Brown M J, Castaigne A, Ruilope L M, Mancia G, Rosenthal T, de Leeuw P W, Ebner F
Department of Medicine, University of Cambridge, UK.
J Hum Hypertens. 1996 Sep;10 Suppl 3:S157-60.
The objective of the study is to compare fatal and nonfatal cardiovascular endpoints in hypertensive patients randomised to the calcium-channel blocker, nifedipine GITS or a thiazide diuretic, co-amilozide. A total of 6592 patients from nine countries (UK, France, Israel, Spain, Italy, The Netherlands, Sweden, Denmark and Norway) will be recruited, aged 55-80 and with a blood pressure (BP) > or = 150/95 or > or = 160 mm Hg (systolic). All patients will have at least one other major cardiovascular risk factor. Patients will be minimised by country and risk factors and randomised to double-blind treatment with either nifedipine GITS or diuretic. After a single dose titration, additional treatment will be atenolol or enalapril (where beta-blockade is contra-indicated). After achieving a target BP of 140/90 mm Hg patients will be followed for a total of 3 years. Primary endpoints are myocardial infarction, stroke, subarachnoid haemorrhage, heart failure and sudden cardiac death. The study has a power of 80% at 5% significance to detect a difference between 8% event rate over 3 years in diuretic-treated patients and 6% in those receiving nifedipine.
该研究的目的是比较随机分配接受钙通道阻滞剂硝苯地平控释片（nifedipine GITS）或噻嗪类利尿剂复方阿米洛利（co-amilozide）治疗的高血压患者的致命和非致命心血管终点事件。将从九个国家（英国、法国、以色列、西班牙、意大利、荷兰、瑞典、丹麦和挪威）招募总共6592名患者，年龄在55至80岁之间，血压（BP）≥150/95或收缩压≥160 mmHg。所有患者将至少有一项其他主要心血管危险因素。患者将按国家和危险因素进行最小化处理，并随机接受硝苯地平控释片或利尿剂的双盲治疗。在单次剂量滴定后，额外的治疗药物将是阿替洛尔或依那普利（在禁忌使用β受体阻滞剂的情况下）。在达到目标血压140/90 mmHg后，患者将总共随访3年。主要终点是心肌梗死、中风、蛛网膜下腔出血、心力衰竭和心源性猝死。该研究在5%的显著性水平下有80%的检验效能，以检测利尿剂治疗患者3年8%的事件发生率与接受硝苯地平治疗患者6%的事件发生率之间的差异。
