Costa B, Piñol C
Grup per a l'Estudi de la Diabetis, Catalan Institute of Health (Primary Health Care Division, Reus-Altebrat), Tarragona, Catalonia, Spain.
Diabetes Res Clin Pract. 1997 Oct;38(1):33-40. doi: 10.1016/s0168-8227(97)00083-1.
To assess the efficacy and safety of acarbose as an adjunct to high sulfonylurea (SU) doses in patients with imminent SU failure, a randomised, multicentric, 6 month double-blind, parallel and placebo-controlled trial was performed in primary healthcare. Entry criteria were: NIDDM patients in concomitant dietary follow-up, age > 40 year-old, more than 3 years of diagnosed diabetes, baseline HbAlc levels between 8-12% (N: 4-6%), stable body mass index < 35 kg m-2 and glibenclamide daily dose > 10 mg. After 1 month placebo run-in period all patients were randomly allocated into two groups of treatment (acarbose 100 mg t.i.d. vs placebo). HbAlc levels, the main efficacy variable, lipid profile, fasting and postprandial blood glucose levels were performed and adverse events were also recorded. A total number of 65 patients were randomised, 36 in acarbose and 29 in a placebo group. No statistical differences were found on age (60.2/61.7 year-old), BMI (28.7/27.4 kg m-2), glibenclamide dose (14.5/14.0 mg/day) and baseline HbAlc (9.0/8.8%). Acarbose-treated patients significantly reduced HbAlc levels (9.0/7.9 vs 8.8/8.5%; P < 0.01), based upon a marked decrease, but statistically not significant, in mean postprandial plasma glucose levels (11.9/9.6 vs 12.4/11.1 mmol l-1). No significant differences between fasting plasma glucose and lipid profile were detected. A total of 31 patients (47.7%) reported adverse events, 20 (55.5%) and 11 (37.9%) in acarbose and placebo treatment group respectively. Relationship with drug was estimated as possible or probable in 16 (44.4%) of acarbose-treated patients. None of them were excluded from study participation due to insulin requirement. Only seven patients (10.7%), six with acarbose (16.6%) and one with placebo (3.8%), withdrew the study because of the adverse events. Thus, acarbose seems to be a useful option in order to improve HbAlc levels in non-insulin-dependent diabetes mellitus with imminent sulfonylurea failure.
为评估阿卡波糖作为高剂量磺脲类药物（SU）辅助用药对即将出现SU失效患者的疗效和安全性，在基层医疗保健机构开展了一项随机、多中心、为期6个月的双盲、平行、安慰剂对照试验。入选标准为：接受饮食随访的2型糖尿病患者，年龄>40岁，确诊糖尿病超过3年，基线糖化血红蛋白（HbAlc）水平在8%-12%（国际单位：4%-6%）之间，稳定体重指数<35kg/m²，格列本脲日剂量>10mg。经过1个月的安慰剂导入期后，所有患者被随机分为两组进行治疗（阿卡波糖100mg每日三次与安慰剂）。检测了主要疗效变量HbAlc水平、血脂谱、空腹和餐后血糖水平，并记录了不良事件。共有65例患者被随机分组，36例接受阿卡波糖治疗，29例接受安慰剂治疗。在年龄（60.2/61.7岁）、体重指数（28.7/27.4kg/m²）、格列本脲剂量（14.5/14.0mg/天）和基线HbAlc（9.0/8.8%）方面未发现统计学差异。基于餐后平均血糖水平显著下降但无统计学意义（11.9/9.6 vs 12.4/11.1mmol/L），阿卡波糖治疗组患者的HbAlc水平显著降低（9.0/7.9 vs 8.8/8.5%；P<0.01）。在空腹血糖和血脂谱方面未检测到显著差异。共有31例患者（47.7%）报告了不良事件，阿卡波糖治疗组和安慰剂治疗组分别为20例（55.5%）和11例（37.9%）。在阿卡波糖治疗的患者中，16例（44.4%）的不良事件与药物的关系被评估为可能或很可能。由于需要胰岛素治疗，他们中没有人被排除在研究之外。只有7例患者（10.7%）因不良事件退出研究，其中6例使用阿卡波糖（16.6%），1例使用安慰剂（3.8%）。因此，对于即将出现磺脲类药物失效的非胰岛素依赖型糖尿病患者，阿卡波糖似乎是改善HbAlc水平的一个有用选择。
