Multivitamins in the prevention of cardiovascular disease in men: the Physicians' Health Study II randomized controlled trial.
What this study found
Daily multivitamin use did not reduce major cardiovascular events over a mean 11.2 years of follow-up. Major cardiovascular events were 876 versus 856 with multivitamin versus placebo, with adjusted HR 1.01 (0.91-1.10; P = .91). There was no meaningful effect on total MI, stroke, cardiovascular death, or total mortality. MI death was lower overall (27 vs 43; HR 0.61, 0.38-0.995; P = .048), but the authors noted this may have been due to chance; in men without baseline CVD, MI death remained lower (HR 0.56, 0.33-0.95; P = .03).
- Study & population
- This was a long-term randomized controlled trial in US male physicians aged 50 years or older enrolled in the Physicians' Health Study II.
- Intervention
- For the multivitamin arm, 7317 participants were randomized and analyzed.
- Key limitation
- The cohort was limited to older US male physicians, so generalizability is restricted.
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Open PDFOriginal abstract
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 multivitamin use and CVD, with no long-term clinical trials of multivitamin use. OBJECTIVE To determine whether long-term multivitamin 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 multivitamin, 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 multivitamin or placebo. MAIN OUTCOME MEASURES Composite end point of major cardiovascular events, including nonfatal myocardial infarction (MI), nonfatal stroke, and CVD mortality. Secondary outcomes included MI 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 multivitamin on major cardiovascular events (11.0 and 10.8 events per 1000 person-years for multivitamin vs placebo, respectively; hazard ratio [HR], 1.01; 95% CI, 0.91-1.10; P = .91). Further, a daily multivitamin had no effect on total MI (3.9 and 4.2 events per 1000 person-years; HR, 0.93; 95% CI, 0.80-1.09; P = .39), total stroke (4.1 and 3.9 events per 1000 person-years; HR, 1.06; 95% CI, 0.91-1.23; P = .48), or CVD mortality (5.0 and 5.1 events per 1000 person-years; HR, 0.95; 95% CI, 0.83-1.09; P = .47). A daily multivitamin was also not significantly associated with total mortality (HR, 0.94; 95% CI, 0.88-1.02; P = .13). The effect of a daily multivitamin 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 multivitamin did not reduce major cardiovascular events, MI, stroke, and CVD mortality after more than a decade of treatment and follow-up. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00270647.