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See also:

  • All cardiovascular prevention clinical trials
  • All post myocardial infarction clinical trials
  • All clinical trials of HDL increasing drugs
  • All clinical trials of bezafibrate
  •  
     BIP study, 2000 TRC2584 
    download pdf: bezafibrate | cholesterol lowering intervention for post myocardial infarction

    Treatments

    Studied treatment bezafibrate 400 mg/d
    Control treatment placebo
    Concomittant treatment Régime; colestipol à 165 patients (57 dans le groupe bezafibrate et 107 dans le groupe contrôle)

    Patients

    Patients patients with a previous myocardial infarction or stable angina, total cholesterol of 180 to 250 mg/dL, HDL-C < or =45 mg/dL, triglycerides < or =300 mg/dL, and low-density lipoprotein cholesterol < or =180 mg/dL
    Inclusion criteria age of 45 to 74 years, history of MI >=6 months but <5 years before enrollment into the study and/or stable angina pectoris confirmed by coronary angiography, and/or radionuclear studies or standard exercise tests; serum total cholesterol between 180 to 250 mg/dL, LDL-C <=180 mg/dL (>=160 mg/dL for patients ,50 years), HDL-C <=45 mg/dL, and triglycerides <=300 mg/dL
    Exclusion criteria insulin-dependent diabetes mellitus, severe heart failure, unstable angina pectoris, hepatic or renal failure, known sensitivity to bezafibrate, or current use of lipid-modifying drugs
    Baseline characteristics
    Age (mean), yrs 60 
    Women (%)
    prior MI or CHD (%) 100 
    Total cholesterol (mmol/l) 5.5 mmol/L 
    LDL (mmol/l) 3.84 mmol/L 
    HDL (mmol/l) 0.89 mmol/L 
    Triglycerides (mg/dl) 145 
    Diabetes(%) 10% 
    BMI (kg/m2) 26.7 
    Stroke history 1% 
    History of hypertension (%) 32% 

    Method and design

    Randomized effectives 1548 / 1542 (studied vs. control)
    Design Parallel groups
    Blinding double blind
    Follow-up duration 6.2 y
    Number of centre multicentre
    Geographic area Israel
    Hypothesis Superiority
    Primary endpoint IDM fatal ou non fatal ou décès coronarien


    Results

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

    Coronary event

    211 / 1548
    232 / 1542
    0,91 [0,76;1,08]

    All cause death

    161 / 1548
    152 / 1542
    1,06 [0,86;1,30]

    Coronary death

    61 / 1548
    60 / 1542
    1,01 [0,71;1,44]

    stroke (fatal and non fatal)

    72 / 1548
    77 / 1542
    0,93 [0,68;1,27]

    MACE

    522 / 1548
    559 / 1542
    0,93 [0,84;1,02]

    Non fatal MI

    150 / 1548
    172 / 1542
    0,87 [0,71;1,07]

    Coronary death and non fatal MI

    211 / 1548
    232 / 1542
    0,91 [0,76;1,08]

    cardiac death

    61 / 1548
    60 / 1542
    1,01 [0,71;1,44]

    non cardiovascular death

    66 / 1548
    64 / 1542
    1,03 [0,73;1,44]
    0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial
    Ref
    Studied treat. Control treat.
    Coronary event 211 / 1548 (13,6%) 232 / 1542 (15,0%) 0,91 [0,76;1,08]   0
    All cause death 161 / 1548 (10,4%) 152 / 1542 (9,9%) 1,06 [0,86;1,30]  
    Coronary death 61 / 1548 (3,9%) 60 / 1542 (3,9%) 1,01 [0,71;1,44]  
    stroke (fatal and non fatal) 72 / 1548 (4,7%) 77 / 1542 (5,0%) 0,93 [0,68;1,27]  
    MACE 522 / 1548 (33,7%) 559 / 1542 (36,3%) 0,93 [0,84;1,02] cardiac events + revasc  1750
    Non fatal MI 150 / 1548 (9,7%) 172 / 1542 (11,2%) 0,87 [0,71;1,07]  
    Coronary death and non fatal MI 211 / 1548 (13,6%) 232 / 1542 (15,0%) 0,91 [0,76;1,08]   1750
    cardiac death 61 / 1548 (3,9%) 60 / 1542 (3,9%) 1,01 [0,71;1,44]  
    non cardiovascular death 66 / 1548 (4,3%) 64 / 1542 (4,2%) 1,03 [0,73;1,44] noncardiac death  1750
    The primary endpoint (if exists) appears in blod characters
    Reference(s) used for data extraction:
  • 0:
  • 1750: ,Secondary prevention by raising HDL cholesterol and reducing triglycerides in patients with coronary artery disease: the Bezafibrate Infarction Prevention (BIP) study.Circulation 2000; 102:21-7

  • Endpoint studied treat. control treat. mean diff

    Absolute risk reduction (for a follow-up of 6.2 y)
    Endpoint Events rate Absolute risk
    reduction (ARR)
    Studied treat. Control treat.
    Coronary event 13,63% 15,05% -1,41%
    All cause death 10,40% 9,86% 0,54%
    Coronary death 3,94% 3,89% 0,05%
    stroke (fatal and non fatal) 4,65% 4,99% -0,34%
    MACE 33,72% 36,25% -2,53%
    Non fatal MI 9,69% 11,15% -1,46%
    Coronary death and non fatal MI 13,63% 15,05% -1,41%
    cardiac death 3,94% 3,89% 0,05%
    non cardiovascular death 4,26% 4,15% 0,11%

    Meta-analysis of all similar trials:

    cholesterol lowering intervention in cardiovascular prevention for all chronical situations

    cholesterol lowering intervention in post myocardial infarction for all type of patients

    HDL increasing drugs in cardiovascular prevention for all type of patients



    Reference(s)

    TrialResults-center ID TRC2584
    Trials register # NA
    • ,. Secondary prevention by raising HDL cholesterol and reducing triglycerides in patients with coronary artery disease: the Bezafibrate Infarction Prevention (BIP) study.. Circulation 2000; 102:21-7
      Pubmed | Hubmed | Fulltext
    • Goldenberg I, Boyko V, Tennenbaum A, Tanne D, Behar S, Guetta V. Long-term benefit of high-density lipoprotein cholesterol-raising therapy with bezafibrate: 16-year mortality follow-up of the bezafibrate infarction prevention trial.. Arch Intern Med 2009;169:508-14
      Pubmed | Hubmed | Fulltext

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