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Systematic review and meta-analysis

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

cardiovascular prevention - antioxydants - patients with renal disease

cardiovascular prevention - antioxydants - secondary prevention


Related trials

WACS vitamin E, 2007 - vitamin E vs placebo

WACS vitamin C, 2007 - vitamin C vs placebo

WACS beta-caroten, 2007 - beta carotene vs placebo

HOPE renal insufficiency subgroup, 2004 - vitamin E vs placebo

Tepel, 2003 - acetylcysteine vs placebo

WAVE (Waters), 2002 - combination vs placebo

HPS antioxidant, 2002 - combination vs placebo

HATS, 2001 - combination vs placebo

HOPE, 2000 - vitamin E vs placebo

SPACE, 2000 - vitamin E vs placebo

GISSI, 1999 - vitamin E vs control

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

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

MVP, 1997 - combination 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
  •  

    SPACE study, 2000

    download pdf: vitamin E | antioxydants for cardiovascular prevention

    Treatments

    Studied treatment vitamin E 800 IU daily
    Control treatment matching placebo

    Patients

    Patients Haemodialysis patients aged 40–75 years with pre-existing cardiovascular disease
    Baseline characteristics
    Women (%) 31% 
    age (yr) 64.5y 

    Method and design

    Randomized effectives 97 / 99 (studied vs. control)
    Design Parallel groups
    Blinding double -blind
    Follow-up duration 1.42 years
    Number of centre 6
    Geographic area Israel
    Hypothesis Superiority
    Primary endpoint MI, stroke, PVD, unstable angina


    Results

    Endpoint Studied treat.
    n/N
    Control treat.
    n/N
    Graph RR [95% CI]

    Coronary event

    8 / 97
    18 / 99
    0,45 [0,21;0,99]

    Cardiovascular death

    9 / 97
    15 / 99
    0,61 [0,28;1,33]

    cardiovascular events

    18 / 97
    34 / 99
    0,54 [0,33;0,89]

    All cause death

    31 / 97
    29 / 99
    1,09 [0,72;1,66]

    stroke (fatal and non fatal)

    5 / 97
    6 / 99
    classic 0,85 [0,27;2,70]

    ischemic stroke

    5 / 97
    6 / 99
    classic 0,85 [0,27;2,70]
    0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial
    Ref
    Studied treat. Control treat.
    Coronary event 8 / 97 (8,2%) 18 / 99 (18,2%) 0,45 [0,21;0,99] MI including SD 2948
    Cardiovascular death 9 / 97 (9,3%) 15 / 99 (15,2%) 0,61 [0,28;1,33] 2948
    cardiovascular events 18 / 97 (18,6%) 34 / 99 (34,3%) 0,54 [0,33;0,89] including sudden death 2948
    All cause death 31 / 97 (32,0%) 29 / 99 (29,3%) 1,09 [0,72;1,66] 2948
    stroke (fatal and non fatal) 5 / 97 (5,2%) 6 / 99 (6,1%) 0,85 [0,27;2,70] 2948
    ischemic stroke 5 / 97 (5,2%) 6 / 99 (6,1%) 0,85 [0,27;2,70] BMJ 2010 13777
    The primary endpoint (if exists) appears in blod characters
    Reference(s) used for data extraction:
  • 2948: Boaz M, Smetana S, Weinstein T, Matas Z, Gafter U, Iaina A, Knecht A, Weissgarten Y, Brunner D, Fainaru M, Green MSSecondary prevention with antioxidants of cardiovascular disease in endstage renal disease (SPACE): randomised placebo-controlled trial.Lancet 2000 Oct 7;356:1213-8
  • 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
  • 0:

  • Endpoint studied treat. control treat. mean diff

    Absolute risk reduction
    Endpoint Events rate Absolute risk
    reduction (ARR)
    Studied treat. Control treat.
    Coronary event 8,25% 18,18% -99,3‰
    Cardiovascular death 9,28% 15,15% -58,7‰
    cardiovascular events 18,56% 34,34% -157,9‰
    All cause death 31,96% 29,29% 2,7%
    stroke (fatal and non fatal) 5,15% 6,06% -9,1‰
    ischemic stroke 5,15% 6,06% -9,1‰

    Meta-analysis of all similar trials:

    antioxydants in cardiovascular prevention for patients with renal disease

    antioxydants in cardiovascular prevention for secondary prevention



    Reference(s)

    Trials register # NA
    • Boaz M, Smetana S, Weinstein T, Matas Z, Gafter U, Iaina A, Knecht A, Weissgarten Y, Brunner D, Fainaru M, Green MS. Secondary prevention with antioxidants of cardiovascular disease in endstage renal disease (SPACE): randomised placebo-controlled trial.. Lancet 2000 Oct 7;356:1213-8
      Pubmed | Hubmed | Fulltext

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