Chiasson Jean-Louis, Josse Robert G, Gomis Ramon, Hanefeld Markolf, Karasik Avraham, Laakso Markku
Research Centre, Centre Hospitalier de l'Université de Montréal-Hôtel-Dieu and Department of Medicine, Université de Montréal, Montreal, Quebec, Canada.
JAMA. 2003 Jul 23;290(4):486-94. doi: 10.1001/jama.290.4.486.
The worldwide explosive increase in type 2 diabetes mellitus and its cardiovascular morbidity are becoming major health concerns.
To evaluate the effect of decreasing postprandial hyperglycemia with acarbose, an alpha-glucosidase inhibitor, on the risk of cardiovascular disease and hypertension in patients with impaired glucose tolerance (IGT).
DESIGN, SETTING, AND PARTICIPANTS: International, multicenter double-blind, placebo-controlled, randomized trial, undertaken in hospitals in Canada, Germany, Austria, Norway, Denmark, Sweden, Finland, Israel, and Spain from July 1998 through August 2001. A total of 1429 patients with IGT were randomized with 61 patients (4%) excluded because they did not have IGT or had no postrandomization data, leaving 1368 patients for a modified intent-to-treat analysis. Both men (49%) and women (51%) participated with a mean (SD) age of 54.5 (7.9) years and body mass index of 30.9 (4.2). These patients were followed up for a mean (SD) of 3.3 (1.2) years.
Patients with IGT were randomized to receive either placebo (n = 715) or 100 mg of acarbose 3 times a day (n = 714).
The development of major cardiovascular events (coronary heart disease, cardiovascular death, congestive heart failure, cerebrovascular event, and peripheral vascular disease) and hypertension (> or =140/90 mm Hg).
Three hundred forty-one patients (24%) discontinued their participation prematurely, 211 in the acarbose-treated group and 130 in the placebo group; these patients were also followed up for outcome parameters. Decreasing postprandial hyperglycemia with acarbose was associated with a 49% relative risk reduction in the development of cardiovascular events (hazard ratio [HR], 0.51; 95% confidence interval [CI]; 0.28-0.95; P =.03) and a 2.5% absolute risk reduction. Among cardiovascular events, the major reduction was in the risk of myocardial infarction (HR, 0.09; 95% CI, 0.01-0.72; P =.02). Acarbose was also associated with a 34% relative risk reduction in the incidence of new cases of hypertension (HR, 0.66; 95% CI, 0.49-0.89; P =.006) and a 5.3% absolute risk reduction. Even after adjusting for major risk factors, the reduction in the risk of cardiovascular events (HR, 0.47; 95% CI, 0.24-0.90; P =.02) and hypertension (HR, 0.62; 95% CI, 0.45-0.86; P =.004) associated with acarbose treatment was still statistically significant.
This study suggests that treating IGT patients with acarbose is associated with a significant reduction in the risk of cardiovascular disease and hypertension.
全球范围内2型糖尿病及其心血管疾病发病率呈爆发式增长，正成为主要的健康问题。
评估α-葡萄糖苷酶抑制剂阿卡波糖降低糖耐量受损（IGT）患者餐后高血糖对心血管疾病和高血压风险的影响。
设计、地点和参与者：1998年7月至2001年8月在加拿大、德国、奥地利、挪威、丹麦、瑞典、芬兰、以色列和西班牙的医院进行的一项国际多中心双盲、安慰剂对照随机试验。共有1429例IGT患者被随机分组，61例患者（4%）被排除，原因是他们没有IGT或没有随机分组后的数据，剩余1368例患者进行改良意向性分析。男性（49%）和女性（51%）均参与研究，平均（标准差）年龄为54.5（7.9）岁，体重指数为30.9（4.2）。这些患者平均（标准差）随访3.3（1.2）年。
IGT患者被随机分为接受安慰剂（n = 715）或每日3次服用100 mg阿卡波糖（n = 714）。
主要心血管事件（冠心病、心血管死亡、充血性心力衰竭、脑血管事件和外周血管疾病）的发生情况以及高血压（≥140/90 mmHg）。
341例患者（24%）提前退出研究，阿卡波糖治疗组211例，安慰剂组130例；这些患者也进行了结局参数随访。阿卡波糖降低餐后高血糖与心血管事件发生风险相对降低49%相关（风险比[HR]，0.51；95%置信区间[CI]：0.28 - 0.95；P = 0.03），绝对风险降低2.5%。在心血管事件中，主要降低的是心肌梗死风险（HR，0.09；95% CI，0.01 - 0.72；P = 0.02）。阿卡波糖还与新发性高血压发病率相对降低34%相关（HR，0.66；95% CI，0.49 - 0.89；P = 0.006），绝对风险降低5.3%。即使在对主要危险因素进行校正后，阿卡波糖治疗相关的心血管事件风险降低（HR，0.47；95% CI，0.24 - 0.90；P = 0.02）和高血压风险降低（HR，0.62；95% CI，0.45 - 0.86；P = 0.004）仍具有统计学意义。
本研究表明，用阿卡波糖治疗IGT患者可显著降低心血管疾病和高血压风险。
