Diabetes and metabolism - Baseline characteristics of patients with diabetes and coronary artery disease enrolled in the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) trial - The BARI 2D study group
Diabetes and metabolism - Baseline characteristics of patients with diabetes and coronary artery disease enrolled in the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) trial - The BARI 2D study group
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DOI：
10.1016/j.ajh.2008.05.015
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发表时间：
2008-09-01
影响因子：
4.8
通讯作者：
Tardif, Jean-Claude
中科院分区：
文献类型：
--
作者：
Brooks, Maria Mori;Barsness, Gregory;Tardif, Jean-Claude
背景2型糖尿病旁路血管成形术血运重建研究（巴里2D）进行了一项试验，以确定在存在积极药物治疗的情况下，早期血运重建干预是否上级延迟干预，以及在减少2型糖尿病和稳定性冠状动脉疾病患者的心血管事件方面，靶向胰岛素敏感性的抗糖尿病方案是否比靶向胰岛素供应的方案更有效或更无效。方法巴里2D试验是美国国立卫生研究院赞助的随机临床试验，采用2 × 2析因设计。2001年至2005年，北美、南美和欧洲的49个临床研究中心随机分配了2,368名患者。在基线时，试验收集了临床病史、症状和药物沿着的数据，并对血管造影、心电图和血液和尿液标本进行了集中评价。结果大多数巴里2D患者是从心导管实验室（54%）或心脏病诊所（27%）转诊的。在随机参与者中，30%是女性，34%是少数民族，61%有心绞痛，多部位CAD占67%。此外，29%的患者接受过胰岛素治疗，58%的患者血红蛋白A（1c）> 7.0%，41%的患者低密度脂蛋白2胆固醇>= 100 mg/dL，52%的患者血压> 130/80 mm Hg，56%的患者体重指数>= 30 kg/m2。并且研究组群的临床特征代表了目标人群。因此，巴里2D临床试验在评估糖尿病和CAD的替代治疗方法方面处于非常有利的地位。
Background The Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) trial was undertaken to determine whether early revascularization intervention is superior to deferred intervention in the presence of aggressive medical therapy and whether antidiabetes regimens targeting insulin sensitivity are more or less effective than regimens targeting insulin provision in reducing cardiovascular events among patients with type 2 diabetes mellitus and stable coronary artery disease (CAD).Methods The BARI 2D trial is a National Institutes of Health-sponsored randomized clinical trial with a 2 x 2 factorial design. Between 2001 and 2005, 49 clinical sites in North America, South America, and Europe randomized 2,368 patients. At baseline, the trial collected data on clinical history, symptoms, and medications along with centralized evaluations of angiograms, electrocardiograms, and blood and urine specimens.Results Most of the BARI 2D patients were referred from the cardiac catheterization laboratory (54%) or cardiology clinic (27%) Of the randomized participants, 30% were women, 34% were minorities, 61 % had angina, and 67% had multiregion CAD. Moreover, 29% had been treated with insulin, 58% had hemoglobin A(1c) > 7.0%, 41% had low-density lipoprotein 2 cholesterol >= 100 mg/dL, 52% had blood pressure > 130/80 mm Hg, and 56% had body mass index >= 30 kg/m(2).Conclusions Baseline characteristics in BARI 2D are well balanced between the randomized treatment groups, and the clinical profile of the study cohort is representative of the target population. As a result, the BARI 2D clinical trial is in an excellent position to evaluate alternative treatment approaches for diabetes and CAD.