ACCORD (Action to Control Cardiovascular Risk in Diabetes)

控制糖尿病心血管风险的行动（ACCORD）是一项随机临床试验，有3个组成部分，确定降低血糖、降低血压、降低血清甘油三酯和提高血清高密度脂蛋白胆固醇水平对2型糖尿病患者心血管疾病（CVD）的影响。10,000名参与者将被随机分配到两个血糖控制治疗组。强化治疗臂会

The Action to Control Cardiovascular Risk in Diabetes (ACCORD) is a randomized clinical trial with 3 components, determining the effects of blood glucose lowering, blood pressure lowering, and lowering of serum triglycerides plus raising serum high density lipoprotein cholesterol levels on cardiovascular disease (CVD) in patients with type 2 diabetes. 10,000 participants will be randomly assigned in equal numbers to two glycemic management treatment arms. An intensive treatment arm will aim to achieve and maintain hemoglobin A1C level < 6.0%. A conventional treatment arm will target an A1C range of 7.0-7.9% with an expected mean value of approximately 7.5%. 4,200 of these participants will simultaneously be randomized to one of two hypertension management protocols. The intensive treatment arm targets a systolic blood pressure (SBP) < 120 mmHg and the conventional treatment arm targets a SBP <140 mmHg. 5,800 dyslipidemic ACCORD participants (HDL < 40 mg/dl) will be randomly assigned in a double masked fashion to either a placebo or fenofibrate 160 mg daily for reduction of triglyceride levels and increase in high-density lipoprotein cholesterol levels, after low-density lipoprotein cholesterol has been lowered with statin therapy (simvastatin 20 mg daily) to target LDL levels of approximately 100 mg/dl or lower. The primary endpoint of the ACCORD Trial is death from cardiovascular causes, non-fatal myocardial infarction and non-fatal stroke. Secondary outcomes include: the combination of the primary outcome plus any revascularization for coronary artery disease plus hospitalization for congestive heart failure; total mortality, cardiovascular mortality; any one of the specific coronary heart disease endpoints noted above, and fatal and non-fatal strokes. Other microvascular complications were also assessed in this study. An ancillary eye study was designed to evaluate the effects of these medical treatments on diabetic retinopathy within the ACCORD Trial. The ACCORD Eye Study consists of 2 eye exams with fundus photography of 7 stereoscopic fields, scheduled for baseline and year 4 of follow-up. The projected sample size is 4065 patients. The main ACCORD Trial, which follows the Vanguard Phase, recruited and randomizes participantss from February 2003 through June 2005. The ACCORD Eye Study showed that intensive glycemic control and intensive lipid therapy with fenofibrate and a statin reduced the risk of progression of diabetic retinopathy. At 4 years, the rates of progression of diabetic retinopathy were 7.3% with intensive glycemia treatment, versus 10.4% with standard therapy (adjusted odds ratio, 0.67; 95% confidence interval CI, 0.51 to 0.87; P = 0.003); 6.5% with fenofibrate for intensive dyslipidemia therapy, versus 10.2% with placebo (adjusted odds ratio, 0.60; 95% CI, 0.42 to 0.87; P = 0.006); and 10.4% with intensive blood-pressure therapy, versus 8.8% with standard therapy (adjusted odds ratio: 1.23; 95% CI, 0.84 to 1.79; P = 0.29).