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Systematic review and meta-analysis

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

cardiovascular prevention - antioxydants - primary 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

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

WHS beta carotene, 1999 - beta carotene vs placebo

GISSI, 1999 - vitamin E vs control

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

MVP, 1997 - combination vs placebo

PHS beta carotene, 1996 - beta carotene vs placebo

CARET beta carotene, 1996 - beta carotene 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
    		•  

    WHS vitamin E study, 2005

    [NCT00000479] download pdf: vitamin E | antioxydants for cardiovascular prevention

    Treatments

    Studied treatment vitamin E 600 IU every other day (á-tocopherol)
    Control treatment placebo
    Remarks factorial design vitamin E or placebo and aspirin or placebo

    Patients

    Patients apparently healthy US women aged at least 45 years
    Inclusion criteria age 45 years or older; no previous history of coronary heart disease, cerebrovascular disease, cancer (except nonmelanoma skin cancer), or other major chronic illnesses; no history of adverse effects from aspirin; no use of aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) more than once a week, or willingness to forgo their use; no use of anticoagulants or corticosteroids; and no use of individual supplements of vitamin A, E, or beta carotene more than once a week
    Baseline characteristics
    Women (%) 100% 
    age (yr) 54.6 y 
    Body mass index 26.04 

    Method and design

    Randomized effectives 19937 / 19939 (studied vs. control)
    Design Factorial plan
    Blinding double-blind
    Follow-up duration 10.1 y
    Lost to follow-up 2.8% (morbidity)
    Geographic area US
    Hypothesis Superiority
    Primary endpoint major cardiovascular event
    Remarks two primary endpoint specified without method for dealing with multiplicity


    Results



    Endpoints and data reported in the trial's publication(s)

    Endpoint Events (%) Relative Risk 95% CI
    Studied treat. Control treat.
    Major cardiovascular event* 482 / 19937 (2,4%) 517 / 19939 (2,6%) 0,93 [0,82;1,05]
    Myocardial infarction 196 / 19937 (1,0%) 195 / 19939 (1,0%) 1,01 [0,83;1,22]
    Nonfatal 184 / 19937 (0,9%) 181 / 19939 (0,9%) 1,02 [0,83;1,25]
    Fatal 12 / 19937 (0,1%) 14 / 19939 (0,1%) 0,86 [0,40;1,85]
    Stroke 241 / 19937 (1,2%) 246 / 19939 (1,2%) 0,98 [0,82;1,17]
    Nonfatal stroke 220 / 19937 (1,1%) 222 / 19939 (1,1%) 0,99 [0,82;1,19]
    Fatal stroke 21 / 19937 (0,1%) 24 / 19939 (0,1%) 0,88 [0,49;1,57]
    Ischemic stroke 194 / 19937 (1,0%) 197 / 19939 (1,0%) 0,98 [0,81;1,20]
    Hemorrhagic stroke 44 / 19937 (0,2%) 48 / 19939 (0,2%) 0,92 [0,61;1,38]
    Cardiovascular death 106 / 19937 (0,5%) 140 / 19939 (0,7%) 0,76 [0,59;0,97]
    Total invasive cancer 1437 / 19937 (7,2%) 1428 / 19939 (7,2%) 1,01 [0,94;1,08]
    Breast cancer 616 / 19937 (3,1%) 614 / 19939 (3,1%) 1,00 [0,90;1,12]
    Lung cancer 107 / 19937 (0,5%) 98 / 19939 (0,5%) 1,09 [0,83;1,44]
    Colon cancer 107 / 19937 (0,5%) 107 / 19939 (0,5%) 1,00 [0,77;1,31]
    Cancer death 308 / 19937 (1,5%) 275 / 19939 (1,4%) 1,12 [0,95;1,32]
    Total mortality 636 / 19937 (3,2%) 615 / 19939 (3,1%) 1,03 [0,93;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]

    ischemic stroke

    194 / 19937
         197 / 19939
         0,98 [0,81;1,20]

    stroke (fatal and non fatal)

    241 / 19937
         246 / 19939
         0,98 [0,82;1,17]

    Haemmorhagic stroke

    44 / 19937
         48 / 19939
         0,92 [0,61;1,38]     0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial    		 Ref
    Studied treat. Control treat.
    Haemmorhagic stroke 44 / 19937 (0,2%) 48 / 19939 (0,2%) 0,92 [0,61;1,38]   13777
    stroke (fatal and non fatal) 241 / 19937 (1,2%) 246 / 19939 (1,2%) 0,98 [0,82;1,17] BMJ 2010  13777
    ischemic stroke 194 / 19937 (1,0%) 197 / 19939 (1,0%) 0,98 [0,81;1,20] BMJ 2010  13777
    The primary endpoint (if exists) appears in blod characters
    Reference(s) used for data extraction:
  • 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

    • Endpoint studied treat. control treat. mean diff

    Absolute risk reduction
    Endpoint Events rate Absolute risk
    reduction (ARR)
    Studied treat. Control treat.
    Haemmorhagic stroke 2,21‰ 2,41‰ -0,2‰
    stroke (fatal and non fatal) 1,21% 1,23% -0,2‰
    ischemic stroke 9,73‰ 9,88‰ -0,1‰

    Meta-analysis of all similar trials:

    antioxydants in cardiovascular prevention for primary prevention

    antioxydants in cardiovascular prevention for all type of patients



    Reference(s)

    Trials register # NCT00000479
    • Lee IM, Cook NR, Gaziano JM, Gordon D, Ridker PM, Manson JE, Hennekens CH, Buring JE. Vitamin E in the primary prevention of cardiovascular disease and cancer: the Women's Health Study: a randomized controlled trial.. JAMA 2005;294:56-65 - 10.1001/jama.294.1.56
      Pubmed | Hubmed | Fulltext

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