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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


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

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See also:

  • All cardiovascular prevention clinical trials
  • All clinical trials of antioxydants
  • All clinical trials of vitamin E
  •  
     ASAP study, 2000 TRC11242 
    download pdf: vitamin E | antioxydants for cardiovascular prevention

    Treatments

    Studied treatment d-alpha-tocopherol 91 mg (136 IU) twice daily
    Control treatment placebo

    Patients

    Patients smoking and nonsmoking men and postmenopausal women aged 45-69 years with serum cholesterol >= 5.0 mmol/l
    Inclusion criteria hypercholesterolemiadefined as serum cholesterol >=5.0 mmol/L (193 mg/dL) at screening
    Exclusion criteria regular intake of antioxidants, acetosalicylate, or any other drug with antioxidative properties, severe obesity (body mass index >32 kg/m2), type 1 diabetes, uncontrolled hypertension (sitting diastolic blood pressure >105 mm Hg), any condition limiting mobility, or severe disease shortening life expectancy; premenopausal women; oral estrogen therapy
    Baseline characteristics
    Women (%) 51% 
    age (yr) 59.7 y 

    Method and design

    Randomized effectives 260 / 260 (studied vs. control)
    Design Factorial plan
    Blinding double-blind
    Follow-up duration 3 years
    Number of centre NA
    Geographic area Finland
    Hypothesis Superiority
    Primary endpoint carotid artery mean intima-media thickness
    Remarks after the double-blind 3-year period, the study was continued for another 3 years as an open study


    Results

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

    All cause death

    4 / 260
    2 / 260
    classic 2,00 [0,37;10,82]
    0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial
    Ref
    Studied treat. Control treat.
    All cause death 4 / 260 (1,5%) 2 / 260 (0,8%) 2,00 [0,37;10,82]   13135
    The primary endpoint (if exists) appears in blod characters
    Reference(s) used for data extraction:
  • 13135: Salonen JT, Nyyssönen K, Salonen R, Lakka HM, Kaikkonen J, Porkkala-Sarataho E, Voutilainen S, Lakka TA, Rissanen T, Leskinen L, Tuomainen TP, Valkonen VP, Ristonmaa U, Poulsen HEAntioxidant Supplementation in Atherosclerosis Prevention (ASAP) study: a randomized trial of the effect of vitamins E and C on 3-year progression of carotid atherosclerosis.J Intern Med 2000;248:377-86
  • 0:

  • Endpoint studied treat. control treat. mean diff

    Absolute risk reduction (for a follow-up of 3 years)
    Endpoint Events rate Absolute risk
    reduction (ARR)
    Studied treat. Control treat.
    All cause death 1,54% 7,69‰ 0,77%

    Meta-analysis of all similar trials:

    antioxydants in cardiovascular prevention for all type of patients



    Reference(s)

    TrialResults-center ID TRC11242
    Trials register # NA
    • Leppälä JM, Virtamo J, Fogelholm R, Huttunen JK, Albanes D, Taylor PR, Heinonen OP. Controlled trial of alpha-tocopherol and beta-carotene supplements on stroke incidence and mortality in male smokers.. Arterioscler Thromb Vasc Biol 2000;20:230-5
      Pubmed | Hubmed | Fulltext
    • Salonen JT, Nyyssönen K, Salonen R, Lakka HM, Kaikkonen J, Porkkala-Sarataho E, Voutilainen S, Lakka TA, Rissanen T, Leskinen L, Tuomainen TP, Valkonen VP, Ristonmaa U, Poulsen HE. Antioxidant Supplementation in Atherosclerosis Prevention (ASAP) study: a randomized trial of the effect of vitamins E and C on 3-year progression of carotid atherosclerosis.. J Intern Med 2000;248:377-86
      Pubmed | Hubmed | Fulltext
    • Salonen RM, Nyyssönen K, Kaikkonen J, Porkkala-Sarataho E, Voutilainen S, Rissanen TH, Tuomainen TP, Valkonen VP, Ristonmaa U, Lakka HM, Vanharanta M, Salonen JT, Poulsen HE. Six-year effect of combined vitamin C and E supplementation on atherosclerotic progression: the Antioxidant Supplementation in Atherosclerosis Prevention (ASAP) Study.. Circulation 2003;107:947-53
      Pubmed | Hubmed | Fulltext

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