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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

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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, vit B12 and vit B6
  •  
     SU.FOL.OM3 study, TRC11320 
    [ISRCTN41926726] download pdf: folic acid, vit B12 and vit B6 | plasma homocysteine lowering intervention for cardiovascular prevention

    Treatments

    Studied treatment supplementation with natural foLate, vitamin B6 and B12
    5-methyl-THF (560 µg), vitamin B6 (3 mg) and B12 (20 µg)
    Control treatment placebo
    Remarks factorial design with as 2nd comparison omega 3 fatty acids (600 mg of eicosapentanoic acid and docosahexaenoic acid at a ratio of 2:1) versus placebo

    Patients

    Patients patients with coronary or cerebral event within the previous 12 months
    Exclusion criteria Age <45 years or >80 years; Cardiovascular pathology not well defined; Patients that are incapable of understanding the study protocol; Patients with a pathology that might interfere with homocysteine or omega-3 fatty acid metabolism, in particular those that use methotrexate for the treatment of a cancer or rheumatoid arthritis and chronic renal failure (plasma level of creatinine >200 µmol/l or creatinine clearance <40 ml/min); Patients with a non-cardiovascular pathology with a suspected survival time less than the 5 years period of the study (solid cancer, evolved dementia, leukemia etc.)

    Method and design

    Randomized effectives 1242 / 1259 (studied vs. control)
    Design Parallel groups
    Blinding double-blind
    Geographic area France
    Primary endpoint MI, stroke, CV death


    Results



    Endpoints and data reported in the trial's publication(s)

    Endpoint Events (%) Relative Risk 95% CI
    Studied treat. Control treat.
    Major cardiovascular events 75 / 1242 (6,0%) 82 / 1259 (6,5%) 0,93 [0,68;1,26]
    Non-fatal myocardial infarction 28 / 1242 (2,3%) 32 / 1259 (2,5%) 0,89 [0,54;1,46]
    All coronary events 49 / 1242 (3,9%) 55 / 1259 (4,4%) 0,90 [0,62;1,32]
    Stroke 21 / 1242 (1,7%) 36 / 1259 (2,9%) 0,59 [0,35;1,01]
    All cerebrovascular events 35 / 1242 (2,8%) 48 / 1259 (3,8%) 0,74 [0,48;1,13]
    All revascularisations 155 / 1242 (12,5%) 153 / 1259 (12,2%) 1,03 [0,83;1,27]
    Other cardiovascular events 224 / 1242 (18,0%) 212 / 1259 (16,8%) 1,07 [0,90;1,27]
    All deaths 72 / 1242 (5,8%) 45 / 1259 (3,6%) 1,62 [1,13;2,33]

    Endpoints used by the meta-analysis and data retained for this trial

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

    All cause death

    72 / 1242
    45 / 1259
    classic 1,62 [1,13;2,33]

    stroke (fatal and non fatal)

    21 / 1242
    36 / 1259
    0,59 [0,35;1,01]

    Non fatal MI

    28 / 1242
    32 / 1259
    0,89 [0,54;1,46]

    Non fatal MI

    49 / 1242
    55 / 1259
    0,90 [0,62;1,32]

    cardiovascular events

    75 / 1242
    82 / 1259
    0,93 [0,68;1,26]
    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 72 / 1242 (5,8%) 45 / 1259 (3,6%) 1,62 [1,13;2,33] All deaths 
    Non fatal MI 49 / 1242 (3,9%) 55 / 1259 (4,4%) 0,90 [0,62;1,32] All coronary events 
    cardiovascular events 75 / 1242 (6,0%) 82 / 1259 (6,5%) 0,93 [0,68;1,26] Major cardiovascular events 
    Non fatal MI 28 / 1242 (2,3%) 32 / 1259 (2,5%) 0,89 [0,54;1,46] Non-fatal myocardial infarction 
    stroke (fatal and non fatal) 21 / 1242 (1,7%) 36 / 1259 (2,9%) 0,59 [0,35;1,01] Stroke 
    The primary endpoint (if exists) appears in blod characters
    Reference(s) used for data extraction:

    Endpoint studied treat. control treat. mean diff

    Absolute risk reduction (for a follow-up of )
    Endpoint Events rate Absolute risk
    reduction (ARR)
    Studied treat. Control treat.
    All cause death 5,80% 3,57% 2,2%
    Non fatal MI 3,95% 4,37% -0,42%
    cardiovascular events 6,04% 6,51% -0,47%
    Non fatal MI 2,25% 2,54% -0,29%
    stroke (fatal and non fatal) 1,69% 2,86% -1,17%

    Meta-analysis of all similar trials:

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



    Reference(s)

    TrialResults-center ID TRC11320
    Trials register # ISRCTN41926726
    • Galan P, Kesse-Guyot E, Czernichow S, Briancon S, Blacher J, Hercberg S. Effects of B vitamins and omega 3 fatty acids on cardiovascular diseases: a randomised placebo controlled trial.. BMJ 2010;341:c6273
      Pubmed | Hubmed | Fulltext

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