Effects of vitamin E on cardiovascular and microvascular outcomes in high-risk patients with diabetes - Results of the HOPE study and MICRO-HOPE substudy
Effects of vitamin E on cardiovascular and microvascular outcomes in high-risk patients with diabetes - Results of the HOPE study and MICRO-HOPE substudy
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DOI：
10.2337/diacare.25.11.1919
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发表时间：
2002-11-01
期刊：
影响因子：
16.2
通讯作者：
Gerstein, HC
中科院分区：
文献类型：
--
作者：
Lonn, E;Yusuf, S;Gerstein, HC
目的：实验和观察性研究表明，维生素E可以降低糖尿病患者心血管事件和微血管并发症的风险。然而，来自随机临床试验的数据是有限的。因此，我们评估了补充维生素E对糖尿病患者主要心血管事件结局和肾病发展的影响。研究设计和方法-心脏结局预防评估(HOPE)试验是一项随机临床试验，采用2×2析因设计，评估维生素E和雷米普利在心血管事件高危患者中的效果。如果患者年龄在55岁或以上，如果他们患有心血管疾病或糖尿病，并至少有一个额外的冠状动脉风险因素，他们就有资格参加这项研究。这项研究旨在招募大量糖尿病患者，对这一群体中维生素E的影响分析是事先计划好的。患者被随机分配到每日服用400IU维生素E和10毫克雷米普利或各自的安慰剂，并平均随访4.5年。主要研究结果是心肌梗塞、中风或心血管死亡的综合结果。次要结果包括总死亡率、因心力衰竭住院、因不稳定心绞痛住院、血管重建和临床肾病。结果：综合主要结果的每个组成部分和所有预先确定的次要结果有3项主要研究结果(相对风险=1.03，95%可信区间0.88-1.21；P=0.70)。结论-每日服用400IU维生素E对患有糖尿病、心血管疾病和/或附加冠状动脉危险因素(S)的中老年患者平均4.5年的心血管转归或肾病没有影响。
OBJECTIVES - Experimental and observational studies suggest that vitamin E may reduce the risk of cardiovascular (CV) events and of microvascular complications in people with diabetes. However, data from randomized clinical trials are limited. Therefore, we evaluated the effects of vitamin E supplementation on major CV outcomes and on the development of nephropathy in people with diabetes.RESEARCH DESIGN AND METHODS - The Heart Outcomes Prevention Evaluation (HOPE) trial is a randomized clinical trial with a 2 X 2 factorial design, which evaluated the effects of vitamin E and of ramipril in patients at high risk for CV events. Patients were eligible for the study if they were 55 years or older and if they had CV disease or diabetes with at least one additional coronary risk factor. The study was designed to recruit a large number of people with diabetes, and the analyses of the effects of vitamin E in this group were preplanned. Patients were randomly allocated to daily treatment with 400 IU vitamin E and with 10 mg ramipril or their respective placebos and were followed for an average of 4.5 years. The primary study outcome was the composite of myocardial infarction, stroke, or CV death. Secondary outcomes included total mortality, hospitalizations for heart failure, hospitalizations for unstable angina, revascularizations, and overt nephropathy.RESULTS - There were 3, primary study outcome (relative risk = 1.03, 95% CI 0.88-1.21; P = 0.70), on each component of the composite primary outcome, and on all predefined secondary outcomes.CONCLUSIONS - The daily administration of 400 IU vitamin E for an average of 4.5 years to middle-aged and elderly people with diabetes and CV disease and/or additional coronary risk factor(s) has no effect on CV outcomes or nephropathy.