Efficacy and safety of acarbose in metformin-treated patients with type 2 diabetes
Efficacy and safety of acarbose in metformin-treated patients with type 2 diabetes
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DOI：
10.2337/diacare.21.12.2050
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发表时间：
1998-12-01
期刊：
影响因子：
16.2
通讯作者：
Magner, J
中科院分区：
文献类型：
--
作者：
Rosenstock, J;Brown, A;Magner, J
目的：比较阿卡波糖和安慰剂对饮食和二甲双胍(每天2,000或2,500 mg/天)控制不佳的2型糖尿病患者的疗效、耐受性和安全性。研究设计与方法：本研究采用多中心、随机、双盲、安慰剂对照、平行分组对照设计。试验持续31周，包括1周的筛查期、6周的安慰剂预备期和24周的阿卡波糖或安慰剂，强制滴定范围为25-50 mg/d。以及基于血糖控制的50-100 mg tid的滴定。主要疗效变量是HBA(1c)较基线的平均变化。次要疗效变量包括空腹和餐后血糖、血清胰岛素和甘油三酯水平与基线相比的平均变化。结果：在接受二甲双胍和饮食治疗的患者中，阿卡波糖的平均HBA(1c)下降了0.65%，具有统计学意义。与安慰剂相比，空腹和餐后血糖和血清胰岛素水平有统计学意义的降低。胃肠道副作用在接受阿卡波糖治疗的患者中更常见。服用阿卡波糖的患者和服用安慰剂的患者之间的肝脏转氨酶升高没有显著差异。结论--这项研究的结果表明，对于用二甲双胍和饮食控制不充分的2型糖尿病患者，服用阿卡波糖是安全的，总体上耐受性良好，它显著降低HBA(1c)以及空腹和餐后血糖和胰岛素水平。
OBJECTIVE - To demonstrate the efficacy, tolerability, and safety of acarbose compared with placebo in patients with type 2 diabetes inadequately controlled with diet and metformin (2,000 or 2,500 mg/day in divided doses).RESEARCH DESIGN AND METHODS - This study had a multicenter randomized double-blind placebo-controlled parallel-group comparison design. The trial lasted 31 weeks and consisted of a 1-week screening period, a 6-week placebo pretreatment period, and a 24-week period of acarbose or placebo, with a forced titration from 25-50 mg t,i.d. and a titration of 50-100 mg tid that was based on glucose control. The primary efficacy variable was the mean change from baseline in HbA(1c). Secondary efficacy variables included mean changes from baseline in fasting and postprandial plasma glucose, serum insulin, and triglyceride levels.RESULTS - The addition of acarbose to patients on background metformin and diet therapy showed a statistically significant reduction in mean HbA(1c) of 0.65%. There were statistically significant reductions in fasting and postprandial plasma glucose and serum insulin levels compared with placebo. Gastrointestinal side effects were more frequently reported in the acarbose-treated patients. No significant differences in liver transaminase elevations were observed between patients treated with acarbose and those treated with placebo.CONCLUSIONS - The results of this study demonstrate that the addition of acarbose to patients with type 2 diabetes who are inadequately controlled with metformin and diet is safe and generally well tolerated and that it significantly lowers HbA(1c) and fasting and postprandial glucose and insulin levels.