Oxford 'Heart Protection Study' Proves Antioxidants Safe

NORTHRIDGE, Calif.--(BUSINESS WIRE)--Nov. 13, 2001--Six years of testing on more than 20,000 people at risk for coronary heart disease proved the safety of antioxidant vitamins E, C and beta-carotene (a form of vitamin A) for this special population, which includes smokers and those at risk for stroke.

The study findings were announced today at the American Heart Association's annual meeting in Anaheim, Calif. The double-blind, placebo-controlled 'Heart Protection Study' (HPS) was conducted by the University of Oxford in Oxford, England, and was designed to assess the efficacy of Zocor (simvastatin), a Merck heart drug and/or antioxidants, on people at risk for chronic heart disease.

"This highly-focused, exhaustive study supports a conclusion that people taking statin-based heart medication may safely supplement their diet with antioxidant vitamins, since the study did not produce any evidence of antioxidants interfering with prescription heart medication," said Joy Joseph, vice president, quality, technical operations and product development for Pharmavite. The Northridge, Calif.-based manufacturer of the Nature Made brand of vitamins, produced the antioxidant capsules used in the study.

Merck and Hoffman-La Roche Ltd., funded the study. The raw materials used in the antioxidant capsules were provided by Hoffman-La Roche. Since the HPS study was conducted solely on people with a serious disease state, Joseph said making correlations between study results and its implications for the entire population is inappropriate.

"While this HPS reinforced the safety of antioxidants among individuals at high-risk for cardiovascular events, it does not address the general population, who need preventive, not therapeutic options," said Joseph. "Antioxidants have and should be evaluated for their preventive health benefits," she said. According to the American Heart Association, up to 30 percent of Americans take some form of antioxidant dietary supplement.

Several studies have shown the preventive benefits of antioxidant vitamins. Joseph cited a Harvard University study on 39,000 subjects published in the New England Journal of Medicine. The Harvard study showed men who took at least 100 International Units of vitamin E daily had a 39 percent lower risk of developing coronary artery disease, compared with a control group of men who did not take vitamin E. Similar findings were noted in women.(1) And in a randomized controlled trial published in March, groups taking vitamin C and beta-carotene showed significant decreases in "bad" cholesterol levels, compared with a control group.(2)

(1) Rimm EB, Stampfer MJ, Ascherio A, et al, "Vitamin E consumption and the risk of coronary heart disease in men." Department of Epidemiology, Harvard School of Public Health. N Engl J Med. 1993 May 20;328(20):1450-6.

(2) Singhal S, Gupta R, Goyle A. "Comparison of antioxidant efficacy of vitamin E, vitamin C, vitamin A and fruits in coronary heart disease: a controlled trial." Department of Home Science, University of Rajasthan, Jaipur, India. J Assoc Physicians India 2001 Mar;49:327-31.