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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 vit B6
  •  
     WENBIT (vit B6) study, 2008 TRC9992 
    [NCT00354081] download pdf: vit B6 | plasma homocysteine lowering intervention for cardiovascular prevention

    Treatments

    Studied treatment vit B6 40mg 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

    Remarks / Comments



    Results

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

    All cause death

    28 / 771
    30 / 779
    0,94 [0,57;1,56]

    cardiovascular events

    106 / 771
    97 / 779
    1,10 [0,85;1,43]

    Non fatal MI

    55 / 771
    58 / 779
    0,96 [0,67;1,37]

    Cancer

    38 / 771
    31 / 779
    1,24 [0,78;1,97]
    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 28 / 771 (3,6%) 30 / 779 (3,9%) 0,94 [0,57;1,56]   11313
    Non fatal MI 55 / 771 (7,1%) 58 / 779 (7,4%) 0,96 [0,67;1,37]   11313
    cardiovascular events 106 / 771 (13,7%) 97 / 779 (12,5%) 1,10 [0,85;1,43]   11313
    Cancer 38 / 771 (4,9%) 31 / 779 (4,0%) 1,24 [0,78;1,97]   11313
    The primary endpoint (if exists) appears in blod characters
    Reference(s) used for data extraction:
  • 11313: Ebbing M, Bleie Ø, Ueland PM, Nordrehaug JE, Nilsen DW, Vollset SE, Refsum H, Pedersen EK, Nygård OJAMA 2008;300:795-804
  • 13312: B vitamins in patients with recent transient ischaemic attack or stroke in the VITAmins TO Prevent Stroke (VITATOPS) trial: a randomised, double-blind, parallel, placebo-controlled trial.Lancet Neurol 2010;:

  • 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 3,63% 3,85% -0,22%
    Non fatal MI 7,13% 7,45% -0,31%
    cardiovascular events 13,75% 12,45% 1,3%
    Cancer 4,93% 3,98% 0,95%

    Meta-analysis of all similar trials:

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



    Reference(s)

    TrialResults-center ID TRC9992
    Trials register # NCT00354081

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