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Systematic review and meta-analysis

This trial is included in the following systematic reviews and meta-analyses:

cardiovascular prevention - antioxydants - all type of patients

cardiovascular prevention - antioxydants - secondary prevention


Related trials

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 beta-caroten, 2007 - beta carotene vs placebo

WACS vitamin E, 2007 - vitamin E vs placebo

WACS vitamin C, 2007 - vitamin C 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

HPS antioxidant, 2002 - combination vs placebo

WAVE (Waters), 2002 - combination vs placebo

HATS, 2001 - combination vs placebo

PPP, 2001 - vitamin E vs control

AREDS, 2001 - vitamin E vs placebo

ASAP, 2000 - vitamin E vs placebo

SPACE, 2000 - vitamin E vs placebo

HOPE, 2000 - vitamin E vs placebo

GISSI, 1999 - vitamin E vs control

NSCP (Green) beta carotene, 1999 - beta carotene vs placebo

WHS beta carotene, 1999 - beta carotene vs placebo

ATBC 2nd prev subgroup (b carotene), 1998 - beta carotene vs placebo

ATBC 2nd prev subgroup (vitamin E), 1998 - vitamin E vs placebo



See also:

  • All cardiovascular prevention clinical trials
  • All clinical trials of antioxydants
  • All clinical trials of vitamin E
    		•  

    WACS vitamin E study, 2007

    [NCT00000541] download pdf: vitamin E | antioxydants for cardiovascular prevention

    Treatments

    Studied treatment vitamin E (600IU 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 2day)

    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 4083 / 4088 (studied vs. control)
    Design Factorial plan
    Blinding double blind
    Follow-up duration 9.4 years
    Geographic area US
    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 cardiovascular disease (MI, stroke, revascularization, cardiovascular death) 708 / 4083 (17,3%) 742 / 4088 (18,2%) 0,96 [0,87;1,05]
    MI, stroke,CVD death 399 / 4083 (9,8%) 435 / 4088 (10,6%) 0,92 [0,81;1,04]
    MI 131 / 4083 (3,2%) 143 / 4088 (3,5%) 0,92 [0,73;1,16]
    Fatal MI 18 / 4083 (0,4%) 16 / 4088 (0,4%) 1,13 [0,58;2,21]
    Nonfatal MI 113 / 4083 (2,8%) 127 / 4088 (3,1%) 0,89 [0,69;1,14]
    Revascularization 438 / 4083 (10,7%) 451 / 4088 (11,0%) 0,97 [0,86;1,10]
    Total CHD (MI, revascularization, and CHD death) 491 / 4083 (12,0%) 508 / 4088 (12,4%) 0,97 [0,86;1,09]
    Stroke 137 / 4083 (3,4%) 161 / 4088 (3,9%) 0,85 [0,68;1,07]
    Ischemic Stroke 121 / 4083 (3,0%) 150 / 4088 (3,7%) 0,81 [0,64;1,02]
    Hemorrhagic Stroke 15 / 4083 (0,4%) 10 / 4088 (0,2%) 1,50 [0,68;3,34]
    Fatal Stroke 18 / 4083 (0,4%) 15 / 4088 (0,4%) 1,20 [0,61;2,38]
    Nonfatal Stroke 119 / 4083 (2,9%) 146 / 4088 (3,6%) 0,82 [0,64;1,04]
    TIA 205 / 4083 (5,0%) 216 / 4088 (5,3%) 0,95 [0,79;1,14]
    CVD death 193 / 4083 (4,7%) 202 / 4088 (4,9%) 0,96 [0,79;1,16]
    Total mortality 502 / 4083 (12,3%) 493 / 4088 (12,1%) 1,02 [0,91;1,15]

    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

    131 / 4083
         143 / 4088
         0,92 [0,73;1,16]

    Cardiovascular death

    193 / 4083
         202 / 4088
         0,96 [0,79;1,16]

    Non fatal MI

    113 / 4083
         127 / 4088
         0,89 [0,69;1,14]

    cardiovascular events

    399 / 4083
         435 / 4088
         0,92 [0,81;1,04]

    Haemmorhagic stroke

    15 / 4083
         10 / 4088
         classic 1,50 [0,68;3,34]

    All cause death

    502 / 4083
         493 / 4088
         1,02 [0,91;1,15]

    stroke (fatal and non fatal)

    137 / 4083
         161 / 4088
         0,85 [0,68;1,07]

    Non fatal stroke

    119 / 4083
         146 / 4088
         0,82 [0,64;1,04]

    ischemic stroke

    121 / 4083
         150 / 4088
         0,81 [0,64;1,02]     0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial    		 Ref
    Studied treat. Control treat.
    Coronary event 131 / 4083 (3,2%) 143 / 4088 (3,5%) 0,92 [0,73;1,16] MI 
    Cardiovascular death 193 / 4083 (4,7%) 202 / 4088 (4,9%) 0,96 [0,79;1,16] CVD death  0
    Non fatal MI 113 / 4083 (2,8%) 127 / 4088 (3,1%) 0,89 [0,69;1,14] Nonfatal MI  0
    cardiovascular events 399 / 4083 (9,8%) 435 / 4088 (10,6%) 0,92 [0,81;1,04] MI, stroke,CVD death  0
    Haemmorhagic stroke 15 / 4083 (0,4%) 10 / 4088 (0,2%) 1,50 [0,68;3,34] Hemorrhagic Stroke  0
    All cause death 502 / 4083 (12,3%) 493 / 4088 (12,1%) 1,02 [0,91;1,15] Total mortality  0
    stroke (fatal and non fatal) 137 / 4083 (3,4%) 161 / 4088 (3,9%) 0,85 [0,68;1,07] Stroke  0
    Non fatal stroke 119 / 4083 (2,9%) 146 / 4088 (3,6%) 0,82 [0,64;1,04] Nonfatal Stroke  0
    ischemic stroke 121 / 4083 (3,0%) 150 / 4088 (3,7%) 0,81 [0,64;1,02] 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 3,21% 3,50% -2,9‰
    Cardiovascular death 4,73% 4,94% -2,1‰
    Non fatal MI 2,77% 3,11% -3,4‰
    cardiovascular events 9,77% 10,64% -8,7‰
    Haemmorhagic stroke 3,67‰ 2,45‰ 1,2‰
    All cause death 12,29% 12,06% 2,4‰
    stroke (fatal and non fatal) 3,36% 3,94% -5,8‰
    Non fatal stroke 2,91% 3,57% -6,6‰
    ischemic stroke 2,96% 3,67% -7,1‰

    Meta-analysis of all similar trials:

    antioxydants in cardiovascular prevention for all type of patients

    antioxydants in cardiovascular prevention for secondary prevention



    Reference(s)

    Trials register # NCT00000541
    • 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;167:1610-8
      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

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