Display Settings:

Format

Send to:

Choose Destination
See comment in PubMed Commons below
Ophthalmology. 2013 Aug;120(8):1604-11.e4. doi: 10.1016/j.ophtha.2013.01.021. Epub 2013 Apr 10.

Long-term effects of vitamins C and E, β-carotene, and zinc on age-related macular degeneration: AREDS report no. 35.

Collaborators (293)

Kassoff A, Kassoff J, Buehler J, Eglow M, Silverman S, Mehu M, Kieval S, Kaufman F, Mairs M, Graig B, Quattrocchi A, Jones D, Locatelli J, Ruby A, Capone A Jr, Garretson B, Hassan T, Trese MT, Williams GA, Regan V, Manatrey P, Streasick P, Szydlowski L, McIver F, Bridges C, Stanley C, Cumming K, Mitchell B, Holloway J, Lewis B, Zajechowski M, Margherio RR, Cox MS, Werner JC, Falk R, Siedlak P, Neubert C, Klein ML, Stout J, Lauer AK, Beardsley C, Anderson H, Wallace P, Smith G, Howard S, Dreyer RF, Ma C, Chenoweth RG, Zilis JD, O'Malley A, Robertson JE, Wilson DJ, Johnson M, Rice P, Daniel H, Crider H, Parker S, Sherman K, Martin DF, Aaberg TM Sr, Hubbard G, Garcia E, Curtis LT, DeLeon A, Myles B, Yi H, Capone A Jr, Lambert M, Meredith T, Aaberg TM Jr, Sternberg P Jr, Saperstein D, Lim JI, Stribling B, Ju B, Armiger D, Gilman J, Jordan D, Strittman S, Swords R, Orth DH, Flood TP, Civantos J, deBustros S, Packo KH, Merrill PT, Cohen JA, Chow D, Figliulo C, Morrison C, Bryant DA, Doherty D, McVicker M, Drefcinski T, Seddon JM, Pinnolis MK, Sachdeva M, Taytsel T, Burton I, Walsh D, Callahan C, Evans C, Snow KK, Jones-Devonish DA, Crouse VD, Rosenberg N, Davis N, Dubois-Moran J, Chew EY, Csaky K, Ferris FL 3rd, Shimel KH, Woods MA, Cunningham D, Kuehl EM, Palmer M, Babilonia-Ayukawa G, Foster GE, Kim YJ, Kivitz IJ, Koutsandreas D, LaReau A, Mercer RF, Nashwinter R, Rowan J, Short G, McCarthy SA, Ciatto PF, Ayres LM, Goodman L, Lopez P, Perry C, Randalls A, Friberg TR, Eller AW, Gorin MB, Mack B, Curtin DY, Ostroska PP, Fijewski E, Alexander J, Nixon S, Paine MK, Corbin PS, Warnicki J, Bressler SB, Bressler NM, Cassel G, Finkelstein D, Goldberg M, Haller JA, Ratner L, Schachat AP, Sherman SH, Sunness JS, Schenning S, Sackett C, Cain D, Emmert D, Herring M, McDonald J, Falk R, Wheeler S, Mcmillan M, George T, Elman MJ, Ballinger R, Betancourt A, Herr M, Lammlein J, Raden RZ, Seff R, Shuman M, Starr J, Firestone D, Sloan M, Sotirakos P, Cain T, Mathews T, Glasser D, Hirsch D, Killingsworth D, Kohlhepp P, Ringrose C, Carrigan A, Chandra SR, Gottlieb JL, Ip MS, Klein R, Nork T, Stevens TS, Blodi BA, Altaweel M, Klein BE, Davis MD, Olson M, Skoldberg A, Christianson E, Soderling B, Perry-Raymond JR, Burke K, Knutson G, Peterson J, Krolnik D, Harrison R, Somers G, Myers FL, Wallow I, Olsen TW, Bresnik G, De Venecia G, Perkins T, Walker W, Miller JL, Blatz M, Neider M, Wabers HD, Weber G, Amspaugh B, Buechner J, Lyngaas Myers HE, Davis MD, Klein BE, Klein R, Blodi B, Danis R, Hubbard L, Neider M, Vargo P, Wabers HD, Armstrong J, Benz W, Dohm KL, Fink C, Harding T, Hurtenbach C, Lang K, Reed S, Fisher MR, Gangnon R, Lee LY, Carr A, Baliker J, Kastorff L, Robinson N, Glander KE, Surfus J, Ansay S, Magli YL, Badal D, Craanen S, Elledge J, Esser B, Geithman PL, Miner KD, Reimers J, Webster M, Gai C, King W, Osterby K, Onofrey J, Brickbauer J, Schleicher RL, Miller DT, Sowell AL, Gunter EW, Bowman BA, Lindblad AS, Milton RC, Clemons TE, Gensler G, Rankin M, Henning A, Davis C, Entler G, McBee W, Stine E, Watson V, Berlin SH, Thotapally K, Jackson M, Tomlin K, Pallas S, Scholl PR, Mengers SA, Ederer F, Anand R, Roberts K, Ferris III FL, Sperduto RD, Kurinij N, Chew EY, SanGiovanni JP.

Author information

  • 1Division of Epidemiology and Clinical Applications, National Eye Institute/National Institutes of Health, Bethesda, Maryland 20892-1204, USA. echew@nei.nih.gov

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.

Copyright © 2013 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

PMID:
23582353
[PubMed - indexed for MEDLINE]
PMCID:
PMC3728272
Free PMC Article

Images from this publication.See all images (2)Free text

Figure 1
Figure 2
PubMed Commons home

PubMed Commons

0 comments
How to join PubMed Commons

    Supplemental Content

    Icon for Elsevier Science Icon for PubMed Central
    Loading ...
    Write to the Help Desk