Related trials
PHS II (multivitamin), 2012 - combination vs placebo
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
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
PPP, 2001 - vitamin E vs control
AREDS, 2001 - vitamin E vs placebo
HATS, 2001 - combination vs placebo
SPACE, 2000 - vitamin E 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
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 combination
|
|
Treatments
Studied treatment |
antioxidant vitamin
supplementation (600 mg vitamin E, 250 mg vitamin C, and
20 mg -carotene daily)
|
Control treatment |
matching placebo
|
Remarks |
factorial design with cholesterol lowering therapy |
Patients
Patients |
UK adults (aged 40–80) with coronary disease, other occlusive arterial disease, or diabetes |
Inclusion criteria |
Men and women; aged about 40 years to 80 years; non-fasting blood total cholesterol concentrations of at least 3·5 mmol/L; substantial 5-year risk of death from coronary heart disease because of a past medical history of coronary heart disease, of other occlusive arterial disease, of diabetes mellitus, or of treated hypertension alone |
Exclusion criteria |
life-threatening conditions, such as chronic liver disease, severe renal disease, severe heart failure, severe chronic airways disease, or diagnosed cancer (other than non-melanoma skin cancer); high-dose vitamin E supplements |
Method and design
Randomized effectives |
10269 / 10267 (studied vs. control) |
Design |
Factorial plan |
Blinding |
double-blind |
Follow-up duration |
jul 1994 - may 1997 |
Number of centre |
69 |
Geographic area |
UK |
Hypothesis |
Superiority |
Primary endpoint |
coronary events |
Results
Endpoint
Studied treat. n/N
Control treat. n/N
Graph
RR [95% CI]
Coronary event
1063 / 10269
1047 / 10267
1,02 [0,94;1,10]
stroke (fatal and non fatal)
511 / 10269
518 / 10267
0,99 [0,88;1,11]
Cardiovascular death
878 / 10269
840 / 10267
1,05 [0,95;1,14]
cardiovascular events
2306 / 10269
2312 / 10267
1,00 [0,95;1,05]
All cause death
1446 / 10269
1389 / 10267
1,04 [0,97;1,11]
Non fatal stroke
430 / 10269
435 / 10267
0,99 [0,87;1,13]
Non fatal MI
464 / 10269
467 / 10267
0,99 [0,88;1,13]
0
2
1.0
Relative risks
|
Endpoint |
Events (%) |
Relative Risk |
95% CI |
Endpoint definition in the trial |
Ref |
Studied treat. |
Control treat. |
Coronary event
|
1063 / 10269 (10,4%) |
1047 / 10267 (10,2%) |
1,02 |
[0,94;1,10] |
|
2942 |
stroke (fatal and non fatal)
|
511 / 10269 (5,0%) |
518 / 10267 (5,0%) |
0,99 |
[0,88;1,11] |
|
2942 |
Cardiovascular death
|
878 / 10269 (8,6%) |
840 / 10267 (8,2%) |
1,05 |
[0,95;1,14] |
|
2942 |
cardiovascular events
|
2306 / 10269 (22,5%) |
2312 / 10267 (22,5%) |
1,00 |
[0,95;1,05] |
fig 3 |
2942 |
All cause death
|
1446 / 10269 (14,1%) |
1389 / 10267 (13,5%) |
1,04 |
[0,97;1,11] |
|
2942 |
Non fatal stroke
|
430 / 10269 (4,2%) |
435 / 10267 (4,2%) |
0,99 |
[0,87;1,13] |
|
2942 |
Non fatal MI
|
464 / 10269 (4,5%) |
467 / 10267 (4,5%) |
0,99 |
[0,88;1,13] |
|
2942 |
The primary endpoint (if exists) appears in blod characters
|
Reference(s) used for data extraction:
2942: MRC/BHF Heart Protection Study of antioxidant vitamin supplementation in 20,536 high-risk individuals: a randomised placebo-controlled trial.Lancet 2002 Jul 6;360:23-33
0:
|
Endpoint |
studied treat. |
control treat. |
mean diff |
Absolute risk reduction (for a follow-up of jul 1994 - may 1997)
|
Endpoint |
Events rate |
Absolute risk reduction (ARR) |
Studied treat. |
Control treat. |
Coronary event |
10,35% |
10,20% |
0,15%
|
stroke (fatal and non fatal) |
4,98% |
5,05% |
-0,07%
|
Cardiovascular death |
8,55% |
8,18% |
0,37%
|
cardiovascular events |
22,46% |
22,52% |
-0,06%
|
All cause death |
14,08% |
13,53% |
0,55%
|
Non fatal stroke |
4,19% |
4,24% |
-0,05%
|
Non fatal MI |
4,52% |
4,55% |
-0,03%
|
Meta-analysis of all similar trials:
antioxydants in cardiovascular prevention for all type of patients
antioxydants in cardiovascular prevention for secondary prevention
Reference(s)
TrialResults-center ID |
TRC3698
|
Trials register # |
NA
|
-
.
MRC/BHF Heart Protection Study of antioxidant vitamin supplementation in 20,536 high-risk individuals: a randomised placebo-controlled trial..
Lancet 2002 Jul 6;360:23-33
Pubmed
|
Hubmed
| Fulltext
|