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Systematic review and meta-analysis

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

cardiovascular prevention - plasma homocysteine lowering intervention - all type of patients


Related trials

CSPPT, 2015 - folic acid vs placebo

VITATOPS, 2010 - folic acid, vit B12 and vit B6 vs placebo

WAFACS, 2008 - folic acid, vit B12 and vit B6 vs placebo

WENBIT (vit B6), 2008 - vit B6 vs placebo

WENBIT (folic ac,B12), 2008 - folic acid, B12 vs placebo

SEARCH, 2007 - folic acid, B12 vs placebo

NORVIT (folic acid + B12) (Bonaa), 2006 - folic acid, B12 vs control

NORVIT (folic acid, B12 and vit B6) (Bonaa), 2006 - folic acid, vit B12 and vit B6 vs control

NORVIT (vit B6) (Bonaa), 2006 - vit B6 vs control

HOPE-2 (Lonn), 2006 - folic acid, vit B12 and vit B6 vs placebo

FOLARDA (Liem), 2004 - folic acid vs control

VISP (Toole), 2004 - high dose - folic acid, vit B12 and vit B6 vs low dose - folic acid, vit B12 and vit B6

GOES (Liem), 2003 - folic acid vs control

CHAOS-2, 2002 - folic acid vs placebo

SU.FOL.OM3, - folic acid, vit B12 and vit B6 vs placebo



See also:

  • All cardiovascular prevention clinical trials
  • All clinical trials of plasma homocysteine lowering intervention
  • All clinical trials of folic acid, B12
  •  
     WENBIT (folic ac,B12) study, 2008 TRC9991 
    [NCT00354081] download pdf: folic acid, B12 | plasma homocysteine lowering intervention for cardiovascular prevention

    Treatments

    Studied treatment folic acid 0.8mg, vit B12 0.4mg daily
    Control treatment placebo
    Remarks 4 arms: folic acid+B12+B6, folic ac+B12, B6, placebo (2x2 factorial design B6 vs PBO, folic ac+B12 vs pbo)

    Patients

    Patients adult participants undergoing coronary angiography
    Exclusion criteria alcohol abuse; serious mental illness; cancer
    Baseline characteristics
    Age (yr) 61.5 yr 
    Male sex 78% 
    BMI 26.9 
    diabetes (%) NA 

    Method and design

    Randomized effectives 772 / 780 (studied vs. control)
    Design Factorial plan
    Blinding double blind
    Follow-up duration 38.4 mo
    Number of centre 2
    Geographic area Norway
    Hypothesis Superiority
    Primary endpoint all death, MI, unstable angina, stroke
    Remarks


    Results

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

    All cause death

    38 / 772
    30 / 780
    classic 1,28 [0,80;2,04]

    stroke (fatal and non fatal)

    17 / 772
    19 / 780
    0,90 [0,47;1,73]

    Cancer

    39 / 772
    31 / 780
    classic 1,27 [0,80;2,02]

    Non fatal MI

    76 / 772
    58 / 780
    1,32 [0,95;1,84]

    cardiovascular events

    125 / 772
    97 / 780
    1,30 [1,02;1,66]
    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 38 / 772 (4,9%) 30 / 780 (3,8%) 1,28 [0,80;2,04]   11312
    Non fatal MI 76 / 772 (9,8%) 58 / 780 (7,4%) 1,32 [0,95;1,84]   11312
    cardiovascular events 125 / 772 (16,2%) 97 / 780 (12,4%) 1,30 [1,02;1,66]   11312
    stroke (fatal and non fatal) 17 / 772 (2,2%) 19 / 780 (2,4%) 0,90 [0,47;1,73]   11312
    Cancer 39 / 772 (5,1%) 31 / 780 (4,0%) 1,27 [0,80;2,02]   11312
    The primary endpoint (if exists) appears in blod characters
    Reference(s) used for data extraction:
  • 11312: Ebbing M, Bleie Ø, Ueland PM, Nordrehaug JE, Nilsen DW, Vollset SE, Refsum H, Pedersen EK, Nygård OJAMA 2008;300:795-804

  • Endpoint studied treat. control treat. mean diff

    Absolute risk reduction (for a follow-up of 38.4 mo)
    Endpoint Events rate Absolute risk
    reduction (ARR)
    Studied treat. Control treat.
    All cause death 4,92% 3,85% 1,1%
    Non fatal MI 9,84% 7,44% 2,4%
    cardiovascular events 16,19% 12,44% 3,8%
    stroke (fatal and non fatal) 2,20% 2,44% -0,23%
    Cancer 5,05% 3,97% 1,1%

    Meta-analysis of all similar trials:

    plasma homocysteine lowering intervention in cardiovascular prevention for all type of patients



    Reference(s)

    TrialResults-center ID TRC9991
    Trials register # NCT00354081

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