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 vitamin E
|
|
Treatments
Studied treatment |
vitamin E 400IU/d from natural sources
|
Control treatment |
matching placebo
|
Remarks |
factorial design of ramipril and vitamin E |
Patients
Patients |
women and men 55 years of age or older who were at high risk for cardiovascular events because they had cardiovascular disease or diabetes in addition to one other risk factor. |
Baseline characteristics |
|
Method and design
Randomized effectives |
4761 / 4780 (studied vs. control) |
Design |
Factorial plan |
Blinding |
double-blind |
Follow-up duration |
4.5y |
Premature discontinuation |
Premature discontinuation for futility |
Number of centre |
multicenter |
Geographic area |
Multinational: Canada, USA, Europe, South America |
Hypothesis |
Superiority |
Primary endpoint |
CV death, MI, stroke |
Results
Endpoint
Studied treat. n/N
Control treat. n/N
Graph
RR [95% CI]
Non fatal MI
532 / 4761
524 / 4780
1,02 [0,91;1,14]
Haemmorhagic stroke
17 / 4761
13 / 4780
classic
1,31 [0,64;2,70]
stroke (fatal and non fatal)
209 / 4761
180 / 4780
1,17 [0,96;1,42]
ischemic stroke
192 / 4761
167 / 4780
1,15 [0,94;1,41]
Cardiovascular death
342 / 4761
328 / 4780
1,05 [0,90;1,21]
cardiovascular events
772 / 4761
739 / 4780
1,05 [0,96;1,15]
Non fatal stroke
209 / 4761
180 / 4780
1,17 [0,96;1,42]
0
2
1.0
Relative risks
|
Endpoint |
Events (%) |
Relative Risk |
95% CI |
Endpoint definition in the trial |
Ref |
Studied treat. |
Control treat. |
stroke (fatal and non fatal)
|
209 / 4761 (4,4%) |
180 / 4780 (3,8%) |
1,17 |
[0,96;1,42] |
BMJ 2010 |
13777 |
ischemic stroke
|
192 / 4761 (4,0%) |
167 / 4780 (3,5%) |
1,15 |
[0,94;1,41] |
|
0 |
Cardiovascular death
|
342 / 4761 (7,2%) |
328 / 4780 (6,9%) |
1,05 |
[0,90;1,21] |
|
|
cardiovascular events
|
772 / 4761 (16,2%) |
739 / 4780 (15,5%) |
1,05 |
[0,96;1,15] |
|
|
Non fatal stroke
|
209 / 4761 (4,4%) |
180 / 4780 (3,8%) |
1,17 |
[0,96;1,42] |
|
|
Haemmorhagic stroke
|
17 / 4761 (0,4%) |
13 / 4780 (0,3%) |
1,31 |
[0,64;2,70] |
|
0 |
Non fatal MI
|
532 / 4761 (11,2%) |
524 / 4780 (11,0%) |
1,02 |
[0,91;1,14] |
|
|
The primary endpoint (if exists) appears in blod characters
|
Reference(s) used for data extraction:
13777: Sch�rks M, Glynn RJ, Rist PM, Tzourio C, Kurth TEffects of vitamin E on stroke subtypes: meta-analysis of randomised controlled trials.BMJ 2010 Nov 4;341:c5702
0:
|
Endpoint |
studied treat. |
control treat. |
mean diff |
Absolute risk reduction (for a follow-up of 4.5y)
|
Endpoint |
Events rate |
Absolute risk reduction (ARR) |
Studied treat. |
Control treat. |
stroke (fatal and non fatal) |
4,39% |
3,77% |
0,62%
|
ischemic stroke |
4,03% |
3,49% |
0,54%
|
Cardiovascular death |
7,18% |
6,86% |
0,32%
|
cardiovascular events |
16,22% |
15,46% |
0,75%
|
Non fatal stroke |
4,39% |
3,77% |
0,62%
|
Haemmorhagic stroke |
3,57‰ |
2,72‰ |
0,09%
|
Non fatal MI |
11,17% |
10,96% |
0,21%
|
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 |
TRC3707
|
Trials register # |
NA
|
-
Yusuf S, Dagenais G, Pogue J, Bosch J, Sleight P.
Vitamin E supplementation and cardiovascular events in high-risk patients. The Heart Outcomes Prevention Evaluation Study Investigators..
N Engl J Med 2000 Jan 20;342:154-60
Pubmed
|
Hubmed
| Fulltext
-
Lonn E, Bosch J, Yusuf S, Sheridan P, Pogue J, Arnold JM, Ross C, Arnold A, Sleight P, Probstfield J, Dagenais GR.
Effects of long-term vitamin E supplementation on cardiovascular events and cancer: a randomized controlled trial..
JAMA 2005 Mar 16;293:1338-47
Pubmed
|
Hubmed
| Fulltext
|