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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
    		•  

    PHS II vitamin E study, 2008

    [NCT00270647] download pdf: vitamin E | antioxydants for cardiovascular prevention

    Treatments

    Studied treatment vitamin E 400IU every two days
    Control treatment placebo
    Remarks factorial trial evaluating vitamin E (400 IU every 2 days synthetic alpha-tocopherol), vitaminC(500mg synthetic ascorbic acid), a multivitamin (Centrum Silver daily; Wyeth Pharmaceuticals) and beta carotene (50mg, Lurotin on alternate days)

    Patients

    Patients US male physicians aged 50 years or older
    Inclusion criteria men with a history of myocardial infarction (MI), stroke, or cancer were eligible
    Exclusion criteria history of cirrhosis; active liver disease; anticoagulants; serious illness that might preclude participation
    Remarks 7641 partcipant from PHS I and 7000 new physicians
    Baseline characteristics
    Women (%) 0% 
    age (yr) 64.3 y 
    Body mass index 26 

    Method and design

    Randomized effectives 7315 / 7326 (studied vs. control)
    Blinding double blind
    Follow-up duration 8 years (mean)
    Number of centre postal survey
    Geographic area US
    Hypothesis Superiority
    Primary endpoint Cv death, MI, Stroke
    Remarks

    Remarks / Comments



    Results



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

    Endpoint Events (%) Relative Risk 95% CI
    Studied treat. Control treat.
    CV death, MI, stroke 620 / 7315 (8,5%) 625 / 7326 (8,5%) 0,99 [0,89;1,10]
    fatal and non fatal myocardial infarction 240 / 7315 (3,3%) 271 / 7326 (3,7%) 0,89 [0,75;1,05]
    Myocardial infarction death 22 / 7315 (0,3%) 30 / 7326 (0,4%) 0,73 [0,42;1,27]
    fatal and non fatal stroke 237 / 7315 (3,2%) 227 / 7326 (3,1%) 1,05 [0,87;1,25]
    Stroke death 45 / 7315 (0,6%) 56 / 7326 (0,8%) 0,80 [0,54;1,19]
    Ischemic stroke 191 / 7315 (2,6%) 196 / 7326 (2,7%) 0,98 [0,80;1,19]
    Hemorrhagic stroke 39 / 7315 (0,5%) 23 / 7326 (0,3%) 1,70 [1,02;2,84]
    Cardiovascular death 258 / 7315 (3,5%) 251 / 7326 (3,4%) 1,03 [0,87;1,22]
    Congestive heart failure 289 / 7315 (4,0%) 294 / 7326 (4,0%) 0,98 [0,84;1,15]
    Angina 718 / 7315 (9,8%) 765 / 7326 (10,4%) 0,94 [0,85;1,04]
    Revascularization 675 / 7315 (9,2%) 709 / 7326 (9,7%) 0,95 [0,86;1,05]
    Total mortality 841 / 7315 (11,5%) 820 / 7326 (11,2%) 1,03 [0,94;1,12]

    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]

    Cardiovascular death

    258 / 7315
         251 / 7326
         1,03 [0,87;1,22]

    cardiovascular events

    620 / 7315
         625 / 7326
         0,99 [0,89;1,10]

    Haemmorhagic stroke

    39 / 7315
         23 / 7326
         classic 1,70 [1,02;2,84]

    All cause death

    841 / 7315
         820 / 7326
         1,03 [0,94;1,12]

    stroke (fatal and non fatal)

    237 / 7315
         227 / 7326
         1,05 [0,87;1,25]

    ischemic stroke

    191 / 7315
         196 / 7326
         0,98 [0,80;1,19]     0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial    		 Ref
    Studied treat. Control treat.
    Cardiovascular death 258 / 7315 (3,5%) 251 / 7326 (3,4%) 1,03 [0,87;1,22] Cardiovascular death  0
    cardiovascular events 620 / 7315 (8,5%) 625 / 7326 (8,5%) 0,99 [0,89;1,10] CV death, MI, stroke  0
    Haemmorhagic stroke 39 / 7315 (0,5%) 23 / 7326 (0,3%) 1,70 [1,02;2,84] Hemorrhagic stroke  0
    All cause death 841 / 7315 (11,5%) 820 / 7326 (11,2%) 1,03 [0,94;1,12] Total mortality  0
    stroke (fatal and non fatal) 237 / 7315 (3,2%) 227 / 7326 (3,1%) 1,05 [0,87;1,25] fatal and non fatal stroke  0
    ischemic stroke 191 / 7315 (2,6%) 196 / 7326 (2,7%) 0,98 [0,80;1,19] 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.
    Cardiovascular death 3,53% 3,43% 1,0‰
    cardiovascular events 8,48% 8,53% -0,6‰
    Haemmorhagic stroke 5,33‰ 3,14‰ 2,2‰
    All cause death 11,50% 11,19% 3,0‰
    stroke (fatal and non fatal) 3,24% 3,10% 1,4‰
    ischemic stroke 2,61% 2,68% -0,6‰

    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 # NCT00270647
    • Sesso HD, Buring JE, Christen WG, Kurth T, Belanger C, MacFadyen J, Bubes V, Manson JE, Glynn RJ, Gaziano JM. Vitamins E and C in the prevention of cardiovascular disease in men: the Physicians' Health Study II randomized controlled trial.. JAMA 2008 Nov 12;300:2123-33
      Pubmed | Hubmed | Fulltext

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