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See also:

  • All cardiovascular prevention clinical trials
  • All clinical trials of HDL increasing drugs
  • All clinical trials of bezafibrate
    		•  
     LEADER study, 2002 TRC8164 
    download pdf: bezafibrate | cholesterol lowering intervention for cardiovascular prevention

    Treatments

    Studied treatment bezafibrate 400 mg daily
    Control treatment placebo

    Patients

    Patients men with lower extremity arterial disease
    Inclusion criteria NA
    Exclusion criteria NA
    Baseline characteristics
    Age (mean), yrs 68 
    Women (%) 0% 
    prior MI or CHD (%) 45 
    Total cholesterol (mmol/l) 7.1 mmol/L 
    Diabetes(%) 66% 

    Method and design

    Randomized effectives 783 / 785 (studied vs. control)
    Design Parallel groups
    Blinding double-blind
    Follow-up duration 4.6y
    Number of centre 85
    Geographic area UK
    Hypothesis Superiority
    Primary endpoint CHD, stroke


    Results

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

    Coronary event

    90 / 783
         111 / 785
         0,81 [0,63;1,05]

    All cause death

    204 / 783
         195 / 785
         1,05 [0,89;1,24]

    cardiovascular events

    150 / 783
         160 / 785
         0,94 [0,77;1,15]

    cardiac death

    127 / 783
         121 / 785
         1,05 [0,84;1,32]     0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial    		 Ref
    Studied treat. Control treat.
    Coronary event 90 / 783 (11,5%) 111 / 785 (14,1%) 0,81 [0,63;1,05]   12545
    All cause death 204 / 783 (26,1%) 195 / 785 (24,8%) 1,05 [0,89;1,24]  
    cardiovascular events 150 / 783 (19,2%) 160 / 785 (20,4%) 0,94 [0,77;1,15]   12545
    cardiac death 127 / 783 (16,2%) 121 / 785 (15,4%) 1,05 [0,84;1,32]  
    The primary endpoint (if exists) appears in blod characters
    Reference(s) used for data extraction:
  • 12545: Jun M, Foote C, Lv J, Neal B, Patel A, Nicholls SJ, Grobbee DE, Cass A, Chalmers J, Perkovic VEffects of fibrates on cardiovascular outcomes: a systematic review and meta-analysis.Lancet 2010 May 10;:
  • 0:

    • Endpoint studied treat. control treat. mean diff

    Absolute risk reduction (for a follow-up of 4.6y)
    Endpoint Events rate Absolute risk
    reduction (ARR)
    Studied treat. Control treat.
    Coronary event 11,49% 14,14% -2,65%
    All cause death 26,05% 24,84% 1,2%
    cardiovascular events 19,16% 20,38% -1,23%
    cardiac death 16,22% 15,41% 0,81%

    Meta-analysis of all similar trials:

    cholesterol lowering intervention in cardiovascular prevention for patients with other atherosclerotic localisation

    cholesterol lowering intervention in cardiovascular prevention for all chronical situations

    HDL increasing drugs in cardiovascular prevention for all type of patients



    Reference(s)

    TrialResults-center ID TRC8164
    Trials register # NA
    • Meade T, Zuhrie R, Cook C, Cooper J. Bezafibrate in men with lower extremity arterial disease: randomised controlled trial.. BMJ 2002;325:1139
      Pubmed | Hubmed | Fulltext

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