Related trials
WACS vitamin C, 2007 - vitamin C vs placebo
WACS beta-caroten, 2007 - beta carotene vs placebo
WACS vitamin E, 2007 - vitamin E vs placebo
HOPE renal insufficiency subgroup, 2004 - vitamin E vs placebo
WAVE (Waters), 2002 - combination vs placebo
HPS antioxidant, 2002 - combination vs placebo
HATS, 2001 - combination vs placebo
SPACE, 2000 - vitamin E vs placebo
HOPE, 2000 - vitamin E vs placebo
GISSI, 1999 - vitamin E vs control
ATBC 2nd prev subgroup (b carotene), 1998 - beta carotene vs placebo
ATBC 2nd prev subgroup (vitamin E), 1998 - vitamin E 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 |
alpha tocopherol (vitamin E)
50 mg/day
synthetic DL alpha tocopheryl acetate
|
Control treatment |
placebo
|
Remarks |
factorial design of alpha tocopherol (vitamin E)
50 mg/day and beta carotene 20 mg/day |
Patients
Patients |
patients enroled in the ATBC trial and
who had angina pectoris in the Rose chest
pain questionnaire at baseline |
Inclusion criteria |
male smokers (five or more cigarettes daily); aged 50�69 years; angina pectoris in the Rose chest
pain questionnaire |
Exclusion criteria |
malignancy, severe angina pectoris
(angina when walking at normal pace on
the level), renal insufficiency, cirrhosis of the
liver, other medical problems limiting participation,
and use of anticoagulants or vitamin E,
vitamin A, or � carotene supplements |
Baseline characteristics |
Women (%) |
0% |
age (yr) |
58.8 y |
Body mass index |
26.5 |
|
Method and design
Randomized effectives |
916 / 879 (studied vs. control) |
Design |
Factorial plan |
Blinding |
double-blind |
Follow-up duration |
3.79 y |
Number of centre |
multicenter |
Geographic area |
Finland |
Hypothesis |
Superiority |
Primary endpoint |
not defined |
Results
Endpoint
Studied treat. n/N
Control treat. n/N
Graph
RR [95% CI]
Coronary event
155 / 916
159 / 879
0,94 [0,77;1,14]
Coronary death
88 / 916
80 / 879
1,06 [0,79;1,41]
Non fatal MI
67 / 916
79 / 879
0,81 [0,60;1,11]
0
2
1.0
Relative risks
|
Endpoint |
Events (%) |
Relative Risk |
95% CI |
Endpoint definition in the trial |
Ref |
Studied treat. |
Control treat. |
Coronary death
|
88 / 916 (9,6%) |
80 / 879 (9,1%) |
1,06 |
[0,79;1,41] |
|
13140 |
Coronary event
|
155 / 916 (16,9%) |
159 / 879 (18,1%) |
0,94 |
[0,77;1,14] |
|
13140 |
Non fatal MI
|
67 / 916 (7,3%) |
79 / 879 (9,0%) |
0,81 |
[0,60;1,11] |
|
13140 |
The primary endpoint (if exists) appears in blod characters
|
Reference(s) used for data extraction:
0:
13140: Rapola JM, Virtamo J, Ripatti S, Haukka JK, Huttunen JK, Albanes D, Taylor PR, Heinonen OPEffects of alpha tocopherol and beta carotene supplements on symptoms, progression, and prognosis of angina pectoris.Heart 1998;79:454-8
|
Endpoint |
studied treat. |
control treat. |
mean diff |
Absolute risk reduction
|
Endpoint |
Events rate |
Absolute risk reduction (ARR) |
Studied treat. |
Control treat. |
Coronary death |
9,61% |
9,10% |
5,1‰
|
Coronary event |
16,92% |
18,09% |
-11,7‰
|
Non fatal MI |
7,31% |
8,99% |
-16,7‰
|
Meta-analysis of all similar trials:
antioxydants in cardiovascular prevention for secondary prevention
Reference(s)
-
Rapola JM, Virtamo J, Ripatti S, Haukka JK, Huttunen JK, Albanes D, Taylor PR, Heinonen OP.
Effects of alpha tocopherol and beta carotene supplements on symptoms, progression, and prognosis of angina pectoris..
Heart 1998;79:454-8
Pubmed
|
Hubmed
| Fulltext
-
Rapola JM, Virtamo J, Ripatti S, Huttunen JK, Albanes D, Taylor PR, Heinonen OP.
Randomised trial of alpha-tocopherol and beta-carotene supplements on incidence of major coronary events in men with previous myocardial infarction..
Lancet 1997;349:1715-20
- 10.1016/S0140-6736(97)01234-8
Pubmed
|
Hubmed
| Fulltext
|