COMMENTARY

AREDS2: No Cure, but Not a Failure

Brianne N. Hobbs, OD

Disclosures

June 11, 2013

Lutein + Zeaxanthin and Omega-3 Fatty Acids for Age-Related Macular Degeneration: The Age-Related Eye Disease Study 2 (AREDS2) Randomized Clinical Trial

The Age-Related Eye Disease Study 2 (AREDS2) Research Group
JAMA. 2013;309:2005-2015

Slowing the Progression of AMD

As a clinician, it is difficult to share with a patient the diagnosis of a condition for which there is no restorative treatment. Both clinicians and patients struggle with the intellectual and emotional implications of this situation. Clinicians are hesitant to admit to patients that no treatment can neutralize or reverse the disease process, because this admission evokes a sense of failure and vulnerability. Patients wrestle with accepting a diagnosis for which there is no clear-cut treatment that will lead to a cure.

Age-related macular degeneration (AMD) is an ocular condition that raises this quandary, for it cannot be cured. Slowing its progression seems to be the most achievable goal, so the original Age-Related Eye Disease Study[1] (AREDS) investigated the effects of antioxidant supplementation on the progression of AMD. The AREDS2 study sought to build on the findings of the AREDS1 study and explore the effect of specific carotenoids and omega-3 fatty acids on the development of exudative AMD and geographic atrophy.

Study Summary

The results of the AREDS2 trial, published in JAMA, have generated much anticipation in the optometric, ophthalmologic, and medical communities. More than 4000 patients were enrolled in this study, which was conducted at 83 clinical sites. Unilateral large drusen in 1 eye with advanced AMD in the fellow eye, or bilateral large drusen were the inclusion criteria because these findings were indicative of patients at high risk for progression to advanced AMD.

AREDS2 defined advanced AMD as the presence of choroidal neovascularization or central geographic atrophy. Participants enrolled in the study were randomly assigned to receive carotenoids (lutein and zeaxanthin), the omega-3 fatty acids docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA), or both, in addition to the original AREDS formula. There was no true placebo group in this study; the original AREDS formula served as the control.

A second randomization explored the effect of the elimination of beta-carotene and the reduction of zinc from 80 mg to 25 mg, because of complications from these components exposed by the original AREDS trial. The primary outcome measure was the number of patients in each group who developed advanced AMD.

The likelihood of progression hovered near 30% in all groups, indicating that the addition of carotenoids and omega-3 fatty acids did not significantly slow the course of the disease. A secondary outcome measure that was directly tied to a patient's quality of life -- the loss of 3 or more lines of acuity -- also did not statistically differ between groups. The elimination of beta-carotene and the alteration of zinc dosage had no effect on the rate of progression to advanced AMD. Beta-carotene increased the risk for lung cancer in smokers by 1.1%, but it did not alter mortality. Safety outcomes, including the number of serious adverse events and mortality, did not statistically differ between the groups.

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