Secondary analyses of the effects of lutein/zeaxanthin on age-related macular degeneration progression AREDS2 report no. 3

Emily Y. Chew, Traci E. Clemons, John Paul SanGiovanni, Ronald P. Danis, Frederick L. Ferris, Michael J. Elman, Andrew N. Antoszyk, Alan J. Ruby, David Orth, Susan B. Bressler, Gary E. Fish, George Baker Hubbard, Michael L. Klein, Suresh R. Chandra, Barbara A. Blodi, Amitha Domalpally, Thomas Friberg, Wai T. Wong, Philip J Rosenfeld, Elvira AgrónCynthia A. Toth, Paul S. Bernstein, Robert D. Sperduto

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Abstract

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.

Original languageEnglish
Pages (from-to)142-149
Number of pages8
JournalJAMA Ophthalmology
Volume132
Issue number2
DOIs
StatePublished - Feb 1 2014

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Lutein
Eye Diseases
Macular Degeneration
beta Carotene
Geographic Atrophy
Zeaxanthins
Unsaturated Fatty Acids
Vitamin E
Ascorbic Acid
Retina
Zinc
Copper
Lung Neoplasms
History
Placebos

ASJC Scopus subject areas

  • Ophthalmology

Cite this

Chew, E. Y., Clemons, T. E., SanGiovanni, J. P., Danis, R. P., Ferris, F. L., Elman, M. J., ... Sperduto, R. D. (2014). Secondary analyses of the effects of lutein/zeaxanthin on age-related macular degeneration progression AREDS2 report no. 3. JAMA Ophthalmology, 132(2), 142-149. https://doi.org/10.1001/jamaophthalmol.2013.7376

Secondary analyses of the effects of lutein/zeaxanthin on age-related macular degeneration progression AREDS2 report no. 3. / Chew, Emily Y.; Clemons, Traci E.; SanGiovanni, John Paul; Danis, Ronald P.; Ferris, Frederick L.; Elman, Michael J.; Antoszyk, Andrew N.; Ruby, Alan J.; Orth, David; Bressler, Susan B.; Fish, Gary E.; Hubbard, George Baker; Klein, Michael L.; Chandra, Suresh R.; Blodi, Barbara A.; Domalpally, Amitha; Friberg, Thomas; Wong, Wai T.; Rosenfeld, Philip J; Agrón, Elvira; Toth, Cynthia A.; Bernstein, Paul S.; Sperduto, Robert D.

In: JAMA Ophthalmology, Vol. 132, No. 2, 01.02.2014, p. 142-149.

Research output: Contribution to journalArticle

Chew, EY, Clemons, TE, SanGiovanni, JP, Danis, RP, Ferris, FL, Elman, MJ, Antoszyk, AN, Ruby, AJ, Orth, D, Bressler, SB, Fish, GE, Hubbard, GB, Klein, ML, Chandra, SR, Blodi, BA, Domalpally, A, Friberg, T, Wong, WT, Rosenfeld, PJ, Agrón, E, Toth, CA, Bernstein, PS & Sperduto, RD 2014, 'Secondary analyses of the effects of lutein/zeaxanthin on age-related macular degeneration progression AREDS2 report no. 3', JAMA Ophthalmology, vol. 132, no. 2, pp. 142-149. https://doi.org/10.1001/jamaophthalmol.2013.7376
Chew, Emily Y. ; Clemons, Traci E. ; SanGiovanni, John Paul ; Danis, Ronald P. ; Ferris, Frederick L. ; Elman, Michael J. ; Antoszyk, Andrew N. ; Ruby, Alan J. ; Orth, David ; Bressler, Susan B. ; Fish, Gary E. ; Hubbard, George Baker ; Klein, Michael L. ; Chandra, Suresh R. ; Blodi, Barbara A. ; Domalpally, Amitha ; Friberg, Thomas ; Wong, Wai T. ; Rosenfeld, Philip J ; Agrón, Elvira ; Toth, Cynthia A. ; Bernstein, Paul S. ; Sperduto, Robert D. / Secondary analyses of the effects of lutein/zeaxanthin on age-related macular degeneration progression AREDS2 report no. 3. In: JAMA Ophthalmology. 2014 ; Vol. 132, No. 2. pp. 142-149.
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abstract = "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.",
author = "Chew, {Emily Y.} and Clemons, {Traci E.} and SanGiovanni, {John Paul} and Danis, {Ronald P.} and Ferris, {Frederick L.} and Elman, {Michael J.} and Antoszyk, {Andrew N.} and Ruby, {Alan J.} and David Orth and Bressler, {Susan B.} and Fish, {Gary E.} and Hubbard, {George Baker} and Klein, {Michael L.} and Chandra, {Suresh R.} and Blodi, {Barbara A.} and Amitha Domalpally and Thomas Friberg and Wong, {Wai T.} and Rosenfeld, {Philip J} and Elvira Agr{\'o}n and Toth, {Cynthia A.} and Bernstein, {Paul S.} and Sperduto, {Robert D.}",
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T1 - Secondary analyses of the effects of lutein/zeaxanthin on age-related macular degeneration progression AREDS2 report no. 3

AU - Chew, Emily Y.

AU - Clemons, Traci E.

AU - SanGiovanni, John Paul

AU - Danis, Ronald P.

AU - Ferris, Frederick L.

AU - Elman, Michael J.

AU - Antoszyk, Andrew N.

AU - Ruby, Alan J.

AU - Orth, David

AU - Bressler, Susan B.

AU - Fish, Gary E.

AU - Hubbard, George Baker

AU - Klein, Michael L.

AU - Chandra, Suresh R.

AU - Blodi, Barbara A.

AU - Domalpally, Amitha

AU - Friberg, Thomas

AU - Wong, Wai T.

AU - Rosenfeld, Philip J

AU - Agrón, Elvira

AU - Toth, Cynthia A.

AU - Bernstein, Paul S.

AU - Sperduto, Robert D.

PY - 2014/2/1

Y1 - 2014/2/1

N2 - 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.

AB - 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.

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