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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 - primary prevention


Related trials

PHS II (multivitamin), 2012 - combination vs placebo

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 vitamin E, 2007 - vitamin E vs placebo

WACS vitamin C, 2007 - vitamin C vs placebo

WACS beta-caroten, 2007 - beta carotene vs placebo

SUVIMAX, 2005 - combination vs placebo

WHS vitamin E, 2005 - 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

PPP, 2001 - vitamin E vs control

AREDS, 2001 - vitamin E vs placebo

HATS, 2001 - combination vs placebo

ASAP, 2000 - vitamin E vs placebo

HOPE, 2000 - vitamin E vs placebo

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

WHS beta carotene, 1999 - beta carotene vs placebo

GISSI, 1999 - vitamin E vs control

MVP, 1997 - combination vs placebo

PHS beta carotene, 1996 - beta carotene vs placebo

CARET beta carotene, 1996 - beta carotene vs placebo



See also:

  • All cardiovascular prevention clinical trials
  • All clinical trials of antioxydants
  • All clinical trials of vitamin C
    		•  
     PHS II vitamin C study, 2008 TRC8811 
    [NCT00270647] download pdf: vitamin C | antioxydants for cardiovascular prevention

    Treatments

    Studied treatment vitamin C 500mg daily
    Control treatment placebo
    Remarks 2x2x2x2 factorial trial evaluating vitamin E (400 IU 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
    Baseline characteristics
    Women (%) 0% 
    age (yr) 64.3 y 
    Body mass index 26 

    Method and design

    Randomized effectives 7329 / 7312 (studied vs. control)
    Design Factorial plan
    Blinding double blind
    Follow-up duration 8 years (mean)
    Lost to follow-up 4.7% (morbidity)
    Number of centre postal survey
    Geographic area US
    Hypothesis Superiority
    Primary endpoint Cv death, MI, Stroke


    Results



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

    Endpoint Events (%) Relative Risk 95% CI
    Studied treat. Control treat.
    cardiovascular events (nonfatal myocardial infarction, nonfatal stroke, and cardiovascular death) 619 / 7329 (8,4%) 626 / 7312 (8,6%) 0,99 [0,89;1,10]
    fatal and non fatal MI 260 / 7329 (3,5%) 251 / 7312 (3,4%) 1,03 [0,87;1,23]
    Myocardial infarction death 30 / 7329 (0,4%) 22 / 7312 (0,3%) 1,36 [0,79;2,36]
    fatal and non fatal stroke 218 / 7329 (3,0%) 246 / 7312 (3,4%) 0,88 [0,74;1,06]
    Stroke death 44 / 7329 (0,6%) 57 / 7312 (0,8%) 0,77 [0,52;1,14]
    Ischemic stroke 180 / 7329 (2,5%) 207 / 7312 (2,8%) 0,87 [0,71;1,06]
    Hemorrhagic stroke 30 / 7329 (0,4%) 32 / 7312 (0,4%) 0,94 [0,57;1,54]
    Cardiovascular death 256 / 7329 (3,5%) 253 / 7312 (3,5%) 1,01 [0,85;1,20]
    Congestive heart failure 293 / 7329 (4,0%) 290 / 7312 (4,0%) 1,01 [0,86;1,18]
    Angina 718 / 7329 (9,8%) 765 / 7312 (10,5%) 0,94 [0,85;1,03]
    Revascularization 678 / 7329 (9,3%) 706 / 7312 (9,7%) 0,96 [0,87;1,06]
    Total mortality 857 / 7329 (11,7%) 804 / 7312 (11,0%) 1,06 [0,97;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]

    stroke (fatal and non fatal)

    218 / 7329
         246 / 7312
         0,88 [0,74;1,06]

    Cardiovascular death

    256 / 7329
         253 / 7312
         1,01 [0,85;1,20]

    Haemmorhagic stroke

    30 / 7329
         32 / 7312
         0,94 [0,57;1,54]

    All cause death

    857 / 7329
         804 / 7312
         1,06 [0,97;1,16]

    ischemic stroke

    180 / 7329
         207 / 7312
         0,87 [0,71;1,06]

    cardiovascular events

    619 / 7329
         626 / 7312
         0,99 [0,89;1,10]     0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial    		 Ref
    Studied treat. Control treat.
    stroke (fatal and non fatal) 218 / 7329 (3,0%) 246 / 7312 (3,4%) 0,88 [0,74;1,06]   0
    ischemic stroke 180 / 7329 (2,5%) 207 / 7312 (2,8%) 0,87 [0,71;1,06]   0
    Cardiovascular death 256 / 7329 (3,5%) 253 / 7312 (3,5%) 1,01 [0,85;1,20]   0
    cardiovascular events 619 / 7329 (8,4%) 626 / 7312 (8,6%) 0,99 [0,89;1,10]   0
    All cause death 857 / 7329 (11,7%) 804 / 7312 (11,0%) 1,06 [0,97;1,16]   0
    Haemmorhagic stroke 30 / 7329 (0,4%) 32 / 7312 (0,4%) 0,94 [0,57;1,54]   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 (for a follow-up of 8 years (mean))
    Endpoint Events rate Absolute risk
    reduction (ARR)
    Studied treat. Control treat.
    stroke (fatal and non fatal) 2,97% 3,36% -0,39%
    ischemic stroke 2,46% 2,83% -0,37%
    Cardiovascular death 3,49% 3,46% 0,03%
    cardiovascular events 8,45% 8,56% -0,12%
    All cause death 11,69% 11,00% 0,70%
    Haemmorhagic stroke 4,09‰ 4,38‰ -0,03%

    Meta-analysis of all similar trials:

    antioxydants in cardiovascular prevention for all type of patients

    antioxydants in cardiovascular prevention for primary prevention



    Reference(s)

    TrialResults-center ID TRC8811
    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;:
      Pubmed | Hubmed | Fulltext

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