Multivitamins in the Prevention of Cardiovascular Disease in Men The Physicians' Health Study II Randomized Controlled Trial

摘要

Context Although multivitamins are used to prevent vitamin and mineral deficiency, there is a perception that multivitamins may prevent cardiovascular disease (CVD). Observational studies have shown inconsistent associations between regular multivi-tamin use and CVD, with no long-term clinical trials of muitivitamin use.Objective To determine whether long-term muitivitamin supplementation decreases the risk of major cardiovascular events among men.Design, Setting, and Participants The Physicians' Health Study II, a randomized, double-blind, placebo-controlled trial of a common daily muitivitamin, began in 1997 with continued treatment and follow-up through June 1,2011. A total of 14 641 male US physicians initially aged 50 years or older (mean, 64.3 [SD, 9.2] years), including 754 men with a history of CVD at randomization, were enrolled.Intervention Daily muitivitamin or placebo.Main Outcome Measures Composite end point of major cardiovascular events, including nonfatal myocardial infarction (Ml), nonfatal stroke, and CVD mortality. Secondary outcomes included Ml and stroke individually.Results During a median follow-up of 11.2 (interquartile range, 10.7-13.3) years, there were 1732 confirmed major cardiovascular events. Compared with placebo, there was no significant effect of a daily muitivitamin on major cardiovascular events (11.0 and 10.8 events per 1000 person-years for muitivitamin vs placebo, respectively; hazard ratio [HR], 1.01; 95% Cl, 0.91-1.10; P=.91). Further, a daily muitivitamin had no effect on total Ml (3.9 and 4.2 events per 1000 person-years; HR, 0.93; 95% Cl, 0.80-1.09; P=.39), total stroke (4.1 and 3.9 events per 1000 person-years; HR, 1.06; 95% Cl, 0.91-1.23; P=.48), or CVD mortality (5.0 and 5.1 events per 1000 person-years; HR, 0.95; 95% Cl, 0.83-1.09; P= .47). A daily muitivitamin was also not significantly associated with total mortality (HR, 0.94; 95% Cl, 0.88-1.02; P=.13). The effect of a daily muitivitamin on major cardiovascular events did not differ between men with or without a baseline history of CVD (P= .62 for interaction). Conclusion Among this population of US male physicians, taking a daily muitivitamin did not reduce major cardiovascular events, Ml, stroke, and CVD mortality after more than a decade of treatment and follow-up.