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Systematic review and meta-analysis

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

cardiovascular prevention - antioxydants - secondary prevention

cardiovascular prevention - antioxydants - all type of patients


Related trials

PHS II vitamin C, 2008 - vitamin C vs placebo

POPADAD (antioxydant), 2008 - combination vs placebo

ARISE, 2008 - succinobucol vs placebo

PHS II vitamin E, 2008 - vitamin E 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

WHS vitamin E, 2005 - vitamin E vs placebo

SUVIMAX, 2005 - combination 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

HATS, 2001 - combination vs placebo

PPP, 2001 - vitamin E vs control

AREDS, 2001 - vitamin E vs placebo

HOPE, 2000 - vitamin E vs placebo

ASAP, 2000 - vitamin E vs placebo

SPACE, 2000 - vitamin E vs placebo

WHS beta carotene, 1999 - beta carotene vs placebo

GISSI, 1999 - vitamin E vs control

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

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

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 beta carotene
    		•  

    WACS beta-caroten study, 2007

    [NCT00000541] download pdf: beta carotene | antioxydants for cardiovascular prevention

    Treatments

    Studied treatment beta carotene (Lurotin) 50 mg 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 other day)

    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 4084 / 4087 (studied vs. control)
    Design Factorial plan
    Blinding double blind
    Follow-up duration 9.4 years
    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 CVD (MI, stroke, revascularization procedure or death due to cardiovascular cause) 731 / 4084 (17,9%) 719 / 4087 (17,6%) 1,02 [0,93;1,12]
    MI, stroke,CVD death 435 / 4084 (10,7%) 399 / 4087 (9,8%) 1,09 [0,96;1,24]
    MI 135 / 4084 (3,3%) 139 / 4087 (3,4%) 0,97 [0,77;1,23]
    Fatal MI 10 / 4084 (0,2%) 24 / 4087 (0,6%) 0,42 [0,20;0,87]
    Nonfatal MI 125 / 4084 (3,1%) 115 / 4087 (2,8%) 1,09 [0,85;1,40]
    Revascularization 438 / 4084 (10,7%) 451 / 4087 (11,0%) 0,97 [0,86;1,10]
    Total CHD 500 / 4084 (12,2%) 499 / 4087 (12,2%) 1,00 [0,89;1,13]
    Stroke 161 / 4084 (3,9%) 137 / 4087 (3,4%) 1,18 [0,94;1,47]
    Ischemic stroke 143 / 4084 (3,5%) 128 / 4087 (3,1%) 1,12 [0,88;1,41]
    Hemorrhagic stroke 17 / 4084 (0,4%) 8 / 4087 (0,2%) 2,13 [0,92;4,92]
    Fatal stroke 22 / 4084 (0,5%) 11 / 4087 (0,3%) 2,00 [0,97;4,12]
    Nonfatal stroke 139 / 4084 (3,4%) 126 / 4087 (3,1%) 1,10 [0,87;1,40]
    TIA 201 / 4084 (4,9%) 220 / 4087 (5,4%) 0,91 [0,76;1,10]
    CVD death 211 / 4084 (5,2%) 184 / 4087 (4,5%) 1,15 [0,95;1,39]
    Total mortality 505 / 4084 (12,4%) 490 / 4087 (12,0%) 1,03 [0,92;1,16]

    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

    135 / 4084
         139 / 4087
         0,97 [0,77;1,23]

    Cardiovascular death

    211 / 4084
         184 / 4087
         1,15 [0,95;1,39]

    Non fatal MI

    125 / 4084
         115 / 4087
         1,09 [0,85;1,40]

    cardiovascular events

    435 / 4084
         399 / 4087
         1,09 [0,96;1,24]

    Haemmorhagic stroke

    17 / 4084
         8 / 4087
         classic 2,13 [0,92;4,92]

    All cause death

    505 / 4084
         490 / 4087
         1,03 [0,92;1,16]

    stroke (fatal and non fatal)

    161 / 4084
         137 / 4087
         1,18 [0,94;1,47]

    Non fatal stroke

    139 / 4084
         126 / 4087
         1,10 [0,87;1,40]

    ischemic stroke

    143 / 4084
         128 / 4087
         1,12 [0,88;1,41]     0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial    		 Ref
    Studied treat. Control treat.
    Coronary event 135 / 4084 (3,3%) 139 / 4087 (3,4%) 0,97 [0,77;1,23] MI 
    Cardiovascular death 211 / 4084 (5,2%) 184 / 4087 (4,5%) 1,15 [0,95;1,39] CVD death  0
    Non fatal MI 125 / 4084 (3,1%) 115 / 4087 (2,8%) 1,09 [0,85;1,40] Nonfatal MI  0
    cardiovascular events 435 / 4084 (10,7%) 399 / 4087 (9,8%) 1,09 [0,96;1,24] MI, stroke,CVD death   0
    Haemmorhagic stroke 17 / 4084 (0,4%) 8 / 4087 (0,2%) 2,13 [0,92;4,92] Hemorrhagic stroke  0
    All cause death 505 / 4084 (12,4%) 490 / 4087 (12,0%) 1,03 [0,92;1,16] Total mortality  0
    stroke (fatal and non fatal) 161 / 4084 (3,9%) 137 / 4087 (3,4%) 1,18 [0,94;1,47] Stroke  0
    Non fatal stroke 139 / 4084 (3,4%) 126 / 4087 (3,1%) 1,10 [0,87;1,40] Nonfatal stroke  0
    ischemic stroke 143 / 4084 (3,5%) 128 / 4087 (3,1%) 1,12 [0,88;1,41] 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 3,31% 3,40% -1,0‰
    Cardiovascular death 5,17% 4,50% 6,6‰
    Non fatal MI 3,06% 2,81% 2,5‰
    cardiovascular events 10,65% 9,76% 8,9‰
    Haemmorhagic stroke 4,16‰ 1,96‰ 2,2‰
    All cause death 12,37% 11,99% 3,8‰
    stroke (fatal and non fatal) 3,94% 3,35% 5,9‰
    Non fatal stroke 3,40% 3,08% 3,2‰
    ischemic stroke 3,50% 3,13% 3,7‰

    Meta-analysis of all similar trials:

    antioxydants in cardiovascular prevention for secondary prevention

    antioxydants in cardiovascular prevention for all type of patients



    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 Aug 13-27;167:1610-8
      Pubmed | Hubmed | Fulltext
    • Bassuk SS, Albert CM, Cook NR, Zaharris E, MacFadyen JG, Danielson E, Van Denburgh M, Buring JE, Manson JE. The Women's Antioxidant Cardiovascular Study: design and baseline characteristics of participants.. J Womens Health (Larchmt) 2004;13:99-117 - 10.1089/154099904322836519
      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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