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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


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WHS beta carotene, 1999 - beta carotene vs placebo

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

MVP, 1997 - combination vs placebo

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See also:

  • All cardiovascular prevention clinical trials
  • All clinical trials of antioxydants
  • All clinical trials of beta carotene
    		•  

    PHS beta carotene study, 1996

    download pdf: beta carotene | antioxydants for cardiovascular prevention

    Treatments

    Studied treatment beta carotene 50 mg on alternate days
    Control treatment placebo
    Remarks factorial design that tested aspirin and beta carotene

    Patients

    Patients male physicians, 40 to 84 years of age with no history of cancer (except nonmelanoma skin cancer), myocardial infarction, stroke, or transient cerebral ischemia
    Baseline characteristics
    Women (%) 0% 

    Method and design

    Randomized effectives 11036 / 1035 (studied vs. control)
    Design Factorial plan
    Blinding double-blind
    Follow-up duration 12 y
    Geographic area USA
    Hypothesis Superiority
    Primary endpoint neoplasm except nonmelanoma skin cancer


    Results



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

    Endpoint Events (%) Relative Risk 95% CI
    Studied treat. Control treat.
    Myocardial infarction 468 / 11036 (4,2%) 489 / 1035 (47,2%) 0,09 [0,08;0,10]
    Stroke 367 / 11036 (3,3%) 382 / 1035 (36,9%) 0,09 [0,08;0,10]
    Death from cardiovascular causes 338 / 11036 (3,1%) 313 / 1035 (30,2%) 0,10 [0,09;0,12]
    All important cardiovascular events 967 / 11036 (8,8%) 972 / 1035 (93,9%) 0,09 [0,09;0,10]
    Death from all causes 979 / 11036 (8,9%) 968 / 1035 (93,5%) 0,09 [0,09;0,10]

    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

    468 / 11036
         489 / 1035
         0,09 [0,08;0,10]

    Cardiovascular death

    338 / 11036
         313 / 1035
         0,10 [0,09;0,12]

    cardiovascular events

    967 / 11036
         972 / 1035
         0,09 [0,09;0,10]

    All cause death

    979 / 11036
         968 / 1035
         0,09 [0,09;0,10]

    stroke (fatal and non fatal)

    367 / 11036
         382 / 1035
         0,09 [0,08;0,10]     0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial    		 Ref
    Studied treat. Control treat.
    Coronary event 468 / 11036 (4,2%) 489 / 1035 (47,2%) 0,09 [0,08;0,10] Myocardial infarction 
    Cardiovascular death 338 / 11036 (3,1%) 313 / 1035 (30,2%) 0,10 [0,09;0,12] Death from cardiovascular causes  
    cardiovascular events 967 / 11036 (8,8%) 972 / 1035 (93,9%) 0,09 [0,09;0,10] All important cardiovascular events 
    All cause death 979 / 11036 (8,9%) 968 / 1035 (93,5%) 0,09 [0,09;0,10] Death from all causes 
    stroke (fatal and non fatal) 367 / 11036 (3,3%) 382 / 1035 (36,9%) 0,09 [0,08;0,10] 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 4,24% 47,25% -430,1‰
    Cardiovascular death 3,06% 30,24% -271,8‰
    cardiovascular events 8,76% 93,91% -851,5‰
    All cause death 8,87% 93,53% -846,6‰
    stroke (fatal and non fatal) 3,33% 36,91% -335,8‰

    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 # NA
    • Hennekens CH, Buring JE, Manson JE, Stampfer M, Rosner B, Cook NR, Belanger C, LaMotte F, Gaziano JM, Ridker PM, Willett W, Peto R. Lack of effect of long-term supplementation with beta carotene on the incidence of malignant neoplasms and cardiovascular disease.. N Engl J Med 1996 May 2;334:1145-9
      Pubmed | Hubmed | Fulltext

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