5、10.4和18.4%）显着（p < 0.05）低于伏格列波组（分别为64.7、26.3和34.6%）。两组中低血糖、严重 AE 和因 AE 导致的停药的发生率均较低且相似。结论：在日本 2 型糖尿病患者中，每日一次西格列汀单药治疗比每日三次伏格列波在 12 周内显示出更高的疗效和更好的耐受性。
Methods: In a multi-center, randomized, double-blind, parallel-group study, 319 patients were randomized (1:1) to 12-week treatment with sitagliptin 50 mg once daily or voglibose 0.2 mg thrice daily before meals. The primary analysis assessed whether sitagliptin was non-inferior to voglibose in lowering HbA1c.Results: After 12 weeks, sitagliptin was non-inferior to voglibose for HbA1c-lowering efficacy. Furthermore, sitagliptin was superior to voglibose, providing significantly greater reductions in HbA1c from baseline [least squares mean changes in HbA1c [95% confidence intervals (CI)] = -0.7% (-0.8 to -0.6) and -0.3% (-0.4 to -0.2), respectively; between-group difference = -0.4% (-0.5 to -0.3), p < 0.001]. Sitagliptin was also superior to voglibose on other key efficacy endpoints, including change from baseline in 2-h postmeal glucose (-2.8 mmol/l vs. -1.8 mmol/l, p < 0.001) and fasting plasma glucose (-1.1 mmol/l vs. -0.5 mmol/l, p < 0.001). After 12 weeks, the incidences of clinical adverse experiences (AEs), drug-related AEs and gastrointestinal AEs in the sitagliptin group (48.5, 10.4 and 18.4%, respectively) were significantly (p < 0.05) lower than those in the voglibose group (64.7, 26.3 and 34.6%, respectively). The incidences of hypoglycaemia, serious AEs and discontinuations due to AEs were low and similar in both groups.Conclusions: In Japanese patients with type 2 diabetes, once-daily sitagliptin monotherapy showed greater efficacy and better tolerability than thrice-daily voglibose over 12 weeks.