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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 - secondary prevention


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PPP, 2001 - vitamin E vs control

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HATS, 2001 - combination vs placebo

ASAP, 2000 - vitamin E vs placebo

SPACE, 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

ATBC 2nd prev subgroup (b carotene), 1998 - beta carotene vs placebo

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



See also:

  • All cardiovascular prevention clinical trials
  • All clinical trials of antioxydants
  • All clinical trials of vitamin E
    		•  

    GISSI study, 1999

    download pdf: vitamin E | antioxydants for cardiovascular prevention

    Treatments

    Studied treatment vitamin E 300mg/d
    Control treatment no vitamine E
    Remarks randomization between 4 treatment: n-3 PUFA (1 g daily), vitamin E (300 mg daily), both or none (control)

    Patients

    Patients patients with recent (3 months) myocardial infarction
    Inclusion criteria no age limits
    Exclusion criteria contraindications to the dietary supplements (ie, known allergy to n-3 PUFA or á- tocopherol, or known congenital defects of coagulation); unfavourable short-term outlook (eg, overt congestive heart failure, cancers, etc)
    Baseline characteristics
    Women (%) 14.7% 
    age (yr) 59.4 (15.2% > 70 y) 
    Body mass index 26.5 

    Method and design

    Randomized effectives 5660 / 5664 (studied vs. control)
    Design Factorial plan
    Blinding open
    Follow-up duration 3.5y
    Number of centre multicentre
    Geographic area Italy
    Hypothesis Superiority
    Primary endpoint death, MI, stroke


    Results



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

    Endpoint Events (%) Relative Risk 95% CI
    Studied treat. Control treat.
    Death, non-fatal MI, and non-fatal stroke 730 / 5666 (12,9%) 770 / 5668 (13,6%) 0,95 [0,86;1,04]
    Cardiovascular death, non-fatal MI, and non-fatal stroke 571 / 5666 (10,1%) 584 / 5668 (10,3%) 0,98 [0,88;1,09]
    All fatal events 488 / 5666 (8,6%) 529 / 5668 (9,3%) 0,92 [0,82;1,04]
    Cardiovascular deaths 310 / 5666 (5,5%) 329 / 5668 (5,8%) 0,94 [0,81;1,10]
    Cardiac death 247 / 5666 (4,4%) 273 / 5668 (4,8%) 0,91 [0,77;1,07]
    Coronary death 228 / 5666 (4,0%) 251 / 5668 (4,4%) 0,91 [0,76;1,08]
    Sudden death 132 / 5666 (2,3%) 154 / 5668 (2,7%) 0,86 [0,68;1,08]
    Other deaths 178 / 5666 (3,1%) 200 / 5668 (3,5%) 0,89 [0,73;1,09]
    Non-fatal cardiovascular events 294 / 5666 (5,2%) 284 / 5668 (5,0%) 1,04 [0,88;1,21]
    CHD death and non-fatal MI 454 / 5666 (8,0%) 455 / 5668 (8,0%) 1,00 [0,88;1,13]
    Fatal and non-fatal stroke 83 / 5666 (1,5%) 95 / 5668 (1,7%) 0,87 [0,65;1,17]

    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

    310 / 5660
         329 / 5664
         0,94 [0,81;1,10]

    Non fatal MI

    226 / 5660
         204 / 5664
         1,11 [0,92;1,33]

    cardiovascular events

    571 / 5660
         584 / 5664
         0,98 [0,88;1,09]

    All cause death

    488 / 5666
         529 / 5668
         0,92 [0,82;1,04]

    stroke (fatal and non fatal)

    83 / 5666
         95 / 5668
         0,87 [0,65;1,17]

    Non fatal stroke

    83 / 5660
         95 / 5664
         0,87 [0,65;1,17]     0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial    		 Ref
    Studied treat. Control treat.
    Cardiovascular death 310 / 5660 (5,5%) 329 / 5664 (5,8%) 0,94 [0,81;1,10]  
    Non fatal MI 226 / 5660 (4,0%) 204 / 5664 (3,6%) 1,11 [0,92;1,33]  
    cardiovascular events 571 / 5660 (10,1%) 584 / 5664 (10,3%) 0,98 [0,88;1,09]  
    All cause death 488 / 5666 (8,6%) 529 / 5668 (9,3%) 0,92 [0,82;1,04] All fatal events 
    stroke (fatal and non fatal) 83 / 5666 (1,5%) 95 / 5668 (1,7%) 0,87 [0,65;1,17] Fatal and non-fatal stroke  0
    Non fatal stroke 83 / 5660 (1,5%) 95 / 5664 (1,7%) 0,87 [0,65;1,17]  
    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 5,48% 5,81% -3,3‰
    Non fatal MI 3,99% 3,60% 3,9‰
    cardiovascular events 10,09% 10,31% -2,2‰
    All cause death 8,61% 9,33% -7,2‰
    stroke (fatal and non fatal) 1,46% 1,68% -2,1‰
    Non fatal stroke 1,47% 1,68% -2,1‰

    Meta-analysis of all similar trials:

    antioxydants in cardiovascular prevention for all type of patients

    antioxydants in cardiovascular prevention for secondary prevention



    Reference(s)

    Trials register # NA
    • . Dietary supplementation with n-3 polyunsaturated fatty acids and vitamin E after myocardial infarction: results of the GISSI-Prevenzione trial. Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto miocardico.. Lancet 1999 Aug 7;354:447-55
      Pubmed | Hubmed | Fulltext

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