Chan J C, Chan K W, Ho L L, Fuh M M, Horn L C, Sheaves R, Panelo A A, Kim D K, Embong M
Department of Clinical Pharmacology, Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, China.
Diabetes Care. 1998 Jul;21(7):1058-61. doi: 10.2337/diacare.21.7.1058.
To assess the efficacy, safety, and tolerability of acarbose versus placebo during a 24-week treatment period in Asian type 2 diabetic patients with dietary failure.
After a 6-week screening period, 126 multiethnic Asian type 2 diabetic patients (64 men, 62 women; mean age +/- SD, 53.4 +/- 10 years) were randomized to receive acarbose (n = 63) or placebo (n = 63). The dosage was increased from 50 mg t.i.d. at week 0 to 100 mg t.i.d. at week 4. Patients were then followed up at weeks 10, 16, and 24. At each visit, body weight, blood pressure, and metabolic indexes were measured. At weeks 0 and 24, fasting plasma glucose and insulin were measured before and 1 h after the administration of an individually tailored breakfast.
Using the intention-to-treat analysis, there were greater reductions in (mean [95% CI]) HbA1c (-0.70 [-1.00 to -0.39] vs. -0.27% [-0.54 to 0]; P = 0.04), fasting plasma glucose (-0.37 [-0.75 to 0.02] vs. 0.41 mmol/l [-0.08 to 0.90]; P = 0.017) and 1-h plasma glucose (-0.77 [-1.44 to -0.10] vs. 0.65 mmol/l [-0.07 to 1.36]; P = 0.05) in the acarbose group compared with the placebo group. With acarbose treatment, 78% of patients achieved an HbAlc < 8% compared with 56% in the placebo group (P = 0.003). There was a greater reduction in body weight (-1.31 [-2.46 to -0.15] vs. 0.16 kg [-3.36 to 0.10]; P = 0.02) and higher incidence of flatulence (56 vs. 37%; P = 0.032) in the acarbose than in the placebo group. Using baseline HbA1c and race as covariates, there were no significant interethnic differences in treatment responses (P = 0.232 for treatment-race interaction; P < 0.001 for treatment effect). The dropout rates were similar between the two groups (acarbose, 11 of 63; placebo, 6 of 63). There were no significant laboratory adverse events in either group.
In this multicenter study involving six ethnic groups, acarbose 100 mg t.i.d. was an effective, safe, and generally well-tolerated therapy in Asian type 2 diabetic patients with dietary failure. In some patients with troublesome gastrointestinal symptoms, a lower dosage may be necessary.
评估在24周治疗期内，阿卡波糖对比安慰剂对饮食控制不佳的亚洲2型糖尿病患者的疗效、安全性和耐受性。
经过6周的筛查期后，126例多民族亚洲2型糖尿病患者（64例男性，62例女性；平均年龄±标准差，53.4±10岁）被随机分为接受阿卡波糖组（n = 63）或安慰剂组（n = 63）。剂量从第0周的50 mg每日三次增加到第4周的100 mg每日三次。然后在第10、16和24周对患者进行随访。每次访视时，测量体重、血压和代谢指标。在第0周和第24周，在给予个体化定制早餐前和早餐后1小时测量空腹血糖和胰岛素。
采用意向性分析，阿卡波糖组在糖化血红蛋白（平均[95%CI]）（-0.70[-1.00至-0.39] vs. -0.27%[-0.54至0]；P = 0.04）、空腹血糖（-0.37[-0.75至0.02] vs. 0.41 mmol/l[-0.08至0.90]；P = 0.017）和餐后1小时血糖（-0.77[-1.44至-0.10] vs. 0.65 mmol/l[-0.07至1.36]；P = 0.05）方面的降低幅度均大于安慰剂组。接受阿卡波糖治疗的患者中，78%的患者糖化血红蛋白<8%，而安慰剂组为56%（P = 0.003）。阿卡波糖组的体重下降幅度更大（-1.31[-2.46至-0.15] vs. 0.16 kg[-3.36至0.10]；P = 0.02），胀气发生率更高（56% vs. 37%；P = 0.032）。以基线糖化血红蛋白和种族作为协变量，各民族间治疗反应无显著差异（治疗-种族交互作用P = 0.232；治疗效果P<0.001）。两组的脱落率相似（阿卡波糖组，63例中有11例；安慰剂组，63例中有6例）。两组均无显著的实验室不良事件。
在这项涉及六个民族的多中心研究中，每日三次服用100 mg阿卡波糖对饮食控制不佳的亚洲2型糖尿病患者是一种有效、安全且总体耐受性良好的治疗方法。对于一些有胃肠道症状困扰的患者，可能需要较低的剂量。
