Related trials
PHS II vitamin C, 2008 - vitamin C vs placebo
POPADAD (antioxydant), 2008 - combination vs placebo
ARISE, 2008 - succinobucol vs placebo
PHS II vitamin E, 2008 - vitamin E vs placebo
WACS beta-caroten, 2007 - beta carotene vs placebo
WACS vitamin E, 2007 - vitamin E vs placebo
WACS vitamin C, 2007 - vitamin C vs placebo
WHS vitamin E, 2005 - vitamin E vs placebo
SUVIMAX, 2005 - combination vs placebo
HOPE renal insufficiency subgroup, 2004 - 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
HATS, 2001 - combination vs placebo
PPP, 2001 - vitamin E vs control
AREDS, 2001 - vitamin E vs placebo
HOPE, 2000 - vitamin E vs placebo
ASAP, 2000 - vitamin E vs placebo
SPACE, 2000 - vitamin E vs placebo
WHS beta carotene, 1999 - beta carotene vs placebo
GISSI, 1999 - vitamin E vs control
NSCP (Green) beta carotene, 1999 - beta carotene vs placebo
ATBC 2nd prev subgroup (vitamin E), 1998 - vitamin E vs placebo
ATBC 2nd prev subgroup (b carotene), 1998 - beta carotene vs placebo
See also:
All cardiovascular prevention clinical trials
All clinical trials of antioxydants
All clinical trials of beta carotene
|
|
Treatments
Studied treatment |
beta carotene (Lurotin) 50 mg every two days
|
Control treatment |
placebo
|
Remarks |
2x2x2 factorial design testing the effects of ascorbic acid (500 mg/d), vitamin
E (600 IU every other day), and beta carotene (50 mg
every other day)
|
Patients
Patients |
female health professionals at increased risk (40 years or older with a history of CVD or 3 or more CVD risk factors) |
Inclusion criteria |
Women, aged 40 and over, at high risk, with a history of coronary artery disease, carotid endarterectomy, peripheral artery surgery, or three or more coronary heart disease risk factors |
Exclusion criteria |
self-reported history of cancer (excluding nonmelanoma skin cancer) within the past 10 years; any serious non-CVD illness; currently using warfarin sodium or other anticoagulants |
Baseline characteristics |
Women (%) |
100% |
age (yr) |
60.6 y |
Body mass index |
30.3 |
|
Method and design
Randomized effectives |
4084 / 4087 (studied vs. control) |
Design |
Factorial plan |
Blinding |
double blind |
Follow-up duration |
9.4 years |
Hypothesis |
Superiority |
Primary endpoint |
MI, stroke, coronary revascularization, CVD death |
Remarks |
|
Remarks / Comments
Results
Endpoints and data reported in the trial's publication(s)
Endpoint |
Events (%) |
Relative Risk |
95% CI |
|
Studied treat. |
Control treat. |
Major CVD (MI, stroke, revascularization procedure or death due to cardiovascular cause) |
731 / 4084 (17,9%) |
719 / 4087 (17,6%) |
1,02 |
[0,93;1,12] |
|
MI, stroke,CVD death |
435 / 4084 (10,7%) |
399 / 4087 (9,8%) |
1,09 |
[0,96;1,24] |
|
MI |
135 / 4084 (3,3%) |
139 / 4087 (3,4%) |
0,97 |
[0,77;1,23] |
|
Fatal MI |
10 / 4084 (0,2%) |
24 / 4087 (0,6%) |
0,42 |
[0,20;0,87] |
|
Nonfatal MI |
125 / 4084 (3,1%) |
115 / 4087 (2,8%) |
1,09 |
[0,85;1,40] |
|
Revascularization |
438 / 4084 (10,7%) |
451 / 4087 (11,0%) |
0,97 |
[0,86;1,10] |
|
Total CHD |
500 / 4084 (12,2%) |
499 / 4087 (12,2%) |
1,00 |
[0,89;1,13] |
|
Stroke |
161 / 4084 (3,9%) |
137 / 4087 (3,4%) |
1,18 |
[0,94;1,47] |
|
Ischemic stroke |
143 / 4084 (3,5%) |
128 / 4087 (3,1%) |
1,12 |
[0,88;1,41] |
|
Hemorrhagic stroke |
17 / 4084 (0,4%) |
8 / 4087 (0,2%) |
2,13 |
[0,92;4,92] |
|
Fatal stroke |
22 / 4084 (0,5%) |
11 / 4087 (0,3%) |
2,00 |
[0,97;4,12] |
|
Nonfatal stroke |
139 / 4084 (3,4%) |
126 / 4087 (3,1%) |
1,10 |
[0,87;1,40] |
|
TIA |
201 / 4084 (4,9%) |
220 / 4087 (5,4%) |
0,91 |
[0,76;1,10] |
|
CVD death |
211 / 4084 (5,2%) |
184 / 4087 (4,5%) |
1,15 |
[0,95;1,39] |
|
Total mortality |
505 / 4084 (12,4%) |
490 / 4087 (12,0%) |
1,03 |
[0,92;1,16] |
|
Endpoints used by the meta-analysis and data retained for this trial
Endpoint
Studied treat. n/N
Control treat. n/N
Graph
RR [95% CI]
Coronary event
135 / 4084
139 / 4087
0,97 [0,77;1,23]
Cardiovascular death
211 / 4084
184 / 4087
1,15 [0,95;1,39]
Non fatal MI
125 / 4084
115 / 4087
1,09 [0,85;1,40]
cardiovascular events
435 / 4084
399 / 4087
1,09 [0,96;1,24]
Haemmorhagic stroke
17 / 4084
8 / 4087
classic
2,13 [0,92;4,92]
All cause death
505 / 4084
490 / 4087
1,03 [0,92;1,16]
stroke (fatal and non fatal)
161 / 4084
137 / 4087
1,18 [0,94;1,47]
Non fatal stroke
139 / 4084
126 / 4087
1,10 [0,87;1,40]
ischemic stroke
143 / 4084
128 / 4087
1,12 [0,88;1,41]
0
2
1.0
Relative risks
|
Endpoint |
Events (%) |
Relative Risk |
95% CI |
Endpoint definition in the trial |
Ref |
Studied treat. |
Control treat. |
Coronary event
|
135 / 4084 (3,3%) |
139 / 4087 (3,4%) |
0,97 |
[0,77;1,23] |
MI |
|
Cardiovascular death
|
211 / 4084 (5,2%) |
184 / 4087 (4,5%) |
1,15 |
[0,95;1,39] |
CVD death |
0 |
Non fatal MI
|
125 / 4084 (3,1%) |
115 / 4087 (2,8%) |
1,09 |
[0,85;1,40] |
Nonfatal MI |
0 |
cardiovascular events
|
435 / 4084 (10,7%) |
399 / 4087 (9,8%) |
1,09 |
[0,96;1,24] |
MI, stroke,CVD death |
0 |
Haemmorhagic stroke
|
17 / 4084 (0,4%) |
8 / 4087 (0,2%) |
2,13 |
[0,92;4,92] |
Hemorrhagic stroke |
0 |
All cause death
|
505 / 4084 (12,4%) |
490 / 4087 (12,0%) |
1,03 |
[0,92;1,16] |
Total mortality |
0 |
stroke (fatal and non fatal)
|
161 / 4084 (3,9%) |
137 / 4087 (3,4%) |
1,18 |
[0,94;1,47] |
Stroke |
0 |
Non fatal stroke
|
139 / 4084 (3,4%) |
126 / 4087 (3,1%) |
1,10 |
[0,87;1,40] |
Nonfatal stroke |
0 |
ischemic stroke
|
143 / 4084 (3,5%) |
128 / 4087 (3,1%) |
1,12 |
[0,88;1,41] |
Ischemic stroke |
0 |
The primary endpoint (if exists) appears in blod characters
|
Reference(s) used for data extraction:
0:
|
Endpoint |
studied treat. |
control treat. |
mean diff |
Absolute risk reduction
|
Endpoint |
Events rate |
Absolute risk reduction (ARR) |
Studied treat. |
Control treat. |
Coronary event |
3,31% |
3,40% |
-1,0‰
|
Cardiovascular death |
5,17% |
4,50% |
6,6‰
|
Non fatal MI |
3,06% |
2,81% |
2,5‰
|
cardiovascular events |
10,65% |
9,76% |
8,9‰
|
Haemmorhagic stroke |
4,16‰ |
1,96‰ |
2,2‰
|
All cause death |
12,37% |
11,99% |
3,8‰
|
stroke (fatal and non fatal) |
3,94% |
3,35% |
5,9‰
|
Non fatal stroke |
3,40% |
3,08% |
3,2‰
|
ischemic stroke |
3,50% |
3,13% |
3,7‰
|
Meta-analysis of all similar trials:
antioxydants in cardiovascular prevention for secondary prevention
antioxydants in cardiovascular prevention for all type of patients
Reference(s)
-
Cook NR, Albert CM, Gaziano JM, Zaharris E, MacFadyen J, Danielson E, Buring JE, Manson JE.
A randomized factorial trial of vitamins C and E and beta carotene in the secondary prevention of cardiovascular events in women: results from the Women's Antioxidant Cardiovascular Study..
Arch Intern Med 2007 Aug 13-27;167:1610-8
Pubmed
|
Hubmed
| Fulltext
-
Bassuk SS, Albert CM, Cook NR, Zaharris E, MacFadyen JG, Danielson E, Van Denburgh M, Buring JE, Manson JE.
The Women's Antioxidant Cardiovascular Study: design and baseline characteristics of participants..
J Womens Health (Larchmt) 2004;13:99-117
- 10.1089/154099904322836519
Pubmed
|
Hubmed
| Fulltext
-
Manson JE, Gaziano JM, Spelsberg A, Ridker PM, Cook NR, Buring JE, Willett WC, Hennekens CH.
A secondary prevention trial of antioxidant vitamins and cardiovascular disease in women. Rationale, design, and methods. The WACS Research Group..
Ann Epidemiol 1995;5:261-9
Pubmed
|
Hubmed
| Fulltext
|