Effect of folic acid and B vitamins on risk of cardiovascular events and total mortality among women at high risk for cardiovascular disease - A randomized trial
Effect of folic acid and B vitamins on risk of cardiovascular events and total mortality among women at high risk for cardiovascular disease - A randomized trial
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DOI：
10.1001/jama.299.17.2027
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发表时间：
2008-05-07
影响因子：
120.7
通讯作者：
Manson, JoAnn E.
中科院分区：
文献类型：
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作者：
Albert, Christine M.;Cook, Nancy R.;Manson, JoAnn E.
背景最近在既往心血管疾病(CVD)患者中进行的随机试验未能支持补充维生素B对心血管风险的益处。观察数据表明，女性的益处可能更大，但在已发表的随机试验中，女性的代表性一直较低。目的测试叶酸、维生素B6和维生素B12的组合是否降低患有和不患有心血管疾病的高危女性的心血管疾病风险。设计、设置和正在进行的抗氧化剂维生素随机试验的参与者，5442名年龄在42岁或以上、有心血管病史或有3种或更多冠状动脉危险因素的美国卫生专业人员参加了一项随机、双盲、安慰剂对照试验，接受含有叶酸、维生素B6和维生素B12的组合药片或匹配的安慰剂，从1998年4月到2005年7月，他们接受了7.3年的治疗。每天摄入2.5毫克叶酸、50毫克维生素B6和1毫克维生素B12。主要结果衡量心肌梗死、中风、冠状动脉血管重建或心血管疾病死亡率的综合结果。结果与安慰剂相比，共有796名女性经历了确诊的心血管事件(活动组406人，安慰剂组390人)。接受活性维生素治疗的患者在复合心血管疾病主要终点的风险相似(活性维生素与安慰剂组分别为226.9/10,000人年和219.2/10,000人年；相对风险[RR]，1.03；95%可信区间[CI]，0.90-1.19；P=。包括心肌梗死(34.5/10000人年vs39.5/10000人年；RR，0.87；95%CI，0.63-1.22；P=42)，卒中(41.9/万人年vs 36.8/万人年；RR，1.14；95%CI，0.82~1.57；P=。CVD死亡率(50.3/10000人年vs49.6/10000人年；RR，1.01；95%CI，0.76~1.35；P=。93)。在一项血液亚研究中，几何平均血浆同型半胱氨酸水平降低了18.5%(95%CI，12.5%-24.1%；P
Context Recent randomized trials among patients with preexisting cardiovascular disease ( CVD) have failed to support benefits of B- vitamin supplementation on cardiovascular risk. Observational data suggest benefits may be greater among women, yet women have been underrepresented in published randomized trials.Objective To test whether a combination of folic acid, vitamin B6, and vitamin B12 lowers risk of CVD among high- risk women with and without CVD.Design, Setting, and Participants Within an ongoing randomized trial of antioxidant vitamins, 5442 women who were US health professionals aged 42 years or older, with either a history of CVD or 3 or more coronary risk factors, were enrolled in a randomized, double- blind, placebo- controlled trial to receive a combination pill containing folic acid, vitamin B6, and vitamin B12 or a matching placebo, and were treated for 7.3 years from April 1998 through July 2005.Intervention Daily intake of a combination pill of 2.5 mg of folic acid, 50 mg of vitamin B6, and 1 mg of vitamin B12.Main Outcome Measures A composite outcome of myocardial infarction, stroke, coronary revascularization, or CVD mortality.Results Compared with placebo, a total of 796 women experienced a confirmed CVD event ( 406 in the active group and 390 in the placebo group). Patients receiving active vitamin treatment had similar risk for the composite CVD primary end point ( 226.9/ 10 000 person- years vs 219.2/ 10 000 person- years for the active vs placebo group; relative risk [ RR], 1.03; 95% confidence interval [ CI], 0.90- 1.19; P=. 65), as well as for the secondary outcomes including myocardial infarction( 34.5/10 000 person-years vs 39.5/ 10 000 person years; RR, 0.87; 95% CI, 0.63- 1.22; P=. 42), stroke ( 41.9/ 10 000 person- years vs 36.8/ 10 000 person- years; RR, 1.14; 95% CI, 0.82- 1.57; P=. 44), and CVD mortality( 50.3/ 10 000 person- years vs 49.6/ 10 000 person- years; RR, 1.01; 95% CI, 0.76- 1.35; P=. 93). In a blood substudy, geometric mean plasma homocysteine level was decreased by 18.5%( 95% CI, 12.5%- 24.1%; P