December 13, 2004
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AREDS letter seeks to calm vitamin E concerns

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A recent study concluding that high doses of vitamin E may increase the risk of premature death has been widely covered in the consumer media and will be published in an upcoming issue of the Annals of Internal Medicine. Because vitamin E was one component of the multivitamin supplement used in the Age-Related Eye Disease Study, AREDS researchers have composed a letter to the study participants to clarify the implications of the vitamin E study for them.

The letter from the AREDS Coordinating Center to AREDS study participants is posted on the American Academy of Ophthalmology Web site in the public information section.

The letter notes that the study in question analyzed the “risk of death” by combining data from 19 clinical trials testing vitamin E as a possible treatment for many diseases, and that portions of the data from AREDS were included in the analysis. The meta-analysis included 15,000 patients and more than 1,600 total deaths in the generally elderly population, the letter states.

“We are writing to tell you about the results of this report and why we believe taking 400 IU of vitamin E as part of the AREDS formulation does not increase the risk of death of persons at risk for advanced AMD,” the letter to participants states.

The increased level of mortality was seen in patients taking higher doses of vitamin E — 500 IU to 2,000 — than the dose used in the AREDS, the letter points out. There was “essentially no difference in the risk of dying between those who took about 400 IU vitamin E and those who did not in a large number of patients studied,” the letter states.

While the letter notes that taking high doses of vitamin E to increase longevity does not seem to be beneficial, it points out that at lower doses, such as the 400 IU dose used in the AREDS, taking vitamin E to prevent the onset of AMD in those at high risk has been shown to be beneficial. The letter also reminds participants that the AREDS formulation also includes other vitamins and antioxidants that may play a role in slowing the progression of AMD.

In fact, the letter notes, when compared with participants taking placebo, those taking the AREDS formulation had a 12% reduction in 5-year mortality risk in the study.

The vitamin E study received wide publicity in the lay press when results were announced at the American Heart Association meeting in November. The full study is slated to be published in the January 2005 edition of the Annals of Internal Medicine, according to the AREDS letter.