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Title: Antioxidants Reduce Visual Acuity Loss in Patients with Advanced Age-Related Macular Degeneration: Presented at AAO

"Antioxidants Reduce Visual Acuity Loss in Patients with Advanced Age-Related Macular Degeneration: Presented at AAO"

By Pippa Wysong CHICAGO, IL -- October 26, 2005 -- A formulation consisting of high-dose antioxidant vitamins and minerals reduced the 5-year risk of further loss of 3-line visual acuity in patients with advanced age-related macular degeneration (AMD), reported researchers at the annual meeting of the American Academy of Ophthalmology (AAO). The high-dose formulation has been shown to have beneficial effects in reducing by 25% the risk of advanced AMD, according to Thomas Friberg, MD, Professor of Ophthalmology, University of Pittsburgh, Pittsburgh, Pennsylvania, United States. During a presentation of the Age-Related Eye Disease Study (AREDS) here on October 14[^th, Dr. Friberg recommended high-dose antioxidant vitamins and minerals for patients who have an intermediate risk of AMD in one eye.

The goals of the study were to determine the effect of high-dose antioxidants on progression of vision loss in eyes with advanced AMD and to determine whether vitamin E had any effects on mortality.

The AREDS study was an 11-center, double-masked clinical trial which enrolled 4753 patients divided into four groups -- no AMD; early AMD; intermediate AMD; advanced AMD or vision loss due to AMD in one eye. Patients were followed for a median of 6.5 years. Overall mortality rate was 11%.

At baseline, 294 patients had advanced AMD, while an additional 540 progressed to advanced AMD during the study period.

Patients were randomly assigned to one of four treatment groups: The first group received three antioxidant vitamins: vitamin C 500 mg, vitamin E 400 IU, and beta carotene 15 mg. Group two received zinc oxide 80 mg, plus cupric acid 2 mg. The third group received the antioxidant vitamins plus the zinc and cupric oxide. Patients in the fourth group were given placebo.

After adjusting for age, sex, race, smoking status and baseline visual acuity, the researchers found that when compared to placebo, the group given antioxidant vitamins alone had a reduced risk of progression to further 3-line loss in visual acuity, Dr. Friberg said.

Treatment effect estimates in patients who were given zinc alone, and the antioxidants with zinc groups "were in the protective direction," he said.

When it came to the eyes that progressed to advanced disease during the study, the treatment effect was still in the direction of benefit, he added. These eyes were followed for a mean of 3.8 years.

As for mortality rates, death rates increased in relation to worsening macular pathology, and advanced AMD tended to be associated with cardiovascular deaths. Patients who had visual acuity <20/40 in one eye had significantly increased mortality when compared to patients who had good acuity in both eyes. Patients who took vitamins had no increased risk of mortality.

"In summary, it is safe to consider the AREDS formulation for patients with intermediate risk of AMD and those with advanced AMD in one eye," Dr. Friberg concluded.

[Presentation title: AREDS Formula and Vitamin E: Antioxidant Vitamins and Minerals for Advanced AMD and the Effects of Treatment on Mortality.]

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