Tags

Type your tag names separated by a space and hit enter

Long-term effects of vitamins C and E, β-carotene, and zinc on age-related macular degeneration: AREDS report no. 35.
Ophthalmology 2013; 120(8):1604-11.e4O

Abstract

OBJECTIVE

To describe the long-term effects (10 years) of the Age-Related Eye Disease Study (AREDS) formulation of high-dose antioxidants and zinc supplement on progression of age-related macular degeneration (AMD).

DESIGN

Multicenter, randomized, controlled, clinical trial followed by an epidemiologic follow-up study.

PARTICIPANTS

We enrolled 4757 participants with varying severity of AMD in the clinical trial; 3549 surviving participants consented to the follow-up study.

METHODS

Participants were randomly assigned to antioxidants C, E, and β-carotene and/or zinc versus placebo during the clinical trial. For participants with intermediate or advanced AMD in 1 eye, the AREDS formulation delayed the progression to advanced AMD. Participants were then enrolled in a follow-up study. Eye examinations were conducted with annual fundus photographs and best-corrected visual acuity assessments. Medical histories and mortality were obtained for safety monitoring. Repeated measures logistic regression was used in the primary analyses.

MAIN OUTCOME MEASURES

Photographic assessment of progression to, or history of treatment for, advanced AMD (neovascular [NV] or central geographic atrophy [CGA]), and moderate visual acuity loss from baseline (≥15 letters).

RESULTS

Comparison of the participants originally assigned to placebo in AREDS categories 3 and 4 at baseline with those originally assigned to AREDS formulation at 10 years demonstrated a significant (P<0.001) odds reduction in the risk of developing advanced AMD or the development of NV AMD (odds ratio [OR], 0.66, 95% confidence interval [CI], 0.53-0.83 and OR, 0.60; 95% CI, 0.47-0. 78, respectively). No significant reduction (P = 0.93) was seen for the CGA (OR, 1.02; 95% CI, 0.71-1.45). A significant reduction (P = 0.002) for the development of moderate vision loss was seen (OR 0.71; 95% CI, 0.57-0.88). No adverse effects were associated with the AREDS formulation. Mortality was reduced in participants assigned to zinc, especially death from circulatory diseases.

CONCLUSIONS

Five years after the clinical trial ended, the beneficial effects of the AREDS formulation persisted for development of NV AMD but not for CGA. These results are consistent with the original recommendations that persons with intermediate or advanced AMD in 1 eye should consider taking the AREDS formulation.

FINANCIAL DISCLOSURE(S)

The authors have no proprietary or commercial interest in any of the materials discussed in this article.

Authors+Show Affiliations

Division of Epidemiology and Clinical Applications, National Eye Institute/National Institutes of Health, Bethesda, Maryland 20892-1204, USA. echew@nei.nih.govNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, N.I.H., Extramural

Language

eng

PubMed ID

23582353

Citation

Chew, Emily Y., et al. "Long-term Effects of Vitamins C and E, Β-carotene, and Zinc On Age-related Macular Degeneration: AREDS Report No. 35." Ophthalmology, vol. 120, no. 8, 2013, pp. 1604-11.e4.
Chew EY, Clemons TE, Agrón E, et al. Long-term effects of vitamins C and E, β-carotene, and zinc on age-related macular degeneration: AREDS report no. 35. Ophthalmology. 2013;120(8):1604-11.e4.
Chew, E. Y., Clemons, T. E., Agrón, E., Sperduto, R. D., Sangiovanni, J. P., Kurinij, N., & Davis, M. D. (2013). Long-term effects of vitamins C and E, β-carotene, and zinc on age-related macular degeneration: AREDS report no. 35. Ophthalmology, 120(8), pp. 1604-11.e4. doi:10.1016/j.ophtha.2013.01.021.
Chew EY, et al. Long-term Effects of Vitamins C and E, Β-carotene, and Zinc On Age-related Macular Degeneration: AREDS Report No. 35. Ophthalmology. 2013;120(8):1604-11.e4. PubMed PMID: 23582353.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Long-term effects of vitamins C and E, β-carotene, and zinc on age-related macular degeneration: AREDS report no. 35. AU - Chew,Emily Y, AU - Clemons,Traci E, AU - Agrón,Elvira, AU - Sperduto,Robert D, AU - Sangiovanni,John Paul, AU - Kurinij,Natalie, AU - Davis,Matthew D, AU - ,, Y1 - 2013/04/10/ PY - 2012/10/26/received PY - 2013/01/07/revised PY - 2013/01/11/accepted PY - 2013/4/16/entrez PY - 2013/4/16/pubmed PY - 2013/11/7/medline SP - 1604 EP - 11.e4 JF - Ophthalmology JO - Ophthalmology VL - 120 IS - 8 N2 - OBJECTIVE: To describe the long-term effects (10 years) of the Age-Related Eye Disease Study (AREDS) formulation of high-dose antioxidants and zinc supplement on progression of age-related macular degeneration (AMD). DESIGN: Multicenter, randomized, controlled, clinical trial followed by an epidemiologic follow-up study. PARTICIPANTS: We enrolled 4757 participants with varying severity of AMD in the clinical trial; 3549 surviving participants consented to the follow-up study. METHODS: Participants were randomly assigned to antioxidants C, E, and β-carotene and/or zinc versus placebo during the clinical trial. For participants with intermediate or advanced AMD in 1 eye, the AREDS formulation delayed the progression to advanced AMD. Participants were then enrolled in a follow-up study. Eye examinations were conducted with annual fundus photographs and best-corrected visual acuity assessments. Medical histories and mortality were obtained for safety monitoring. Repeated measures logistic regression was used in the primary analyses. MAIN OUTCOME MEASURES: Photographic assessment of progression to, or history of treatment for, advanced AMD (neovascular [NV] or central geographic atrophy [CGA]), and moderate visual acuity loss from baseline (≥15 letters). RESULTS: Comparison of the participants originally assigned to placebo in AREDS categories 3 and 4 at baseline with those originally assigned to AREDS formulation at 10 years demonstrated a significant (P<0.001) odds reduction in the risk of developing advanced AMD or the development of NV AMD (odds ratio [OR], 0.66, 95% confidence interval [CI], 0.53-0.83 and OR, 0.60; 95% CI, 0.47-0. 78, respectively). No significant reduction (P = 0.93) was seen for the CGA (OR, 1.02; 95% CI, 0.71-1.45). A significant reduction (P = 0.002) for the development of moderate vision loss was seen (OR 0.71; 95% CI, 0.57-0.88). No adverse effects were associated with the AREDS formulation. Mortality was reduced in participants assigned to zinc, especially death from circulatory diseases. CONCLUSIONS: Five years after the clinical trial ended, the beneficial effects of the AREDS formulation persisted for development of NV AMD but not for CGA. These results are consistent with the original recommendations that persons with intermediate or advanced AMD in 1 eye should consider taking the AREDS formulation. FINANCIAL DISCLOSURE(S): The authors have no proprietary or commercial interest in any of the materials discussed in this article. SN - 1549-4713 UR - https://www.unboundmedicine.com/medline/citation/23582353/Long_term_effects_of_vitamins_C_and_E_β_carotene_and_zinc_on_age_related_macular_degeneration:_AREDS_report_no__35_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0161-6420(13)00036-5 DB - PRIME DP - Unbound Medicine ER -