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See also:

  • All cardiovascular prevention clinical trials
  • All clinical trials of HDL increasing drugs
  • All clinical trials of clofibrate
    		•  
     Hanefeld study, 1991 TRC10780 
    download pdf: clofibrate | cholesterol lowering intervention for cardiovascular prevention

    Treatments

    Studied treatment clofibric acid 1.6 g/day
    Control treatment placebo

    Patients

    Patients newly diagnosed middle-aged (30- to 55-yr-old) patients with non-insulin-dependent diabetes mellitus
    Baseline characteristics
    Age (mean), yrs 46 
    Women (%) 44% 
    Total cholesterol (mmol/l) 5.71 mmol/L 
    Diabetes(%) 100% 

    Method and design

    Randomized effectives 379 / 382 (studied vs. control)
    Design Parallel groups
    Blinding double-blind
    Follow-up duration 5 years
    Geographic area Germany
    Primary endpoint NA


    Results

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

    Coronary event

    32 / 379
         31 / 382
         1,04 [0,65;1,67]     0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial    		 Ref
    Studied treat. Control treat.
    Coronary event 32 / 379 (8,4%) 31 / 382 (8,1%) 1,04 [0,65;1,67]   12545
    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
    total cholesterol (at 1 y) 5,96 (1,41) 6,06 (1,4) -0,10 [-0,300;0,10]

    Absolute risk reduction (for a follow-up of 5 years)
    Endpoint Events rate Absolute risk
    reduction (ARR)
    Studied treat. Control treat.
    Coronary event 8,44% 8,12% 0,33%

    Meta-analysis of all similar trials:

    cholesterol lowering intervention in cardiovascular prevention for diabetic patients

    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 TRC10780
    Trials register # NA
    • Hanefeld M, Fischer S, Schmechel H, Rothe G, Schulze J, Dude H, Schwanebeck U, Julius U. Diabetes Intervention Study. Multi-intervention trial in newly diagnosed NIDDM.. Diabetes Care 1991;14:308-17
      Pubmed | Hubmed | Fulltext

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