ACCORD (Action to Control Cardiovascular Risk in Diabetes)

ACCORD（控制糖尿病心血管风险的行动）

• 批准号: 8339773
• 负责人: EMILY Y CHEW
• 金额: $ 3.28万
• 依托单位: NATIONAL EYE INSTITUTE
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/8339773
• 关键词: Blood Glucose; Blood Pressure; Cardiovascular Diseases; Cardiovascular system; Cessation of life; Confidence Intervals; Congestive Heart Failure; Coronary Arteriosclerosis; Coronary heart disease; Diabetes Mellitus; Diabetic Angiopathies; Diabetic Retinopathy; Dyslipidemias; Eye; Fenofibrate; Fundus; Fundus photography; Goals; Hemoglobin; High Density Lipoprotein Cholesterol; High Density Lipoproteins; Hospitalization; Hypertension; Hypotension; LDL Cholesterol Lipoproteins; Lipids; Low-Density Lipoproteins; Masks; Measurement; Medical; Myocardial Infarction; Non-Insulin-Dependent Diabetes Mellitus; Odds Ratio; Ophthalmic examination and evaluation; Outcome; Participant; Patients; Persons; Phase; Placebos; Protocols documentation; Randomized; Randomized Clinical Trials; Randomized Controlled Clinical Trials; Recruitment Activity; Risk; Sample Size; Schedule; Serum; Simvastatin; Stroke; Triglycerides; arm; blood pressure regulation; cardiovascular risk factor; conventional therapy; design; follow-up; glycemic control; mortality; primary outcome; secondary outcome; stereoscopic

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).

控制糖尿病心血管风险的行动 (ACCORD) 是一项包含 3 个组成部分的随机临床试验，确定降低血糖、降低血压、降低血清甘油三酯以及提高血清高密度脂蛋白胆固醇水平对心血管疾病 (CVD) 的影响）2 型糖尿病患者。 10,000 名参与者将被随机分配到两个血糖管理治疗组，人数相等。强化治疗组将 目标是达到并维持糖化血红蛋白水平 < 6.0%。传统治疗组的目标 A1C 范围为 7.0-7.9%，预期平均值约为 7.5%。 其中 4,200 名参与者将同时随机接受两种高血压管理方案之一。强化治疗组的目标是收缩压 (SBP) < 120 mmHg，常规治疗组的目标是 SBP <140 mmHg。 5,800 名血脂异常 ACCORD 参与者（HDL < 40 mg/dl）将被随机分配 以双重掩蔽方式分配给安慰剂或非诺贝特 160 mg 每日 降低甘油三酯水平并增加高密度脂蛋白胆固醇水平， 通过他汀类药物治疗降低低密度脂蛋白胆固醇后 （辛伐他汀每天 20 毫克）将 LDL 水平目标控制在大约 100 毫克/分升或更低。 ACCORD 试验的主要终点是心血管原因导致的死亡， 非致命性心肌梗死和非致命性中风。次要结果包括： 主要结局加上任何冠状动脉血运重建的组合 疾病加充血性心力衰竭住院治疗；总死亡率、心血管疾病 死亡;上述任何一种特定的冠心病终点，并且是致命的 和非致命性中风。本研究还评估了其他微血管并发症 学习。一项辅助眼科研究旨在评估 ACCORD 试验中这些药物治疗对糖尿病视网膜病变的影响。 ACCORD 眼科研究包括 2 次眼科检查和 7 个立体视野的眼底摄影，计划在基线和第 4 年的随访中进行。预计样本量为 4065 名患者。主要的 ACCORD 试验是在 Vanguard 阶段之后进行的，从 2003 年 2 月到 2005 年 6 月招募了参与者并随机分组。ACCORD 眼科研究表明，强化血糖控制以及非诺贝特和他汀类药物的强化脂质治疗可降低糖尿病视网膜病变进展的风险。 4 年时，强化治疗后糖尿病视网膜病变的进展率为 7.3% 血糖治疗组的死亡率为 10.4%（调整后的比值比为 0.67； 95%置信区间CI，0.51至0.87； P = 0.003）； 6.5% 非诺贝特强化治疗 血脂异常治疗组，安慰剂组为 10.2%（调整后优势比，0.60； 95% CI，0.42 至 0.87； P = 0.006）； 10.4% 接受强化血压治疗， 相比之下，标准治疗为 8.8%（调整后优势比：1.23；95% CI，0.84 至 1.79； P = 0.29）。