Chiasson Jean-Louis
Department of Medicine, Université de Montréal and Research Center, Centre Hospitalier de l'Université de Montréal, Quebec, Canada.
Endocr Pract. 2006 Jan-Feb;12 Suppl 1:25-30. doi: 10.4158/EP.12.S1.25.
To evaluate, in subjects with impaired glucose tolerance (IGT), the effect of acarbose on the incidence of diabetes, hypertension, and cardiovascular disease.
The Study to Prevent Non-Insulin-Dependent Diabetes Mellitus (STOP-NIDDM) Trial was an international, multicenter, double-blind, placebo-controlled, randomized investigation, undertaken in 9 participating countries from December 1995 through August 2001. Patients were randomly assigned to receive placebo (N = 715) or acarbose, 100 mg three times a day (N = 714), and underwent follow-up for a mean of 3.3 years. Sixty-one subjects (4%) were excluded from the study because they did not have IGT or had no postrandomization data; thus, 1,368 subjects remained for intent-to-treat analysis. The outcome measures were the development of diabetes based on a single oral glucose tolerance test, the development of hypertension ((3) 140/90 mm Hg), and the development of major cardiovascular events, including coronary heart disease, cardiovascular death, stroke, and peripheral vascular disease.
Two hundred eleven subjects in the acarbose-treated group and 130 in the placebo group discontinued treatment prematurely; however, they underwent follow-up for assessment of end points. Acarbose treatment resulted in a 25% relative risk reduction in the development of type 2 diabetes (hazards ratio [HR], 0.75; 95% confidence interval [CI], 0.63 to 0.90; P = 0.0015), in a 34% risk reduction in the development of new cases of hypertension (HR, 0.66; 95% CI, 0.49 to 0.89; P = 0.0059), and in a 49% risk reduction in the development of cardiovascular events (HR, 0.51; 95% CI, 0.28 to 0.95; P = 0.03). A post hoc cost-effectiveness analysis done from the Swedish perspective showed that acarbose treatment was likely to be cost-effective in the management of subjects with IGT.
The STOP-NIDDM Trial demonstrated that, in subjects with IGT, acarbose treatment was effective in reducing the risk of type 2 diabetes. It also suggested that it was associated with a reduction in hypertension and cardiovascular disease.
评估阿卡波糖对糖耐量受损（IGT）患者糖尿病、高血压及心血管疾病发病率的影响。
预防非胰岛素依赖型糖尿病研究（STOP-NIDDM）试验是一项国际性、多中心、双盲、安慰剂对照的随机研究，于1995年12月至2001年8月在9个参与国开展。患者被随机分配接受安慰剂（N = 715）或阿卡波糖（每日3次，每次100 mg，N = 714），平均随访3.3年。61名受试者（4%）因不具备IGT或无随机分组后的数据而被排除在研究之外；因此，1368名受试者纳入意向性分析。观察指标包括基于单次口服糖耐量试验的糖尿病发生情况、高血压（收缩压≥140/舒张压≥90 mmHg）的发生情况以及主要心血管事件的发生情况，包括冠心病、心血管死亡、中风和外周血管疾病。
阿卡波糖治疗组211名受试者和安慰剂组130名受试者提前终止治疗；然而，他们接受了终点评估随访。阿卡波糖治疗使2型糖尿病发生风险相对降低25%（风险比[HR]，0.75；95%置信区间[CI]，0.63至0.90；P = 0.0015），新发性高血压发生风险降低34%（HR，0.66；95% CI，0.49至0.89；P = 0.0059），心血管事件发生风险降低49%（HR，0.51；95% CI，0.28至0.95；P = 0.03）。从瑞典角度进行的事后成本效益分析表明，阿卡波糖治疗在IGT患者管理中可能具有成本效益。
STOP-NIDDM试验表明，在IGT患者中，阿卡波糖治疗可有效降低2型糖尿病风险。还提示其与高血压和心血管疾病风险降低相关。
