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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


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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

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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
  •  
     FOLARDA (Liem) study, 2004 TRC9989 
    download pdf: folic acid | plasma homocysteine lowering intervention for cardiovascular prevention

    Treatments

    Studied treatment folic acid 5 mg per day for 1 year
    Control treatment usual care

    Patients

    Patients patients with acute MI and total cholesterol >6.5 mmol/l
    Inclusion criteria total cholesterol value, taken at admission or within 24 h after onset of symptoms, was > 6.5 mmol/l;
    Exclusion criteria age < 18 years; use of lipid lowering agents within the previous 3 months; high triglyceride level > 4.5 mmol/l; known familial dyslipidaemia, low vitamin B12 level, previously known hyperhomocysteinaemia (total plasma homocysteine > 18 µmol/l); known disturbed methionine loading test (total plasmahomocysteine > 47 Amol/l); severe renal failure (serum creatinine >180 µmol/l); known hepatic disease; signs and symptoms of severe heart failure (NYHA class IV), and a scheduled percutaneous coronary intervention or coronary artery bypass graft
    Baseline characteristics
    Age (yr) 59 y 
    Male sex 69% 

    Method and design

    Randomized effectives 140 / 143 (studied vs. control)
    Design Parallel groups
    Blinding open
    Follow-up duration 1 year
    Number of centre multicentre
    Geographic area The Netherlands
    Hypothesis Superiority
    Primary endpoint not defined
    Remarks pilot trial


    Results

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

    All cause death

    6 / 140
    7 / 143
    classic 0,88 [0,30;2,54]

    stroke (fatal and non fatal)

    1 / 140
    0 / 143
    classic 5,11 [0,07;371,84]

    Non fatal MI

    8 / 140
    10 / 143
    classic 0,82 [0,33;2,01]
    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 6 / 140 (4,3%) 7 / 143 (4,9%) 0,88 [0,30;2,54]   11305
    Non fatal MI 8 / 140 (5,7%) 10 / 143 (7,0%) 0,82 [0,33;2,01]   11305
    stroke (fatal and non fatal) 1 / 140 (0,7%) 0 / 143 (0,3%) 2,04 [0,07;60,41]   11305
    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
  • 0:

  • Endpoint studied treat. control treat. mean diff

    Absolute risk reduction (for a follow-up of 1 year)
    Endpoint Events rate Absolute risk
    reduction (ARR)
    Studied treat. Control treat.
    All cause death 4,29% 4,90% -0,61%
    Non fatal MI 5,71% 6,99% -1,28%

    Meta-analysis of all similar trials:

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



    Reference(s)

    TrialResults-center ID TRC9989
    Trials register # NA
    • Liem AH, van Boven AJ, Veeger NJ, Withagen AJ, Robles de Medina RM, Tijssen JG, van Veldhuisen DJ. Efficacy of folic acid when added to statin therapy in patients with hypercholesterolemia following acute myocardial infarction: a randomised pilot trial.. Int J Cardiol 2004;93:175-9 - 10.1016/j.ijcard.2003.02.001
      Pubmed | Hubmed | Fulltext

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