Eye Supplement Use Could Have “Major” Public Health Impact, Study Says

If all those at risk for developing age-related macular degeneration received dietary supplements like Bausch & Lomb's Ocuvite PreserVision , more than 300,000 of them would avoid advanced AMD and any associated vision loss during the next five years, according to a study in the November Archives of Ophthalmology.

"If even half of the individuals at high risk for advanced AMD were identified and compliant with the recommended supplement, it is likely that more than 150,000 individuals would avoid vision loss for some time," the study points out.

"These data suggest that the recommendation of such a supplement for those individuals should have a major impact on them as well as on the public health."

The study was authored by researchers involved in the 2001 Age-Related Eye Disease Study, which was sponsored by the National Eye Institute, with support from Bausch & Lomb (¹ (Also see "Bausch & Lomb OcuVite Line Extension Used In Natl. Eye Institute Study" - Pink Sheet, 15 Oct, 2001.), p. 3).

Writing for the group, Neil Bressler, MD, et al. attempt to project the potential public health impact of the findings of AREDS over the next five years.

The original study found a supplement containing vitamins C and E, beta-carotene, zinc and copper can decrease the possibility of developing AMD by up to 25% in people at high risk for the disease. The treatment for the study was provided by Bausch & Lomb, which later commercialized the formula as Ocuvite PreserVision.

As the basis for their estimates, the researchers found approximately 8 mil. people at least 55 years old in the U.S. have monocular or binocular intermediate AMD or monocular advanced AMD.

"They are considered to be at high risk for advanced AMD and are those for whom the AREDS formulation should be considered," Bressler et al. state. Of that group, 1.3 mil. would develop advanced AMD if no treatment were given to reduce their risk, the researchers add.

Data were drawn from the Eye Disease Prevalence Study, a meta-analysis of seven large population-based studies of involving 20,000 people worldwide.

Researchers acknowledge several factors, such as the likelihood that not all patients "at high risk for advanced AMD" would take the supplement and that study participants were more compliant than real-world users, may have confounded results.

In an accompanying editorial, Lee Jampol, MD, Northwestern University Medical School, agrees the AREDS Study Group's results "appear reasonable." However, he also points out that during the trial, "after five years of supplementation, 72% of those at risk for advanced AMD were taking the proper dosage."

Jampol further notes in his own practice, only 13 of 31 eligible patients were taking the proper dose of the supplement "despite extensive efforts by me, my staff, fellow and residents to carefully explain" that four pills should be taken per day.

The editorial also states that some ophthalmologists do not effectively persuade patients to use the correct product. "They have allowed or even encouraged patients to use other antioxidant formulations, including some that contain a wide variety of unproven vitamins, minerals and other ingredients."

Jampol maintains that only the AREDS formula in the doses given during the study should be taken "because we do not know if lower dosages than the AREDS regimen are of any benefit."

He also notes that smokers and recent non-smokers are believed "to have a contraindication to large doses of beta-carotene, and are thus advised to be cautious in their use of the AREDS formulation." Although some smokers have tried taking a combination of the ingredients without beta carotene, only one such product currently is on the market.

"We cannot be certain (without data) that this new combination works as well," Jampol acknowledges, "but it is logical to try it in smokers."

The editorial addresses whether patients who have a history of AMD "or who for other reasons believe that they are at risk for the disease" might want to take the supplement in advance of potential development.

"This practice has been discouraged by the AREDS investigators and most opthalmologists," Jampol stresses. "This is not a multivitamin; if the patient needs additional vitamins (e.g. B vitamins or vitamin D), other products must be used."