Pharmavite urges for assessment of vitamin studies

13/03/06 Pharmavite LLC, maker of Nature Made(R) vitamins, urged careful assessment of two studies involving high doses of B vitamins given to patients with advanced disease. The company cautioned against making judgments about the study findings for healthy people, given that the study population in these trials had either advanced vascular disease or recently suffered a heart attack/stroke. Data from the two studies, HOPE-2 and NORVIT, will be presented at the American College of Cardiology's Annual Scientific Sessions in Atlanta, which begins March 11.

"Vitamins are meant to be taken for preventative measures to support long-term good health, rather than treat disease," said David Madsen, Ph.D., Pharmavite director of scientific affairs. "These studies test the wrong hypothesis. We should evaluate the impact of B vitamins taken by healthy people for a long duration."

HOPE-2 concluded that B vitamins did not reduce the risk of major cardiovascular events in older patients age 55+ with vascular disease.

Madsen identified several major problems in the HOPE-2 trial design:

-- Study population very selective: Participants had advanced vascular disease, were over the age of 55 years and taking a combination of medications.

-- Mixed population in terms of folate fortification: Some of the subjects were from countries with folate-fortification of food; others were from countries without such fortification. This may be related to the fact that more than 70 percent of those studied were not deficient in folic acid, a B vitamin. "This likely reduced the number of patients who would most likely benefit from B vitamin supplementation," he said.

-- Duration: The five-year trial many not have been long enough to have a good chance to detect reliably plausible effects of homocysteine lowering on cardiovascular risk. "The data, in fact, show the beginnings of a difference only after three years, and one wonders if a longer trial would have reached the desired statistical difference."

Design concerns for the NORVIT trial include the following:

-- Duration: As with the HOPE-2 trial, the study duration may not have been long enough to generate an impact.

-- Patient diet: NORVIT was conducted in Scandinavian patients who typically consume a diet rich in fish -- which contain heart-healthy omega 3 fatty acids. This might have impacted the study results.

Previous vitamin B studies are consistent in showing that they can help lower homocysteine levels and maintain cardiovascular health. For example, one major study suggests that a 25 percent decrease in homocysteine is associated with an approximate 10 percent decrease in the risk of coronary heart disease and a 20 percent decrease in the risk of stroke.

For more than 30 years, Pharmavite has earned and maintained the trust of pharmacists, consumers and retailers by manufacturing high-quality vitamins, minerals, herbs and other dietary supplements that are safe, effective and science-based. An industry leader, Pharmavite adheres to manufacturing standards recommended by the United States Pharmacopeia (USP), a not-for-profit organization that has set pharmaceutical and dietary supplement quality standards since 1820. In addition, Pharmavite participates in USP's Verification Program for dietary supplements.

The dietary supplement industry is regulated by the U.S. Food and Drug Administration and the Federal Trade Commission, as well as by government agencies in each of the 50 states.

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