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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
  •  
     GOES (Liem) study, 2003 TRC9990 
    download pdf: folic acid | plasma homocysteine lowering intervention for cardiovascular prevention

    Treatments

    Studied treatment folic acid 0.5 mg per day
    Control treatment usual care

    Patients

    Patients patients with stable coronary artery disease
    Exclusion criteria age below 18 years, history of low vitamin B12 level, treatment for hyperhomocysteinemia, severe renal failure, or any other treatment for renal disease, known hepatic disease, signs and symptoms of severe heart failure (New York Heart Association functional class IV) or any other serious illness that would exclude follow-up time of at least three years
    Baseline characteristics
    Age (yr) 65 y 
    Male sex 78% 
    BMI 27.0 

    Method and design

    Randomized effectives 300 / 293 (studied vs. control)
    Design Parallel groups
    Blinding open
    Follow-up duration 24 months
    Number of centre single center
    Geographic area The Netherlands
    Hypothesis Superiority
    Primary endpoint CV events


    Results

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

    All cause death

    12 / 300
    14 / 293
    0,84 [0,39;1,78]

    Non fatal MI

    3 / 300
    4 / 293
    classic 0,73 [0,17;3,24]

    cardiovascular events

    37 / 300
    33 / 293
    1,10 [0,70;1,70]

    Cardiovascular death

    7 / 300
    9 / 293
    classic 0,76 [0,29;2,01]

    stroke (fatal and non fatal)

    4 / 300
    3 / 293
    classic 1,30 [0,29;5,77]

    Non fatal MI

    3 / 300
    4 / 293
    classic 0,73 [0,17;3,24]
    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 12 / 300 (4,0%) 14 / 293 (4,8%) 0,84 [0,39;1,78]   11305
    Non fatal MI 3 / 300 (1,0%) 4 / 293 (1,4%) 0,73 [0,17;3,24]   11305
    cardiovascular events 37 / 300 (12,3%) 33 / 293 (11,3%) 1,10 [0,70;1,70]   11309
    Non fatal MI 3 / 300 (1,0%) 4 / 293 (1,4%) 0,73 [0,17;3,24]   11309
    Cardiovascular death 7 / 300 (2,3%) 9 / 293 (3,1%) 0,76 [0,29;2,01]   11309
    stroke (fatal and non fatal) 4 / 300 (1,3%) 3 / 293 (1,0%) 1,30 [0,29;5,77] CVA/TIA  11309
    The primary endpoint (if exists) appears in blod characters
    Reference(s) used for data extraction:
  • 11305: Martí-Carvajal AJ, Solà I, Lathyris D, Salanti GHomocysteine lowering interventions for preventing cardiovascular events.Cochrane Database Syst Rev 2009 Oct 7;:CD006612
  • 11309: Liem A, Reynierse-Buitenwerf GH, Zwinderman AH, Jukema JW, van Veldhuisen DJSecondary prevention with folic acid: effects on clinical outcomes.J Am Coll Cardiol 2003;41:2105-13

  • Endpoint studied treat. control treat. mean diff

    Absolute risk reduction (for a follow-up of 24 months)
    Endpoint Events rate Absolute risk
    reduction (ARR)
    Studied treat. Control treat.
    All cause death 4,00% 4,78% -0,78%
    Non fatal MI 1,00% 1,37% -0,37%
    cardiovascular events 12,33% 11,26% 1,1%
    Non fatal MI 1,00% 1,37% -0,37%
    Cardiovascular death 2,33% 3,07% -0,74%
    stroke (fatal and non fatal) 1,33% 1,02% 0,31%

    Meta-analysis of all similar trials:

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



    Reference(s)

    TrialResults-center ID TRC9990
    Trials register # NA
    • Liem A, Reynierse-Buitenwerf GH, Zwinderman AH, Jukema JW, van Veldhuisen DJ. Secondary prevention with folic acid: effects on clinical outcomes.. J Am Coll Cardiol 2003;41:2105-13
      Pubmed | Hubmed | Fulltext
    • Liem A, Reynierse-Buitenwerf GH, Zwinderman AH, Jukema JW, van Veldhuisen DJ. Secondary prevention with folic acid: results of the Goes extension study.. Heart 2005;91:1213-4 - 10.1136/hrt.2004.035030
      Pubmed | Hubmed | Fulltext

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