Schrier R W, Estacio R O, Jeffers B
Department of Medicine, University of Colorado Health Sciences Center, Denver, USA.
Diabetologia. 1996 Dec;39(12):1646-54. doi: 10.1007/s001250050629.
The ABCD (Appropriate Blood Pressure Control in Diabetes) Trial is a large, prospective, randomized clinical trial of 950 patients with non-insulin-dependent diabetes mellitus (NIDDM) designed to compare the effects of intensive blood pressure control with moderate control on the prevention and progression of diabetic nephropathy, retinopathy, cardiovascular disease, and neuropathy in NIDDM. The secondary objective is to determine equivalency of the effects of a calcium channel blocker (nisoldipine) and an angiotensin-converting-enzyme inhibitor (enalapril) as a first-line antihypertensive agent in the prevention and/or progression of these diabetic vascular complications. The study consists of two study populations aged 40-74 years, 470 hypertensive patients (diastolic blood pressure of > or = 90.0 mmHg at time of randomization) and 480 normotensive patients (diastolic blood pressure of 80.0 mmHg at time of randomization). The study duration is 5 years and is scheduled to end in May of 1998. Patients are randomized to receive either intensive antihypertensive drug therapy or moderate antihypertensive drug therapy. Patients are also randomized to nisoldipine or enalapril, with open-label medications added if further blood pressure control is necessary. The primary outcome measure is glomerular filtration rate as assessed by 24-h creatinine clearance. Secondary outcome measures are urinary albumin excretion, left ventricular hypertrophy, retinopathy, and neuropathy. Cardiovascular morbidity and mortality will also be evaluated. Given the data showing the impact of hypertension on complications in NIDDM, the ABCD Trial is designed to determine if intensive antihypertensive therapy will be more efficacious than moderate antihypertensive therapy on the outcome of diabetic complications in NIDDM.
ABCD（糖尿病患者血压适度控制）试验是一项针对950例非胰岛素依赖型糖尿病（NIDDM）患者的大型前瞻性随机临床试验，旨在比较强化血压控制与适度控制对NIDDM患者糖尿病肾病、视网膜病变、心血管疾病和神经病变的预防及进展的影响。次要目标是确定钙通道阻滞剂（尼索地平）和血管紧张素转换酶抑制剂（依那普利）作为一线抗高血压药物在预防和/或延缓这些糖尿病血管并发症方面的效果是否相当。该研究包括两个年龄在40 - 74岁的研究人群，470例高血压患者（随机分组时舒张压≥90.0 mmHg）和480例血压正常患者（随机分组时舒张压为80.0 mmHg）。研究持续时间为5年，计划于1998年5月结束。患者被随机分配接受强化抗高血压药物治疗或适度抗高血压药物治疗。患者还被随机分配接受尼索地平或依那普利治疗，如有必要进一步控制血压，则添加开放标签药物。主要结局指标是通过24小时肌酐清除率评估的肾小球滤过率。次要结局指标是尿白蛋白排泄、左心室肥厚、视网膜病变和神经病变。还将评估心血管发病率和死亡率。鉴于已有数据表明高血压对NIDDM并发症的影响，ABCD试验旨在确定强化抗高血压治疗在NIDDM患者糖尿病并发症结局方面是否比适度抗高血压治疗更有效。
