Related trials
WACS vitamin E, 2007 - vitamin E vs placebo
WACS vitamin C, 2007 - vitamin C vs placebo
WACS beta-caroten, 2007 - beta carotene vs placebo
HOPE renal insufficiency subgroup, 2004 - vitamin E vs placebo
Tepel, 2003 - acetylcysteine vs placebo
WAVE (Waters), 2002 - combination vs placebo
HPS antioxidant, 2002 - combination vs placebo
HATS, 2001 - combination vs placebo
HOPE, 2000 - vitamin E vs placebo
SPACE, 2000 - vitamin E vs placebo
GISSI, 1999 - vitamin E vs control
ATBC 2nd prev subgroup (vitamin E), 1998 - vitamin E vs placebo
ATBC 2nd prev subgroup (b carotene), 1998 - beta carotene vs placebo
MVP, 1997 - combination vs placebo
CHAOS, 1996 - vitamin E vs placebo
See also:
All cardiovascular prevention clinical trials
All clinical trials of antioxydants
All clinical trials of vitamin E
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Treatments
Studied treatment |
vitamin E 800 IU daily
|
Control treatment |
matching placebo
|
Patients
Patients |
Haemodialysis patients aged 40–75 years with pre-existing cardiovascular disease |
Baseline characteristics |
Women (%) |
31% |
age (yr) |
64.5y |
|
Method and design
Randomized effectives |
97 / 99 (studied vs. control) |
Design |
Parallel groups |
Blinding |
double -blind |
Follow-up duration |
1.42 years |
Number of centre |
6 |
Geographic area |
Israel |
Hypothesis |
Superiority |
Primary endpoint |
MI, stroke, PVD, unstable angina |
Results
Endpoint
Studied treat. n/N
Control treat. n/N
Graph
RR [95% CI]
Coronary event
8 / 97
18 / 99
0,45 [0,21;0,99]
Cardiovascular death
9 / 97
15 / 99
0,61 [0,28;1,33]
cardiovascular events
18 / 97
34 / 99
0,54 [0,33;0,89]
All cause death
31 / 97
29 / 99
1,09 [0,72;1,66]
stroke (fatal and non fatal)
5 / 97
6 / 99
classic
0,85 [0,27;2,70]
ischemic stroke
5 / 97
6 / 99
classic
0,85 [0,27;2,70]
0
2
1.0
Relative risks
|
Endpoint |
Events (%) |
Relative Risk |
95% CI |
Endpoint definition in the trial |
Ref |
Studied treat. |
Control treat. |
Coronary event
|
8 / 97 (8,2%) |
18 / 99 (18,2%) |
0,45 |
[0,21;0,99] |
MI including SD |
2948 |
Cardiovascular death
|
9 / 97 (9,3%) |
15 / 99 (15,2%) |
0,61 |
[0,28;1,33] |
|
2948 |
cardiovascular events
|
18 / 97 (18,6%) |
34 / 99 (34,3%) |
0,54 |
[0,33;0,89] |
including sudden death |
2948 |
All cause death
|
31 / 97 (32,0%) |
29 / 99 (29,3%) |
1,09 |
[0,72;1,66] |
|
2948 |
stroke (fatal and non fatal)
|
5 / 97 (5,2%) |
6 / 99 (6,1%) |
0,85 |
[0,27;2,70] |
|
2948 |
ischemic stroke
|
5 / 97 (5,2%) |
6 / 99 (6,1%) |
0,85 |
[0,27;2,70] |
BMJ 2010 |
13777 |
The primary endpoint (if exists) appears in blod characters
|
Reference(s) used for data extraction:
2948: Boaz M, Smetana S, Weinstein T, Matas Z, Gafter U, Iaina A, Knecht A, Weissgarten Y, Brunner D, Fainaru M, Green MSSecondary prevention with antioxidants of cardiovascular disease in endstage renal disease (SPACE): randomised placebo-controlled trial.Lancet 2000 Oct 7;356:1213-8
13777: Schürks 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
|
Endpoint |
Events rate |
Absolute risk reduction (ARR) |
Studied treat. |
Control treat. |
Coronary event |
8,25% |
18,18% |
-99,3‰
|
Cardiovascular death |
9,28% |
15,15% |
-58,7‰
|
cardiovascular events |
18,56% |
34,34% |
-157,9‰
|
All cause death |
31,96% |
29,29% |
2,7%
|
stroke (fatal and non fatal) |
5,15% |
6,06% |
-9,1‰
|
ischemic stroke |
5,15% |
6,06% |
-9,1‰
|
Meta-analysis of all similar trials:
antioxydants in cardiovascular prevention for patients with renal disease
antioxydants in cardiovascular prevention for secondary prevention
Reference(s)
-
Boaz M, Smetana S, Weinstein T, Matas Z, Gafter U, Iaina A, Knecht A, Weissgarten Y, Brunner D, Fainaru M, Green MS.
Secondary prevention with antioxidants of cardiovascular disease in endstage renal disease (SPACE): randomised placebo-controlled trial..
Lancet 2000 Oct 7;356:1213-8
Pubmed
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Hubmed
| Fulltext
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