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Multivitamins in the prevention of cardiovascular disease in men: the Physicians' Health Study II randomized controlled trial.
JAMA. 2012 Nov 07; 308(17):1751-60.JAMA

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.

Authors+Show Affiliations

Division of Preventive Medicine, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School, Boston, MA 02215, USA. hsesso@hsph.harvard.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

23117775

Citation

Sesso, Howard D., et al. "Multivitamins in the Prevention of Cardiovascular Disease in Men: the Physicians' Health Study II Randomized Controlled Trial." JAMA, vol. 308, no. 17, 2012, pp. 1751-60.
Sesso HD, Christen WG, Bubes V, et al. Multivitamins in the prevention of cardiovascular disease in men: the Physicians' Health Study II randomized controlled trial. JAMA. 2012;308(17):1751-60.
Sesso, H. D., Christen, W. G., Bubes, V., Smith, J. P., MacFadyen, J., Schvartz, M., Manson, J. E., Glynn, R. J., Buring, J. E., & Gaziano, J. M. (2012). Multivitamins in the prevention of cardiovascular disease in men: the Physicians' Health Study II randomized controlled trial. JAMA, 308(17), 1751-60. https://doi.org/10.1001/jama.2012.14805
Sesso HD, et al. Multivitamins in the Prevention of Cardiovascular Disease in Men: the Physicians' Health Study II Randomized Controlled Trial. JAMA. 2012 Nov 7;308(17):1751-60. PubMed PMID: 23117775.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Multivitamins in the prevention of cardiovascular disease in men: the Physicians' Health Study II randomized controlled trial. AU - Sesso,Howard D, AU - Christen,William G, AU - Bubes,Vadim, AU - Smith,Joanne P, AU - MacFadyen,Jean, AU - Schvartz,Miriam, AU - Manson,JoAnn E, AU - Glynn,Robert J, AU - Buring,Julie E, AU - Gaziano,J Michael, PY - 2012/11/3/entrez PY - 2012/11/3/pubmed PY - 2012/11/9/medline SP - 1751 EP - 60 JF - JAMA JO - JAMA VL - 308 IS - 17 N2 - 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. SN - 1538-3598 UR - https://www.unboundmedicine.com/medline/citation/23117775/Multivitamins_in_the_prevention_of_cardiovascular_disease_in_men:_the_Physicians'_Health_Study_II_randomized_controlled_trial_ L2 - https://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2012.14805 DB - PRIME DP - Unbound Medicine ER -