Action to control cardiovascular risk in diabetes (ACCORD) trial: Design and methods
Action to control cardiovascular risk in diabetes (ACCORD) trial: Design and methods
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DOI：
10.1016/j.amjcard.2007.03.003
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发表时间：
2007-07-18
影响因子：
2.8
通讯作者：
Buse, John B.
中科院分区：
文献类型：
--
作者：
Buse, John B.
大多数2型糖尿病患者发生心血管疾病（CVD），预期寿命大幅缩短。非致命性CVD在很大程度上导致了糖尿病患者的医疗费用过高和生活质量下降。目前肥胖的流行提高了人们的期望，即与2型糖尿病相关的CVD将成为更大的公共卫生挑战。尽管这一健康问题的重要性，但缺乏关于强化控制糖尿病和其他CVD危险因素对2型糖尿病患者CVD事件发生率的影响的确切数据。控制糖尿病心血管风险的行动（雅阁）试验是一项随机、多中心、双2 × 2析因设计研究，涉及10，251例因现有CVD或其他风险因素而处于CVD事件高风险的中老年2型糖尿病受试者。雅阁正在测试3种药物治疗策略对降低CVD发病率和死亡率的影响。所有参与者都参加了这项试验，该试验正在测试一个假设，即以糖化血红蛋白（HbA（1c））水平< 6.0%为目标的治疗策略将比以HbA（1c）水平7.0%-7.9%为目标的策略更能降低CVD事件的发生率。血脂试验包括5,518名参与者，他们以双盲方式接受非诺贝特或安慰剂，以测试在良好血糖控制的情况下，一种治疗策略，使用贝特类药物增加高密度脂蛋白胆固醇和降低甘油三酯水平，同时使用3-羟基-3-甲基戊二酰辅酶A还原酶抑制剂（他汀类）降低低密度脂蛋白胆固醇，与使用他汀类药物加安慰剂的策略相比，密度脂蛋白胆固醇将降低CVD事件的发生率。血压试验包括剩余的4，733名参与者，并测试了以下假设：与目标收缩压<140 mm Hg的策略相比，在良好血糖控制的背景下，目标收缩压<120 mm Hg的治疗策略将降低CVD事件的发生率。所有3个研究问题的主要结局指标是首次发生重大CVD事件，特别是非致死性心肌梗死、非致死性卒中或心血管死亡。预计在2009年完成受试者随访后，雅阁试验应首次记录强化血糖控制、强化血压控制以及贝特类药物和他汀类药物联合治疗2型糖尿病高危患者血脂的获益和风险。(c)2007爱思唯尔公司All rights reserved.
Most patients with type 2 diabetes mellitus develop cardiovascular disease (CVD), with substantial loss of life expectancy. Nonfatal CVD contributes greatly to excess healthcare costs and decreased quality of life in patients with diabetes. The current epidemic of obesity has raised expectations that CVD associated with type 2 diabetes will become an even greater public health challenge. Despite the importance of this health problem, there is a lack of definitive data on the effects of the intensive control of glycemia and other CVD risk factors on CVD event rates in patients with type 2 diabetes. The Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial is a randomized, multicenter, double 2 X 2 factorial design study involving 10,251 middle-aged and older participants with type 2 diabetes who are at high risk for CVD events because of existing CVD or additional risk factors. ACCORD is testing the effects of 3 medical treatment strategies to reduce CVD morbidity and mortality. All participants are in the glycemia trial, which is testing the hypothesis that a therapeutic strategy that targets a glycosylated hemoglobin (HbA(1c)) level of < 6.0% will reduce the rate of CVD events more than a strategy that targets an HbA(1c) level of 7.0%-7.9%. The lipid trial includes 5,518 of the participants, who receive either fenofibrate or placebo in a double-masked fashion to test the hypothesis of whether, in the context of good glycemic control, a therapeutic strategy that uses a fibrate to increase high-density lipoprotein cholesterol and lower triglyceride levels together with a 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor (statin) to lower low-density lipoprotein cholesterol will reduce the rate of CVD events compared with a strategy that uses a statin plus a placebo. The blood pressure trial includes the remaining 4,733 participants and tests the hypothesis that a therapeutic strategy that targets a systolic blood pressure of < 120 mm Hg in the context of good glycemic control will reduce the rate of CVD events compared with a strategy that targets a systolic blood pressure of < 140 mm Hg. The primary outcome measure for all 3 research questions is the first occurrence of a major CVD event, specifically nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death. Upon the expected completion of participant follow-up in 2009, the ACCORD trial should document for the first time the benefits and risks of intensive glucose control, intensive blood pressure control, and the combination of fibrate and statin drugs in managing blood lipids in high-risk patients with type 2 diabetes. (c) 2007 Elsevier Inc. All rights reserved.