Source: DGNews  |  Posted 3 years ago

By Charlene Laino

NEW ORLEANS -- November 10, 2008 -- Supplements of the antioxidants vitamin E and vitamin C failed to reduce the risk of major cardiovascular (CV) events in low-risk men, according to results of the large, longitudinal Physicians' Health Study II (PSH II).

Co-investigator J. Michael Gaziano, MD, MPH, Division of Preventive Medicine, Brigham and Women's Hospital, Boston, Massachusetts, presented the findings on November 9 during a late-breaking session at the American Heart Association (AHA) Scientific Sessions.

The findings were published online simultaneously in the []Journal of the American Medical Association[] (2008;300[18]. DOI:10.1001/jama.2008.600).

Despite the fact that basic research and observational studies suggest vitamin E or vitamin C may prevent CV disease (CVD), there have been surprisingly few long-term trials evaluating the supplements among men who are at low risk of CVD, Dr. Gaziano said.

To fill in the knowledge gap, Dr. Gaziano and colleagues evaluated the effects of vitamins E and C on the risk of CV events among 14,641 male physicians in the PSH II. Only 754 men (5.1%) had prevalent CVD at randomisation.

The men were randomised in a 2 x 2 factorial design to supplementation with vitamin E 400 IU every other day, vitamin C 500 mg daily, or placebo.

Over a mean follow-up of 8 years, vitamin E had no effect compared with placebo on the incidence of major CV events, a composite endpoint of nonfatal myocardial infarction (MI), nonfatal stroke, and CV-related deaths. Specifically, there were 620 events among the 7,315 men in the vitamin E arm versus 625 events among the 7,326 men the placebo arm (P = .86).

Also, vitamin E showed no benefit in preventing the individual endpoints of MI (P = .22), stroke (P = .[]45), or CV-related mortality (P = .43) compared with placebo, Dr. Gaziano said.

Vitamin C also failed to protect against major CV events (P = .91), MI (P = .65), stroke (P = .21), and CV-related deaths (P = .86)

Neither of the antioxidants had a significant effect on total mortality, but vitamin E increased by 74% the risk of haemorrhagic stroke (P = .04).

"Available trial data do not support the use of vitamin E and C supplementation as part of a comprehensive CVD prevention strategy in middle-aged and older men," Dr. Gaziano concluded.

Lead author Howard D. Sesso, MD, Division of Preventive Medicine, Brigham and Women's Hospital, said that patients should be "urged to focus on eating a healthy diet, exercising regularly, and controlling known risk factors such as high cholesterol and high blood pressure to reduce the risk of cardiovascular disease."

The study was funded by the National Institutes of Health and BASF Corporation with study agents and packaging provided by BASF Corporation, Wyeth Pharmaceuticals, and DSM Nutritional Products (formerly Roche Vitamins).

[Presentation title: A Randomized Factorial Trial of Vitamins E and C in the Prevention of Cardiovascular Disease and Mortality in Men: The Physicians' Health Study II. LBCT-Abstract 167]