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See also:

  • All cardiovascular prevention clinical trials
  • All clinical trials of HDL increasing drugs
  • All clinical trials of bezafibrate
    		•  
     SENDCAP study, 1998 TRC8163 
    download pdf: bezafibrate | cholesterol lowering intervention for cardiovascular prevention

    Treatments

    Studied treatment bezafibrate 400 mg daily
    Control treatment placebo

    Patients

    Patients type 2 diabetic subjects without a history of clinical cardiovascular
    Baseline characteristics
    Age (mean), yrs 51 
    Women (%) 29% 
    prior MI or CHD (%) 0 
    Total cholesterol (mmol/l) 12.3 mmol/L 
    Diabetes(%) 100% 
    LDL change, end of study (mg/DL) -0.3 mmol/L 

    Method and design

    Randomized effectives 81 / 83 (studied vs. control)
    Design Parallel groups
    Blinding double blind
    Follow-up duration 3.0 years
    Geographic area UK
    Primary endpoint B-mode ultrasound


    Results

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

    Coronary event

    6 / 81
         17 / 83
         0,36 [0,15;0,87]

    All cause death

    0 / 81
         1 / 83
         classic 0,20 [0,00;14,85]

    cardiac death

    0 / 81
         0 / 83
         classic 1,02 [0,00;259,73]     0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial    		 Ref
    Studied treat. Control treat.
    Coronary event 6 / 81 (7,4%) 17 / 83 (20,5%) 0,36 [0,15;0,87]   12545
    All cause death 0 / 81 (0,6%) 1 / 83 (1,2%) 0,51 [0,02;15,06]  
    cardiac death 0 / 81 (0,6%) 0 / 83 (0,6%) 1,02 [0,02;51,03]  
    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 3.0 years)
    Endpoint Events rate Absolute risk
    reduction (ARR)
    Studied treat. Control treat.
    Coronary event 7,41% 20,48% -13,07%

    Meta-analysis of all similar trials:

    cholesterol lowering intervention in cardiovascular prevention for all chronical situations

    cholesterol lowering intervention in cardiovascular prevention for diabetic patients

    cholesterol lowering intervention in cardiovascular prevention for patients with prior MI or with CHD

    HDL increasing drugs in cardiovascular prevention for all type of patients



    Reference(s)

    TrialResults-center ID TRC8163
    Trials register # NA
    • Elkeles RS, Diamond JR, Poulter C, Dhanjil S, Nicolaides AN, Mahmood S, Richmond W, Mather H, Sharp P, Feher MD. Cardiovascular outcomes in type 2 diabetes. A double-blind placebo-controlled study of bezafibrate: the St. Mary's, Ealing, Northwick Park Diabetes Cardiovascular Disease Prevention (SENDCAP) Study.. Diabetes Care 1998;21:641-8
      Pubmed | Hubmed | Fulltext

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