Design of the cooperative study on glycemic control and complications in diabetes mellitus type 2 Veterans Affairs Diabetes Trial
Design of the cooperative study on glycemic control and complications in diabetes mellitus type 2 Veterans Affairs Diabetes Trial
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DOI：
10.1016/s1056-8727(02)00277-5
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发表时间：
2003-11-01
影响因子：
3
通讯作者：
Henderson, W
中科院分区：
文献类型：
--
作者：
Abraira, C;Duckworth, W;Henderson, W
简介：2型糖尿病的长期血糖控制试验显示，视网膜光凝的主要临床获益差异（英国前瞻性糖尿病研究[UKPDS]中3/1000），但对视力或肾衰竭无影响。尚无强化血糖控制试验影响心血管（CV）事件，这是发病率和死亡率的主要原因。相比之下，适度降低血压对视力、肾功能、CV事件和死亡率具有保护作用。对于患有晚期并发症的老年、肥胖患者（退伍军人事务部（VA）系统中最常见的患者），尚未确定最佳血糖控制目标。此类患者的早期可行性试验（VA-CSDM）表明，随着血红蛋白A1 c（HbA1c）水平降低，CV结局可能会更差。目的：退伍军人事务部糖尿病试验（VADT）的主要目的是评估强化血糖治疗对CV事件的影响。其他目标是对微血管病、生活质量和成本效益的影响。研究设计和方法：VADT于2000年12月开始，在20个VA医疗中心招募了1700名先前未控制胰岛素或最大剂量口服药物的男性和女性。累积2年，随访5 - 7年，每1.5个月访视一次。该研究检测重大CV事件（CV死亡、心肌梗死[MI]、脑血管意外[CVA]、充血性心力衰竭[CHF]、血运重建和缺血性截肢）相对减少21%的把握度为86%。受试者被随机分配至旨在达到正常HbA1c水平的强化治疗组或常规血糖控制改善的标准治疗组。将保持HbA1c分离> 1.5%（预期2%）。两组均接受阶梯治疗：格列美脲或二甲双胍加罗格列酮，并添加胰岛素或其他口服药物以达到目标。严格控制血压和血脂异常，每日服用阿司匹林，饮食和教育在两组中相同。全程测量血浆纤维蛋白原、纤溶酶原激活抑制剂I（PAI-1）、血脂、肾功能参数和ECG。在入组时和5岁时获得立体视网膜照片，每年进行眼科检查，并根据需要进行干预以防止视力下降。招募正在按计划进行：入组时的当前平均HbA1c为9.4 +/-1.6%，诊断糖尿病的平均持续时间为11 +/-8年。(C)2003年爱思唯尔公司All rights reserved.
Introduction: Long-term glycemic control trials in type 2 diabetes show as the main clinical benefit a difference in retinal photocoagulation (3/1000 in the UK Prospective Diabetes Study [UKPDS]), but no effect on visual acuity or renal failure. No intensive glycemic control trial has yet affected cardiovascular (CV) events, the main cause of morbidity and mortality. By contrast, modest blood pressure reduction has protective effects on visual acuity, renal function, CV events, and mortality. Optimal glycemic control goals are not established in elderly, obese persons with advanced complications, the most common patients in the Veterans Affairs (VA) system. The earlier feasibility trial in such patients (VA-CSDM) suggested potentially worse CV outcomes with lower attained hemoglobin A1c (HbA1c) levels. Objectives: The primary objective of the Veterans Affairs Diabetes Trial (VADT) is the assessment of the effect of intensive glycemic treatment on CV events. Other objectives are effects on microangiopathy, quality of life, and cost effectiveness. Research Design and Methods: The VADT, started in December 2000, is enrolling 1700 men and women previously uncontrolled on insulin or maximum doses of oral agents at 20 VA medical centers. Accrual is 2 years and follow-up is 5 - 7 years, with visits every 1.5 months. The study has a power of 86% to detect a 21% relative reduction in major CV events (CV death, myocardial infarction [MI], cerebrovascular accident [CVA], congestive heart failure [CHF], revascularization and amputation for ischemia). Subjects are randomized to an intensive arm aiming at normal HbA1c levels or to a standard arm with usual, improved glycemic control. An HbA1c separation of > 1.5% is to be maintained (expected 2%). Both arms receive step therapy: glimepiride or metformin plus rosiglitazone and addition of insulin or other oral agents to achieve goals. Strict control of blood pressure and dyslipidemia, daily aspirin, diet, and education are identical in both arms. Plasma fibrinogen, plasminogen-activating inhibitor I (PAI-I), lipids, renal function parameters, and ECG are measured throughout. Stereo retinal photographs are obtained at entry and 5 years, eye examinations yearly, and intervention as needed to prevent visual deterioration. Recruitment is proceeding on schedule: the current mean HbA1c at entry is 9.4 +/- 1.6% and mean duration of diagnosed diabetes 11 +/- 8 years. (C) 2003 Elsevier Inc. All rights reserved.