AREDS trial

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Systematic review and meta-analysis

This trial is included in the following systematic reviews and meta-analyses:

cardiovascular prevention - antioxydants - all type of patients

cardiovascular prevention - antioxydants - primary prevention

POPADAD (antioxydant), 2008 - combination vs placebo

ARISE, 2008 - succinobucol vs placebo

PHS II vitamin E, 2008 - vitamin E vs placebo

PHS II vitamin C, 2008 - vitamin C vs placebo

WACS vitamin E, 2007 - vitamin E vs placebo

WACS vitamin C, 2007 - vitamin C vs placebo

WACS beta-caroten, 2007 - beta carotene vs placebo

SUVIMAX, 2005 - combination vs placebo

WHS vitamin E, 2005 - vitamin E vs placebo

PHS II beta carotene, 2003 - combination vs placebo

Tepel, 2003 - acetylcysteine vs placebo

WAVE (Waters), 2002 - combination vs placebo

HPS antioxidant, 2002 - combination vs placebo

PPP, 2001 - vitamin E vs control

AREDS, 2001 - vitamin E vs placebo

HATS, 2001 - combination vs placebo

ASAP, 2000 - vitamin E vs placebo

HOPE, 2000 - vitamin E vs placebo

NSCP (Green) beta carotene, 1999 - beta carotene vs placebo

WHS beta carotene, 1999 - beta carotene vs placebo

GISSI, 1999 - vitamin E vs control

MVP, 1997 - combination vs placebo

PHS beta carotene, 1996 - beta carotene vs placebo

CARET beta carotene, 1996 - beta carotene vs placebo

Treatments

Studied treatment	daily supplementation of antioxidants (500 mg of vitamin C, 400 IU of vitamin E, and 15 mg of beta carotene)
Control treatment	placebo
Remarks	patients with more than a few small drusen were also randomly assigned to receive tablets with or without zinc (80 mg of zinc as zinc oxide) and copper (2 mg of copper as cupric oxide) as part of the age-related macular degeneration trial

Patients

patients with age-related lens opacities and visual acuity loss

Exclusion criteria

illness or disorders (eg, history of cancer with a poor 7-year prognosis, major cardiovascular or cerebrovascular event within the last year, or hemachromatosis) that would make long-term follow-up or compliance with the study protocol unlikely or difficult

Baseline characteristics

Women (%)	55%
age (yr)	56 (median)

Method and design

Randomized effectives	2370 / 2387 (studied vs. control)
Design	Factorial plan
Blinding	double-blind
Follow-up duration	6.3 y
Number of centre	11
Geographic area	USA
Hypothesis	Superiority
Primary endpoint	opacity grades or cataract surgery
Studied endpoints	opacity grades or cataract surgery; at least moderate visual acuity loss from baseline

Results

Endpoint Studied treat.
n/N Control treat.
n/N Graph RR [95% CI]

All cause death

251 / 2370
240 / 2387
1,05 [0,89;1,25] 0 2 1.0

Endpoint	Events (%)		Relative Risk	95% CI	Endpoint definition in the trial	Ref
Relative risks
Endpoint	Studied treat.	Control treat.	Relative Risk	95% CI	Endpoint definition in the trial	Ref
All cause death	251 / 2370 (10,6%)	240 / 2387 (10,1%)	1,05	[0,89;1,25]		2938
The primary endpoint (if exists) appears in blod characters
Reference(s) used for data extraction: 2938: A randomized, placebo-controlled, clinical trial of high-dose supplementation with vitamins C and E and beta carotene for age-related cataract and vision loss: AREDS report no. 9.Arch Ophthalmol 2001 Oct;119:1439-52 0:

Endpoint	Events rate		Absolute risk reduction (ARR)
Absolute risk reduction (for a follow-up of 6.3 y)
Endpoint	Studied treat.	Control treat.	Absolute risk reduction (ARR)
All cause death	10,59%	10,05%	0,54%

Meta-analysis of all similar trials:

antioxydants in cardiovascular prevention for all type of patients

antioxydants in cardiovascular prevention for primary prevention

Reference(s)

TrialResults-center ID	TRC3709
Trials register #	NA

. A randomized, placebo-controlled, clinical trial of high-dose supplementation with vitamins C and E and beta carotene for age-related cataract and vision loss: AREDS report no. 9.. Arch Ophthalmol 2001 Oct;119:1439-52
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