Acarbose treatment and the risk of cardiovascular disease and hypertension in patients with impaired glucose tolerance - The STOP-NIDDM Ttrial
Acarbose treatment and the risk of cardiovascular disease and hypertension in patients with impaired glucose tolerance - The STOP-NIDDM Ttrial
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DOI：
10.1001/jama.290.4.486
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发表时间：
2003-07-23
影响因子：
120.7
通讯作者：
Laakso, M
中科院分区：
文献类型：
--
作者：
Chiasson, JL;Josse, RG;Laakso, M
背景 全球范围内 2 型糖尿病及其心血管发病率的爆炸式增长正在成为主要的健康问题。目的 评估阿卡波糖（一种 α-葡萄糖苷酶抑制剂）降低餐后高血糖对糖耐量受损 (IGT) 患者心血管疾病和高血压风险的影响。设计、设置和参与者 国际、多中心双盲、安慰剂对照、随机试验，在加拿大、德国、奥地利、挪威、丹麦的医院进行。从 1998 年 7 月到 2001 年 8 月，瑞典、芬兰、以色列和西班牙。共有 1429 名 IGT 患者被随机分组，其中 61 名患者 (4%) 被排除，因为他们没有 IGT 或没有随机化后数据，剩下 1368 名患者接受修改后的意向治疗分析。男性 (49%) 和女性 (51%) 均参与其中，平均 (SD) 年龄为 54.5 (7.9) 岁，体重指数为 30.9 (4.2)。这些患者的平均随访时间 (SD) 为 3.3 (1.2) 年。 干预 IGT 患者被随机分配接受安慰剂 (n=715) 或每天 3 次 100 mg 阿卡波糖 (n = 714)。 主要结果指标 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）和高血压（大于或等于结果 341 名患者 (24%) 提前终止参与，其中阿卡波糖治疗组 211 名，安慰剂组 130 名；还对这些患者的结果参数进行了随访。阿卡波糖降低餐后高血糖与心血管事件发生的相对风险降低 49% 相关（风险比 [HR]，0.51；95% 置信区间 [CI]；0.28-0.95；P=.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的风险（HR，0.09；95% CI，0.01-0.72；P=.02）。阿卡波糖还可以使新发高血压病例的相对风险降低 34%（HR，0.66；95% CI，0.49-0.89；P=.006），绝对风险降低 5.3%。即使在调整主要危险因素后，与阿卡波糖治疗相关的心血管事件（HR，0.47；95% CI，0.24-0.90；P=.02）和高血压（HR，0.62；95% CI，0.45-0.86；P=.004）风险的降低仍然具有统计学意义。 结论 这项研究表明，用阿卡波糖治疗 IGT 患者与风险的显着降低相关。心血管疾病和高血压。
Context The worldwide explosive increase in type 2 diabetes mellitus and its cardiovascular morbidity are becoming major health concerns.Objective 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.Intervention Patients with IGT were randomized to receive either placebo (n=715) or 100 mg of acarbose 3 times a day (n = 714).Main Outcome Measures The development of major cardiovascular events (coronary heart disease, cardiovascular death, congestive heart failure, cerebrovascular event, and peripheral vascular disease) and hypertension (greater than or equal to140/90 mm Hg).Results 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.Conclusion This study suggests that treating IGT patients with acarbose is associated with a significant reduction in the risk of cardiovascular disease and hypertension.