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Original Investigation | Clinical Trial

Secondary Analyses of the Effects of Lutein/Zeaxanthin on Age-Related Macular Degeneration Progression:  AREDS2 Report No. 3

JAMA Ophthalmol. 2014;132(2):142-149. doi:10.1001/jamaophthalmol.2013.7376.
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Importance  The Age-Related Eye Disease Study (AREDS) formulation for the treatment of age-related macular degeneration (AMD) contains vitamin C, vitamin E, beta carotene, and zinc with copper. The Age-Related Eye Disease Study 2 (AREDS2) assessed the value of substituting lutein/zeaxanthin in the AREDS formulation because of the demonstrated risk for lung cancer from beta carotene in smokers and former smokers and because lutein and zeaxanthin are important components in the retina.

Objective  To further examine the effect of lutein/zeaxanthin supplementation on progression to late AMD.

Design, Setting, Participants  The Age-Related Eye Disease Study 2 is a multicenter, double-masked randomized trial of 4203 participants, aged 50 to 85 years, at risk for developing late AMD; 66% of patients had bilateral large drusen and 34% had large drusen and late AMD in 1 eye.

Interventions  In addition to taking the original or a variation of the AREDS supplement, participants were randomly assigned in a factorial design to 1 of the following 4 groups: placebo; lutein/zeaxanthin, 10 mg/2 mg; omega-3 long-chain polyunsaturated fatty 3 acids, 1.0 g; or the combination.

Main Outcomes and Measures  Documented development of late AMD by central, masked grading of annual retinal photographs or by treatment history.

Results  In exploratory analysis of lutein/zeaxanthin vs no lutein/zeaxanthin, the hazard ratio of the development of late AMD was 0.90 (95% CI, 0.82-0.99; P = .04). Exploratory analyses of direct comparison of lutein/zeaxanthin vs beta carotene showed hazard ratios of 0.82 (95% CI, 0.69-0.96; P = .02) for development of late AMD, 0.78 (95% CI, 0.64-0.94; P = .01) for development of neovascular AMD, and 0.94 (95% CI, 0.70-1.26; P = .67) for development of central geographic atrophy. In analyses restricted to eyes with bilateral large drusen at baseline, the direct comparison of lutein/zeaxanthin vs beta carotene showed hazard ratios of 0.76 (95% CI, 0.61-0.96; P = .02) for progression to late AMD, 0.65 (95% CI, 0.49-0.85; P = .002) for neovascular AMD, and 0.98 (95% CI, 0.69-1.39; P = .91) for central geographic atrophy.

Conclusion and Relevance  The totality of evidence on beneficial and adverse effects from AREDS2 and other studies suggests that lutein/zeaxanthin could be more appropriate than beta carotene in the AREDS-type supplements.

Trial Registration  clinicaltrials.gov Identifier: NCT00345176

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Figure 1.
Comparison of Lutein/Zeaxanthin vs No Lutein/Zeaxanthin for the Development of Late Age-Related Macular Degeneration (AMD), Neovascular AMD, and Central Geographic Atrophy

Analyses were conducted for all Age-Related Eye Disease Study 2 participants and then subdivided by the baseline AMD status: bilateral (OU) large drusen and bilateral large drusen with late AMD in 1 eye.

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Figure 2.
Comparison of Lutein/Zeaxanthin Plus Age-Related Eye Disease Study (AREDS) Supplements Without Beta Carotene (BC) vs AREDS Supplements With BC and No Lutein/Zeaxanthin

Head-to-head analysis of lutein/zeaxanthin vs BC for progression to late age-related macular degeneration (AMD) and the 2 forms of late AMD, neovascular AMD and central geographic atrophy. These were also subdivided by the baseline AMD status and bilateral (OU) large drusen or bilateral large drusen with late AMD in 1 eye. ATS indicates AREDS-type supplement.

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Figure 3.
Comparisons of Treatments

A, Comparison of lutein/zeaxanthin vs no lutein/zeaxanthin for effects on visual acuity (VA) loss (≥10 letters, ≥15 letters, and ≥30 letters lost compared with baseline) and the development of VA worse than 20/100. B, Comparison of lutein/zeaxanthin plus AREDS supplement without beta carotene (BC) vs AREDS formulation with beta carotene (without lutein/zeaxanthin) on VA outcomes. ATS indicates AREDS-type supplement.

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