May 7, 2013 – Results from a clinical trial known as the Age-Related Eye Disease Study 2 (AREDS2), conducted by the National Eye Institute (NEI), have led researchers to recommend replacing beta carotene with lutein and zeaxanthin in the original AREDS formula for reducing risk of advanced age-related macular degeneration (AMD). The study’s researchers believe that lutein and zeaxanthin appear to be more effective in reducing risk of wet AMD. In addition, beta carotene was linked to higher rates of lung cancer for current and former smokers.
The omega-3 fatty acids docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) were also evaluated in AREDS2 for reducing advanced AMD risk, but were not shown to be effective.
Results of the study were published on May 5, 2013, in The Journal of the American Medical Association.
“These results indicate that the AREDS formula can be modified to be safer and more effective for people at risk of advanced AMD,” says Paul Bernstein, M.D., Ph.D., the Mary H. Boesche Professor of Ophthalmology from the Moran Eye Center, University of Utah, and an AREDS2 investigator. “More than 10 million people in the U.S., and millions more around the world, have AMD, so this research can have a far-reaching impact.”
Launched in 2001, the original AREDS showed that a supplement comprised of specific amounts of beta carotene, vitamins C and E, zinc and copper reduced advanced AMD risk by 25 percent. Since 2001, many eye doctors have prescribed the over-the-counter supplement, often referred to as “the AREDS formula,” to their patients at risk for advanced AMD.
AREDS2 was launched in 2006 to determine if DHA, EPA, lutein and zeaxanthin would confer additional benefit in reducing advanced AMD risk.
“The take-home message from AREDS2 is that the original AREDS formula can be improved by replacing beta carotene with lutein and zeaxanthin,” says Stephen Rose, Ph.D., the Foundation’s chief research officer. “Also, current and former smokers should not take the original AREDS formula, because of beta carotene’s link to lung cancer.”
Several laboratory and small clinical studies over the past decade have suggested that lutein, zeaxanthin and the omega-3 fatty acids docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) might reduce the risk of advanced AMD. Results from those studies prompted the NEI, one of the federally funded National Institutes of Health, to launch AREDS2 to investigate the benefits of these nutrients in a large human study.
“AREDS2 underscores the important role of clinical research in determining the safety and effectiveness of potential and existing treatments,” says Dr. Rose.
More than 4,200 people between the ages of 50 and 85, all of whom were at risk of advanced AMD, were enrolled in AREDS2. Participants received the original AREDS formula or a modified formula with lower zinc and/or no beta carotene. They also received one of four AREDS2 regimens. Participants were randomly assigned the regimens and did not know which one they were taking.
People at risk of advanced AMD should only take AREDS and other supplements under doctor supervision.
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