Servicio de Endocrinología y Diabetes, Centro Médico Docente la Trinidad, Caracas, Venezuela.
Int J Clin Pract. 2011 Sep;65(9):930-8. doi: 10.1111/j.1742-1241.2011.02749.x.
The efficacy and safety of sitagliptin (SITA) monotherapy and SITA/metformin (MET) vs. pioglitazone (PIO) were assessed in patients with type 2 diabetes and moderate-to-severe hyperglycaemia (A1C = 7.5-12.0%).
In an initial 12-week phase (Phase A), 492 patients were randomised 1 : 1 in a double-blind fashion to SITA (100 mg qd) or PIO (15 mg qd, up-titrated to 30 mg after 6 weeks). In Phase B (28 additional weeks), the SITA group was switched to SITA/MET (up-titrated to 50/1000 mg bid over 4 weeks) and the PIO group was up-titrated to 45 mg qd
At the end of Phase A, mean changes from baseline were -1.0% and -0.9% for A1C; -26.6 mg/dl and -28.0 mg/dl for fasting plasma glucose; and -52.8 mg/dl and -50.1 mg/dl for 2-h post-meal glucose for SITA and PIO, respectively. At the end of Phase B, improvements in glycaemic parameters were greater with SITA/MET vs. PIO: -1.7% vs. -1.4% for A1C (p = 0.002); -45.8 mg/dl vs. -37.6 mg/dl for fasting plasma glucose (p = 0.03); -90.3 mg/dl vs. -69.1 mg/dl for 2-h postmeal glucose (p = 0.001); and 55.0% vs. 40.5% for patients with A1C < 7% (p = 0.004). A numerically higher incidence of gastrointestinal adverse events and a significantly lower incidence of oedema were observed with SITA/MET vs. PIO. The incidence of hypoglycaemia was similarly low in both groups. Body weight decreased with SITA/MET and increased with PIO (-1.1 kg vs. 3.4 kg; p < 0.001).
Improvements in glycaemic control were greater with SITA/MET vs. PIO, with weight loss vs. weight gain. Both treatments were generally well tolerated.
评估西他列汀（SITA）单药治疗以及 SITA/二甲双胍（MET）与吡格列酮（PIO）在 2 型糖尿病伴中重度高血糖（A1C=7.5-12.0%）患者中的疗效和安全性。
在初始的 12 周阶段（A 期），492 例患者以 1:1 的比例随机接受双盲治疗，分别接受 SITA（100mg 每日 1 次）或 PIO（15mg 每日 1 次，6 周后增至 30mg）。在 B 期（28 周追加治疗），SITA 组换用 SITA/MET（4 周内增至 50/1000mg 每日 2 次），PIO 组增至 45mg 每日 1 次。
A 期结束时，SITA 和 PIO 组的 A1C 自基线的平均变化分别为-1.0%和-0.9%；空腹血糖分别为-26.6mg/dl 和-28.0mg/dl；餐后 2 小时血糖分别为-52.8mg/dl 和-50.1mg/dl。B 期结束时，SITA/MET 组的血糖参数改善优于 PIO 组：A1C 分别为-1.7%和-1.4%（p=0.002）；空腹血糖分别为-45.8mg/dl 和-37.6mg/dl（p=0.03）；餐后 2 小时血糖分别为-90.3mg/dl 和-69.1mg/dl（p=0.001）；A1C＜7%的患者比例分别为 55.0%和 40.5%（p=0.004）。与 PIO 相比，SITA/MET 组胃肠道不良事件发生率更高，但水肿发生率显著更低。两组低血糖发生率均较低。SITA/MET 组体重下降，而 PIO 组体重增加（-1.1kg 和 3.4kg；p＜0.001）。
SITA/MET 组的血糖控制改善优于 PIO 组，体重减轻优于体重增加。两种治疗方案均具有良好的耐受性。
