TWO NEW STUDIES IN NEW ENGLAND JOURNAL OF MEDICINE PROVIDE POSITIVE RESULTS FOR B-VITAMINS

WASHINGTON, DC, November 28, 2001— The New England Journal of Medicine published two articles in the November 29, 2001 issue that support the use of B-vitamin therapy for patients with cardiovascular disease.

According to Cathy Fomous, Ph.D., vice president, scientific research evaluation, Council for Responsible Nutrition, one of the dietary supplement industry’s leading trade associations, "While these therapeutic uses of vitamins should be clearly distinguished from ordinary supplement use, these two new studies illustrate the potential for vitamins to play an important role as adjuncts to medical therapy."

The first study*–conducted among 205 patients who had undergone coronary angioplasty–found that treatment with folic acid (1 milligram), vitamin B₁₂ (400 micrograms) and vitamin B₆ (10 milligrams) for six months significantly reduced the risk of the artery reclosing and lowered the incidence of major cardiac events (e.g., death or nonfatal heart attack). The study authors concluded, "This inexpensive treatment, which has minimal side effects, should be considered as adjunctive therapy for patients undergoing coronary angioplasty."

In the second study**, researchers found that combining niacin (nicotinic acid, a B-vitamin) with the cholesterol-lowering drug simvastatin dramatically improved the clinical outcome among 160 patients with coronary disease and low levels of high-density lipoprotein (HDL) cholesterol (the "good" cholesterol). The study was conducted over three years, and the patients began with 250 milligrams of slow-release niacin twice a day, which was increased to 1000 milligrams twice a day over four weeks. The combined therapy reduced the rate of major cardiac events (e.g., death, nonfatal heart attack, stroke) by 90 percent compared with the patients taking placebo. Additionally, the niacin-simvastatin treatment raised the levels of HDL cholesterol by 26 percent and was associated with a regression of plaque in the arteries. The benefits of the combined therapy were greater than those expected from simvastatin alone.

As part of the niacin-simvastatin study, the researchers also examined the effect of antioxidants–natural vitamin E (1000 IU), vitamin C (1000 milligrams), natural beta-carotene (25 milligrams) and selenium (100 micrograms). A group of patients received antioxidants alone, and another group received antioxidants plus the niacin-simvastatin combination. These groups were compared to subjects who received placebo and the niacin-simvastatin combination. While antioxidants alone slowed the progression of stenosis (narrowing of the arteries) compared to placebo, the niacin-simvastatin combination without antioxidants gave the best clinical results. It is important to note that the antioxidant doses used in the study were much higher than those typically found in multivitamins and many single-ingredient vitamin products.

"The B-vitamin results are very exciting," said John Cordaro, president and chief executive officer, Council for Responsible Nutrition. "The positive outcome, the minimal side effects, and the low cost of these therapies make their use very appealing."

The Council for Responsible Nutrition (CRN), founded in 1973, is a science-based trade association representing more than 100 companies in the dietary supplement industry including ingredient suppliers and manufacturers. CRN members adhere to a strong code of ethics, comply with dosage limits and manufacture dietary supplements to high quality standards under good manufacturing practices.

*New England Journal of Medicine, November 29, 2001, Vol. 345, No. 22: pgs.1593-1600

**New England Journal of Medicine, November 29, 2001, Vol. 345, No. 22: pgs.1583-1592

Note to Editor: To arrange an interview with John Cordaro, president & CEO, Council for Responsible Nutrition or Cathy Fomous, Ph.D., v.p., scientific research evaluation, please contact Judy Blatman at 202-263-1005.