Design of the collaborative AtoRvastatin Diabetes Study (CARDS) in patients with Type 2 diabetes
Design of the collaborative AtoRvastatin Diabetes Study (CARDS) in patients with Type 2 diabetes
复制标题
DOI：
10.1046/j.1464-5491.2002.00643.x
复制
发表时间：
2002-03-01
影响因子：
3.5
通讯作者：
Fuller, JH
中科院分区：
文献类型：
--
作者：
Colhoun, HM;Thomason, MJ;Fuller, JH
背景关于降脂在糖尿病患者冠心病一级预防中的作用的数据很少。本文描述了一项由英国糖尿病协会、英国国家医疗服务体系研究与发展局和英国辉瑞公司共同设计的针对这一问题的联合临床试验。方法联合阿托伐他汀糖尿病研究(CADS)是一项关于2型糖尿病患者心血管疾病一级预防的多中心、随机、安慰剂对照、双盲临床试验。主要目的是调查羟甲基戊二酰辅酶A还原酶抑制剂阿托伐他汀治疗是否能降低主要心血管事件的发生率。在入院时，除糖尿病外，患者至少还有一个患冠心病的危险因素，即当前吸烟、高血压、视网膜病变或微量或大量白蛋白尿。随机选择血清低密度脂蛋白胆固醇浓度小于等于4.14mmo1/L(160mgdl)和甘油三酯小于等于6.78mmoL/L(600mgdl)的患者。随机化于2001年6月完成。将对患者进行跟踪，直到304个主要终点出现为止(预计日期为2005年初)。这项试验包括2838名年龄在40岁至75岁之间的男性和女性。这份报告描述了这项研究的设计和实施，并回顾了到目前为止降脂治疗对2型糖尿病有效的证据。结论降脂治疗作为糖尿病冠心病一级预防的证据尚未得到证实。CARD将提供有关降脂治疗对无冠心病病史的糖尿病患者的任何益处和不良反应的程度的基本信息。
Background There are few data on the role of lipid lowering in the primary prevention of coronary heart disease (CHD) in diabetic patients. This paper describes the design of a collaborative clinical trial between Diabetes UK, the NHS Research and Development Directorate and Pfizer UK, that addresses this question.Methods The Collaborative AtoRvastatin Diabetes Study (CARDS) is a multicentre, randomized, placebo-controlled, double-blind clinical trial of primary prevention of cardiovascular disease in patients with Type 2 diabetes. The primary objective is to investigate whether treatment with the hydroxymethylglutaryl coenzyme A reductase inhibitor, atorvastatin, reduces the incidence of major cardiovascular events. At entry patients have at least one other risk factor for CHD in addition to diabetes, namely current smoking, hypertension, retinopathy, or micro- or macroalbuminuria. At randomization patients have been selected for a serum low-density lipoprotein (LDL) cholesterol concentration less than or equal to 4.14 mmol/l (160 mg/dl) and triglycerides less than or equal to 6.78 mmol/l (600 mg/dl). Randomization was completed in June 2001. Patients will be followed until 304 primary endpoints have accrued (expected date early 2005). The trial includes 2838 men and women aged 40-75 years. This report describes the design and administration of the study and reviews the evidence to date of the effectiveness of lipid-lowering therapy in Type 2 diabetes.Conclusions The case for lipid-lowering therapy for the primary prevention of CHD in diabetes has not been demonstrated. CARDS will provide essential information on the extent of any benefits and adverse effects of lipid-lowering therapy in diabetic patients without prior CHD.