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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

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

FOLARDA (Liem), 2004 - folic acid vs control

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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
  •  
     NORVIT (folic acid, B12 and vit B6) (Bonaa) study, 2006 TRC4371 
    [NCT00266487] download pdf: folic acid, vit B12 and vit B6 | plasma homocysteine lowering intervention for cardiovascular prevention

    Treatments

    Studied treatment 0.8 mg of folic acid, 0.4 mg of vitamin B12, and 40 mg of vitamin B6
    Control treatment placebo
    Remarks factorial design of folic acid plus B12 and B6

    Patients

    Patients men and women who had had an acute myocardial infarction within seven days
    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 937 / 943 (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)


    Results

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

    stroke (fatal and non fatal)

    21 / 937
    27 / 943
    0,78 [0,45;1,37]

    Non fatal MI

    132 / 937
    104 / 943
    1,28 [1,00;1,62]

    Non fatal MI

    182 / 937
    153 / 943
    1,20 [0,99;1,45]

    cardiac death

    68 / 937
    59 / 943
    1,16 [0,83;1,62]

    All cause death

    104 / 937
    89 / 943
    1,18 [0,90;1,54]

    Cancer

    40 / 937
    40 / 943
    1,01 [0,66;1,55]

    cardiovascular events

    201 / 937
    172 / 943
    1,18 [0,98;1,41]
    0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial
    Ref
    Studied treat. Control treat.
    Non fatal MI 182 / 937 (19,4%) 153 / 943 (16,2%) 1,20 [0,99;1,45]   0
    Cancer 40 / 937 (4,3%) 40 / 943 (4,2%) 1,01 [0,66;1,55]  
    Non fatal MI 132 / 937 (14,1%) 104 / 943 (11,0%) 1,28 [1,00;1,62]  
    All cause death 104 / 937 (11,1%) 89 / 943 (9,4%) 1,18 [0,90;1,54]  
    cardiovascular events 201 / 937 (21,5%) 172 / 943 (18,2%) 1,18 [0,98;1,41]   0
    cardiac death 68 / 937 (7,3%) 59 / 943 (6,3%) 1,16 [0,83;1,62]  
    stroke (fatal and non fatal) 21 / 937 (2,2%) 27 / 943 (2,9%) 0,78 [0,45;1,37]   0
    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.
    Non fatal MI 19,42% 16,22% 3,2%
    Cancer 4,27% 4,24% 0,03%
    Non fatal MI 14,09% 11,03% 3,1%
    All cause death 11,10% 9,44% 1,7%
    cardiovascular events 21,45% 18,24% 3,2%
    cardiac death 7,26% 6,26% 1,0%
    stroke (fatal and non fatal) 2,24% 2,86% -0,62%

    Meta-analysis of all similar trials:

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



    Reference(s)

    TrialResults-center ID TRC4371
    Trials register # NCT00266487
    • 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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