TRIAL OF ASPIRIN AND VITAMIN E IN WOMEN

阿司匹林和维生素 E 在女性中的试验

• 批准号: 2519315
• 负责人: CHARLES H HENNEKENS
• 金额: $ 147.3万
• 依托单位: BRIGHAM AND WOMEN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 1991
• 资助国家: 美国
• 起止时间: 1991-09-30 至 2001-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2519315
• 关键词: aspirin; cancer prevention; cardiovascular disorder epidemiology; cardiovascular disorder prevention; carotene; chemoprevention; clinical research; drug adverse effect; drug screening /evaluation; female; human middle age (35-64); human subject; human therapy evaluation; myocardial infarction; neoplasm /cancer epidemiology; nutrition aspect of cancer; nutrition related tag; postmenopause; stroke; tocopherols; vitamin therapy; women's health

This application proposes to extend treatment and follow-up in the Women's Health Study, an ongoing randomized, double-blind, placebo-controlled trial evaluating the benefits and risks of low-dose aspirin (100 mg on alternate days), vitamin E (600 IU on alternate days), and beta-carotene (50 mg on alternate days) ina the primary prevention of cardiovascular disease and cancer among approximately 40,000 US female health professionals, aged 45 years and older. The trial utilizes a 2x2x2 factorial design and is conducted entirely by mail using a streamlined, highly cost-efficient study protocol. Average duration of treatment and follow-up is currently 20.3 months, with 87% of randomized participants having at least one year and 47% having at least two years of follow-up. Currently, 90.8% of participants are taking all three study pills, and 93.2% are continuing ot take at least one pill. 98.7% of participants continue to provide complete morbidity data on questionnaires, and mortality follow-up is 99.7%. With continued excellent compliance and follow-up rates, at the conclusion of the proposed extension the trial will have 85-95% power to detect eh most plausible 25-30% benefits of low-dose aspirin, vitamin E, and beta-carotene on risks of the primary trial endpoint of important vascular events. Despite clear evidence of a benefit of low-dose aspirin on risk of a first myocardial infarction in men, no trial data have been collected in apparently healthy women, among whom the benefit-to-risk ratio for aspirin may be less favorable. Further, trial data are inadequate in both men and women on aspirin in primary prevention of stroke and cardiovascular death. As regards vitamin E and beta -carotene, while observational epidemiologic studies have shown that people with high intake of antioxidant vitamins, through diet or supplements, have lower risks of cardiovascular disease, randomized trial data are both lacking and necessary to establish whether the agents themselves are protective or the relationships seen in observational studies are due to uncontrolled or uncontrollable confounding. Thr proposed extension will enable the Women's Health Study to provide definitive tests of these important hypotheses, thereby allowing for the formulation of rational policy recommendations for the general public as well as informed clinical decision-making for individuals.

本申请建议延长妇女的治疗和随访， 健康研究，一项正在进行的随机、双盲、安慰剂对照试验 评估低剂量阿司匹林（100 mg，交替服用）的益处和风险 维生素E（600 IU，隔日）和β-胡萝卜素（50 mg， 在心血管疾病的初级预防中， 癌症在大约40，000名美国女性健康专业人员中，年龄为45岁 岁及以上。 该试验采用2x2x2析因设计， 完全通过邮件进行，采用精简、高成本效益的研究 议定书 目前治疗和随访的平均持续时间为20.3 个月，87%的随机参与者至少有一年， 47%的患者至少有两年的随访。 目前，90.8%的 参与者正在服用所有三种研究药物，93.2%的人继续服用 至少吃一片药。 98.7%的参与者继续提供完整的 问卷调查的发病率数据和死亡率随访为99.7%。 与 在结束时，继续保持良好的依从性和随访率 拟议的扩展试验将有85 - 95%的权力，以检测eh最 低剂量阿司匹林、维生素E和β-胡萝卜素的合理益处为25 - 30% 重要血管事件主要试验终点的风险。 尽管有明确的证据表明，低剂量阿司匹林对首次发病的风险有好处， 在男性心肌梗死中，没有收集到试验数据， 明显健康的女性，其中阿司匹林的获益风险比 可能不太有利。 此外，在男性和女性中的试验数据都不充分， 服用阿司匹林的妇女在预防中风和心血管死亡中的作用。 至于维生素E和β-胡萝卜素， 研究表明，摄入大量抗氧化维生素的人， 通过饮食或补充剂，降低心血管疾病的风险， 随机试验数据既缺乏，也有必要确定是否 代理人本身是保护性的， 观察性研究是由于不受控制或不可控的 真让人困惑 拟议的延期将使妇女健康研究 为这些重要的假设提供明确的测试，从而允许 制定合理的政策建议， 公众以及个人知情的临床决策。