ACCORD

符合试验目的和设计(2006年6月30日)。2型糖尿病患者死于心血管疾病(CVD)的比率比人口统计特征相似的非糖尿病人群高出两到四倍。他们还经历了非致命性心肌梗死和中风的增加。随着肥胖症在美国的日益流行，与2型糖尿病相关的心血管疾病预计在未来几十年将成为比现在更大的公共卫生挑战。事故率的预期增加将伴随着痛苦和资源利用的增加。尽管这一健康问题在北美人群中很重要，但关于强化控制血糖和其他心血管危险因素对糖尿病患者心血管事件发生率的影响，缺乏明确的数据。控制糖尿病心血管风险的行动(ACCORD)试验的总体目标是通过测试针对2型糖尿病的三种互补的医疗治疗策略来应对这一挑战，以加强降低这种疾病中仍然很高的主要心血管疾病发病率和死亡率的选择。该设计为随机、多中心、双2×2析因设计，受试者为10,251名2型糖尿病患者。该试验旨在测试强化血糖控制、提高高密度脂蛋白胆固醇和降低甘油三酯的治疗(在良好的低密度脂蛋白和血糖控制的情况下)以及强化的血压控制(在良好的血糖控制的情况下)对主要心血管事件的影响。所有10,251名参与者都将参加主要的血糖试验。此外，一项2×2试验还将解决5518名参与者的血脂问题，另一项2×2试验将解决4733名参与者的血压问题。10,251名参与者将在美国和加拿大7个临床中心网络内的77个临床站点接受治疗和约4至8年(平均约5.6年)的跟踪治疗。招募工作分两个不连续的阶段进行：第一阶段是2001年1月开始的先锋阶段试验(在此期间随机抽查了1174名参与者)，第二阶段是从2003年1月开始至2005年10月结束。后续行动定于2009年6月结束，初步结果将于2010年初公布。欲了解更多信息，请访问www.accestrial.org。 ACCORD试验更新，2008年2月6日：“为安全起见，NHLBI改变了糖尿病和心血管疾病临床试验中的强化血糖治疗策略。”美国国立卫生研究院(National Institutes Of Health)的国家心肺血液研究所(NHLBI)在对现有数据进行审查后，出于安全考虑，提前18个月停止了正在进行的一项大型北美糖尿病和心血管疾病临床试验中的一种治疗，尽管这项研究将继续进行。在这项针对心脏病发作和中风风险特别高的成人2型糖尿病患者的试验中，与强度较低的标准治疗策略相比，将血糖(血糖)集中降至当前推荐水平以下的药物策略增加了死亡风险。接受强化降血糖治疗的研究参与者现在将接受较低强度的标准治疗。ACCORD(控制糖尿病心血管风险的行动)研究招募了10,251名参与者。在这些患者中，强化治疗组有257人死亡，而标准治疗组有203人死亡。在平均近四年的治疗期间，这意味着54人死亡，或每年每1000名参与者中有3人死亡。这两组人的死亡率都低于其他研究中类似人群的死亡率。欲了解更多信息，请登录：http://www.nhlbi.nih.gov/health/prof/heart/other/accord/.。 ACCORD眼科研究通过7个立体视野的2次眼底摄影检查来检查糖尿病视网膜病变，这些检查是在基准年(2003年)进行的，并在4到6年后进行了随访。这项子研究旨在评估ACCORD试验中这些药物治疗糖尿病视网膜病变的效果。

ACCORD Trial Purpose and Design (June 30, 2006). Patients with type 2 diabetes mellitus die of cardiovascular disease (CVD) at rates two to four times higher than non-diabetic populations of similar demographic characteristics. They also experience increased rates of nonfatal myocardial infarction and stroke. With the growing prevalence of obesity in the United States, CVD associated with type 2 diabetes is expected to become an even greater public health challenge in the coming decades than it is now. Expected increases in event rates will be associated with a concomitant rise in suffering and resource utilization. Despite the importance of this health problem in the North American population, there is a lack of definitive data on the effects of intensive control of glycemia and other CVD risk factors on CVD event rates in diabetic patients. The overall goal of the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial is to address this challenge by testing three complementary medical treatment strategies for type 2 diabetes to enhance the options for reducing the still very high rate of major CVD morbidity and mortality in this disease. The design is a randomized, multicenter, double 2 X 2 factorial design in 10,251 patients with type 2 diabetes mellitus. The trial is designed to test the effects on major CVD events of intensive glycemia control, of treatment to increase HDL-cholesterol and lower triglycerides (in the context of good LDL-C and glycemia control), and of intensive blood pressure control (in the context of good glycemia control). All 10,251 participants will be in the overarching glycemia trial. In addition, one 2 X 2 trial will also address the lipid question in 5,518 of the participants and the other 2 X 2 trial will address the blood pressure question in 4,733 of the participants. The 10,251 participants will be treated and followed for about 4 to 8 years (approximate mean of 5.6 years) at 77 Clinical Sites administratively located within 7 Clinical Center Networks in the United States and Canada. Recruitment occurred in two non-contiguous periods: an initial period that began in January 2001 for the Vanguard Phase of the trial (during which 1174 participants were randomized) and then a subsequent period beginning in January 2003 and ending in October 2005. Follow-up is scheduled to end in June 2009, with the primary results announced in early 2010. Additional information can be found at www.accordtrial.org. ACCORD Trial Update, February 6, 2008: "For Safety, NHLBI Changes Intensive Blood Sugar Treatment Strategy in Clinical Trial of Diabetes and Cardiovascular Disease." The National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health has stopped one treatment within a large, ongoing North American clinical trial of diabetes and cardiovascular disease 18 months early due to safety concerns after review of available data, although the study will continue. In this trial of adults with type 2 diabetes at especially high risk for heart attack and stroke, the medical strategy to intensively lower blood glucose (sugar) below current recommendations increased the risk of death compared with a less-intensive standard treatment strategy. Study participants receiving intensive blood glucose lowering treatment will now receive the less-intensive standard treatment. The ACCORD (Action to Control Cardiovascular Risk in Diabetes) study enrolled 10,251 participants. Of these, 257 in the intensive treatment group have died, compared with 203 within the standard treatment group. This is a difference of 54 deaths, or 3 per 1,000 participants each year, over an average of almost four years of treatment. The death rates in both groups were lower than seen in similar populations in other studies. Additional information can be found at: http://www.nhlbi.nih.gov/health/prof/heart/other/accord/. The ACCORD Eye Study examines diabetic retinopathy with 2 eye exams of fundus photography of 7 stereoscopic fields, done in the baseline year (2003) and followed up 4 to 6 years later. This substudy is designed to evaluate the effects of these medical treatments on diabetic retinopathy within the ACCORD Trial.