高危患者补充维生素E与心血管事件

Vitamin E supplementation and cardiovascular events in high-risk patients.

作者信息

Yusuf S, Dagenais G, Pogue J, Bosch J, Sleight P

机构信息

Canadian Cardiovascular Collaboration Project Office, Hamilton General Hospital, ON.

出版信息

N Engl J Med. 2000 Jan 20;342(3):154-60. doi: 10.1056/NEJM200001203420302.

DOI:10.1056/NEJM200001203420302

PMID:10639540

Abstract

BACKGROUND

Observational and experimental studies suggest that the amount of vitamin E ingested in food and in supplements is associated with a lower risk of coronary heart disease and atherosclerosis.

METHODS

We enrolled a total of 2545 women and 6996 men 55 years of age or older who were at high risk for cardiovascular events because they had cardiovascular disease or diabetes in addition to one other risk factor. These patients were randomly assigned according to a two-by-two factorial design to receive either 400 IU of vitamin E daily from natural sources or matching placebo and either an angiotensin-converting-enzyme inhibitor (ramipril) or matching placebo for a mean of 4.5 years (the results of the comparison of ramipril and placebo are reported in a companion article). The primary outcome was a composite of myocardial infarction, stroke, and death from cardiovascular causes. The secondary outcomes included unstable angina, congestive heart failure, revascularization or amputation, death from any cause, complications of diabetes, and cancer.

RESULTS

A total of 772 of the 4761 patients assigned to vitamin E (16.2 percent) and 739 of the 4780 assigned to placebo (15.5 percent) had a primary outcome event (relative risk, 1.05; 95 percent confidence interval, 0.95 to 1.16; P=0.33). There were no significant differences in the numbers of deaths from cardiovascular causes (342 of those assigned to vitamin E vs. 328 of those assigned to placebo; relative risk, 1.05; 95 percent confidence interval, 0.90 to 1.22), myocardial infarction (532 vs. 524; relative risk, 1.02; 95 percent confidence interval, 0.90 to 1.15), or stroke (209 vs. 180; relative risk, 1.17; 95 percent confidence interval, 0.95 to 1.42). There were also no significant differences in the incidence of secondary cardiovascular outcomes or in death from any cause. There were no significant adverse effects of vitamin E.

CONCLUSIONS

In patients at high risk for cardiovascular events, treatment with vitamin E for a mean of 4.5 years had no apparent effect on cardiovascular outcomes.

摘要

背景

观察性和实验性研究表明，食物及补充剂中摄入的维生素E量与较低的冠心病和动脉粥样硬化风险相关。

方法

我们共纳入了2545名女性和6996名55岁及以上的男性，这些人因患有心血管疾病或糖尿病以及至少一项其他风险因素而属于心血管事件高危人群。这些患者按照2×2析因设计随机分组，分别每日接受400 IU天然来源的维生素E或匹配的安慰剂，以及血管紧张素转换酶抑制剂（雷米普利）或匹配的安慰剂，平均治疗4.5年（雷米普利与安慰剂比较的结果在另一篇相关文章中报道）。主要结局是心肌梗死、中风和心血管原因导致的死亡的复合事件。次要结局包括不稳定型心绞痛、充血性心力衰竭、血运重建或截肢、任何原因导致的死亡、糖尿病并发症和癌症。

结果

在分配到维生素E组的4761名患者中，共有772名（16.2%）发生了主要结局事件；在分配到安慰剂组的4780名患者中，有739名（15.5%）发生了主要结局事件（相对风险，1.05；95%置信区间，0.95至1.16；P = 0.33）。心血管原因导致的死亡人数（分配到维生素E组的有342人，分配到安慰剂组的有328人；相对风险，1.05；95%置信区间，0.90至1.22）、心肌梗死（532例对524例；相对风险，1.02；95%置信区间，0.90至1.15）或中风（209例对180例；相对风险，1.17；95%置信区间，0.95至1.42）均无显著差异。次要心血管结局的发生率或任何原因导致的死亡也无显著差异。维生素E没有显著的不良反应。