In a randomized study that included nearly 15,000 male physicians who were middle-aged or older, daily multivitamin use for more than 10 years of treatment and follow-up did not result in a reduction of major cardiovascular events, myocardial infarction, stroke or death from cardiovascular disease.
Reporting in the Nov. 7 issue of the Journal of the American Medical Association, Howard D. Sesso, ScD, MPH, of Brigham and Womens Hospital and Harvard Medical School, and colleagues analyzed data regarding multivitamin use and major cardiovascular events from the Physicians Health Study II.
A randomized, placebo-controlled trial that began in 1997 with continued treatment and follow-up through June 1, 2011, PHS II is a large-scale study to test the effects of long-term use of a common multivitamin on the risk of major cardiovascular events and cancer. A total of 14,641 male U.S. physicians initially age 50 or older (average age 64), including 754 men with a history of CVD at randomization, were enrolled.
During a median follow-up of 11.2 years, 1,732 men had major cardiovascular events, including 652 cases (first events) of MI and 643 cases of stroke, and 829 men died from cardiovascular causes, with some men experiencing multiple events.
In an analysis of the rate of events for men in each group, the researchers found no significant effect of a daily multivitamin on major cardiovascular events, or total MI or total stroke. Taking a daily multivitamin also was not significantly associated with a reduction in CVD mortality. There were fewer total deaths among multivitamin users, but this difference was not statistically significant, the researchers wrote.
The authors also found no significant effect of a daily multivitamin on rates of heart failure, angina and coronary revascularization. Also, the effect of a daily multivitamin on total MI, total stroke and other cardiovascular end points did not differ between men with and without CVD at the beginning of the study.
“The PHS II represents to our knowledge the only large-scale, randomized, double-blind, placebo-controlled trial testing the long-term effects of a commonly available multivitamin in the prevention of chronic disease,” the authors wrote. “These data do not support multivitamin use to prevent CVD, demonstrating the importance of long-term clinical trials of commonly used nutritional supplements.
“Whether to take a daily multivitamin requires consideration of an individuals nutritional status, because the aim of supplementation is to prevent vitamin and mineral deficiency, plus consideration of other potential effects, including a modest reduction in cancer and other important outcomes in PHS II that will be reported separately.”
In an accompanying editorial, Eva M. Lonn, MD, MSc, of McMaster University and Hamilton General Hospital, Hamilton, Ontario, wrote that “robust data from multiple trials clearly confirm that CVD cannot be prevented or treated with vitamins.
“Nonetheless, many people with heart disease risk factors or previous CVD events lead sedentary lifestyles, eat processed or fast foods, continue to smoke and stop taking lifesaving prescribed medications, but purchase and regularly use vitamins and other dietary supplements, in the hope that this approach will prevent a future myocardial infarction or stroke. This distraction from effective CVD prevention is the main hazard of using vitamins and other unproven supplements.
“The message needs to remain simple and focused: CVD is largely preventable, and can be achieved by eating healthy foods, exercising regularly, avoiding tobacco products and, for those with high risk factor levels or previous CVD events, taking proven, safe and effective medications.”
In addition to publication in JAMA, the study was scheduled for presentation Nov. 5 in Los Angeles at the American Heart Associations Scientific Sessions conference. The published version is available at http://jama.jamanetwork.com/article.aspx?articleid=1389615.