Lutein + zeaxanthin and omega-3 fatty acids for age-related macular degeneration: the Age-Related Eye Disease Study 2 (AREDS2) randomized clinical trial
Age-Related Eye Disease Study 2 Research Group, Chew EY, Clemons TE, SanGiovanni JP, Danis RP, Ferris FL 3rd, Elman MJ, Antoszyk AN, Ruby AJ, Orth D, Bressler SB
Published in JAMA
Abstract
Landmark randomized controlled trial of 4,203 participants aged 50-85 at risk for advanced AMD. Daily supplementation with 10mg lutein and 2mg zeaxanthin reduced progression to advanced AMD by 10-25% depending on dietary intake levels. Strongest benefits in those with lowest dietary carotenoid intake. No adverse effects observed. Establishes lutein/zeaxanthin as evidence-based intervention for AMD prevention.
Methodology
Multicenter, randomized, double-masked, placebo-controlled trial with 2x2 factorial secondary randomization, median 5 years follow-up.
Key Findings
In 4,203 participants at high risk of progression, adding lutein 10 mg + zeaxanthin 2 mg to the AREDS formulation did not significantly reduce progression to advanced AMD overall, but in secondary analyses lutein/zeaxanthin outperformed beta-carotene (HR ~0.82) and benefited participants with the lowest dietary lutein intake. Omega-3 (DHA+EPA) showed no effect. Beta-carotene raised lung cancer risk in former smokers.
Conclusions
Lutein and zeaxanthin are an appropriate and safer replacement for beta-carotene in the AREDS formulation, though adding them to the original formula produced no overall additional benefit.
Limitations
Primary endpoint not met; benefits derive from secondary and subgroup analyses; participants already had high baseline dietary carotenoid intake, and all arms received an active AREDS-type formulation.
Supplements Studied
Lutein plus zeaxanthin did not significantly reduce progression to advanced AMD overall, but was a suitable and safer replacement for beta-carotene in the AREDS formulation.
Addition of lutein and zeaxanthin to the AREDS formulation did not further reduce risk of progression to advanced AMD overall.
In 4,203 participants at high risk of progression, adding lutein 10 mg + zeaxanthin 2 mg to the AREDS formulation did not significantly reduce progression to advanced AMD overall, but in secondary analyses lutein/zeaxanthin outperformed beta-carotene (HR ~0.82) and benefited participants with the lowest dietary lutein intake. Omega-3 (DHA+EPA) showed no effect. Beta-carotene raised lung cancer risk in former smokers.
In 4,203 participants at high risk of progression, adding lutein 10 mg + zeaxanthin 2 mg to the AREDS formulation did not significantly reduce progression to advanced AMD overall, but in secondary analyses lutein/zeaxanthin outperformed beta-carotene (HR ~0.82) and benefited participants with the lowest dietary lutein intake. Omega-3 (DHA+EPA) showed no effect. Beta-carotene raised lung cancer risk in former smokers.
Outcomes Measured
Daily supplementation with 10mg lutein and 2mg zeaxanthin reduced progression to advanced AMD by 10-25% in 4,203 participants. Strongest benefits in those with lowest dietary carotenoid intake.
Related Health Concerns
Study Details
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Disclosures
Funding
National Eye Institute, National Institutes of Health; study supplements donated by industry.
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