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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

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

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

WENBIT (vit B6), 2008 - vit B6 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

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

FOLARDA (Liem), 2004 - folic acid vs control

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
  •  
     NORVIT (folic acid + B12) (Bonaa) study, 2006 TRC3437 
    [NCT00266487] download pdf: folic acid, B12 | plasma homocysteine lowering intervention for cardiovascular prevention

    Treatments

    Studied treatment folic acid 0.8mg and B12 0.4 mg daily
    Control treatment no folic acid and B12
    Concomittant treatment patients received vit B6 or its placebo (factorial design)
    Remarks patients received also Vit B6 or placebo in a two by two factorial design

    Patients

    Patients men and women who had had an acute myocardial infarction within seven days before
    Exclusion criteria coexisting disease associated with a life expectancy of less than four years, prescribed treatment with B vitamins or untreated vitamin B deficiency, or inability to follow the protocol
    Baseline characteristics
    Age (yr) 63 y 
    Male sex 74% 
    BMI 26.2 
    diabetes (%) 10% 

    Method and design

    Randomized effectives 1872 / 1877 (studied vs. control)
    Design Factorial plan
    Blinding double-blind
    Follow-up duration 36 months
    Number of centre multicenter
    Geographic area Norway
    Hypothesis Superiority
    Primary endpoint CV events (fatal and non ftala MI, stroke, sudden death)
    Remarks

    Remarks / Comments



    Results

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

    All cause death

    184 / 1872
    181 / 1877
    1,02 [0,84;1,24]

    cardiac death

    115 / 1872
    120 / 1877
    0,96 [0,75;1,23]

    Cancer

    79 / 1872
    65 / 1877
    1,22 [0,88;1,68]

    cardiovascular events

    369 / 1872
    347 / 1877
    1,07 [0,93;1,22]

    stroke (fatal and non fatal)

    49 / 1872
    49 / 1877
    1,00 [0,68;1,48]

    Non fatal MI

    245 / 1872
    217 / 1877
    1,13 [0,95;1,34]
    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 184 / 1872 (9,8%) 181 / 1877 (9,6%) 1,02 [0,84;1,24]  
    cardiovascular events 369 / 1872 (19,7%) 347 / 1877 (18,5%) 1,07 [0,93;1,22]   0
    Non fatal MI 245 / 1872 (13,1%) 217 / 1877 (11,6%) 1,13 [0,95;1,34]  
    stroke (fatal and non fatal) 49 / 1872 (2,6%) 49 / 1877 (2,6%) 1,00 [0,68;1,48]   0
    cardiac death 115 / 1872 (6,1%) 120 / 1877 (6,4%) 0,96 [0,75;1,23]  
    Cancer 79 / 1872 (4,2%) 65 / 1877 (3,5%) 1,22 [0,88;1,68]  
    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 (for a follow-up of 36 months)
    Endpoint Events rate Absolute risk
    reduction (ARR)
    Studied treat. Control treat.
    All cause death 9,83% 9,64% 0,19%
    cardiovascular events 19,71% 18,49% 1,2%
    Non fatal MI 13,09% 11,56% 1,5%
    stroke (fatal and non fatal) 2,62% 2,61% 0,01%
    cardiac death 6,14% 6,39% -0,25%
    Cancer 4,22% 3,46% 0,76%

    Meta-analysis of all similar trials:

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



    Reference(s)

    TrialResults-center ID TRC3437
    Trials register # NCT00266487
    Study web site link http://www.medscape.com/viewarticle/512905
    • Bønaa KH, Njølstad I, Ueland PM, Schirmer H, Tverdal A, Steigen T, Wang H, Nordrehaug JE, Arnesen E, Rasmussen K. Homocysteine lowering and cardiovascular events after acute myocardial infarction.. N Engl J Med 2006;354:1578-88 - 10.1056/NEJMoa055227
      Pubmed | Hubmed | Fulltext

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