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See also:

  • All cardiovascular prevention clinical trials
  • All clinical trials of cholesterol lowering intervention
  • All clinical trials of pravastatin
  •  

    WOSCOPS study, 1995

    download pdf: pravastatin | cholesterol lowering intervention for cardiovascular prevention

    Treatments

    Studied treatment pravastatine 40 mg daily
    Control treatment placebo
    Concomittant treatment diet
    Treatments description
    total cholesterol change 20.0% 
    LDL change -26% 
    HDL change +5% 

    Patients

    Patients men aged 45-64 yr with no history of myocardial infarction and with raised plasma cholesterol levels (LDL cholesterol of at least 155 mg/dL, total cholesterol of at least 252 mg/dL)
    Inclusion criteria fasting LDL cholesterol level of at least 155 mg per deciliter during the second and third visits, with at least one value of 174 mg per deciliter or above (4.5 mmol per liter) and one value of 232 mg per deciliter or below (6.0 mmol per liter); no serious ECG abnormalities according to Minnesota code 1 (pathologic Q waves), 4-1, 5-1, or 7-1-1 or arrhythmia such as atrial fibrillation; and no history of myocardial infarction or other serious illness, although men with stable angina who had not been hospitalized within the previous 12 months were eligible
    Baseline characteristics
    Age (mean), yrs 55 yr 
    Women (%)
    prior MI or CHD (%) 5% 
    Total cholesterol (mmol/l) 7.1 mmol/L 
    LDL (mmol/l) 4.99 mmol/L 
    HDL (mmol/l) 1.14 mmol/L 
    Triglycerides (mg/dl) 163 
    Diabetes(%) 1% 
    BMI (kg/m2) 26 
    Stroke history NA 
    LV hypertrophy NA 
    History of hypertension (%) 15% 

    Method and design

    Randomized effectives 3302 / 3293 (studied vs. control)
    Design Parallel groups
    Blinding double blind
    Follow-up duration 4.9 years
    Number of centre multicenter
    Geographic area Scotland
    Hypothesis Superiority
    Primary endpoint coronary events (CHD death, MI)


    Results

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

    Coronary event

    174 / 3302
    248 / 3293
    0,70 [0,58;0,84]

    All cause death

    106 / 3302
    136 / 3293
    0,78 [0,61;1,00]

    Cardiovascular death

    50 / 3302
    73 / 3293
    0,68 [0,48;0,98]

    cardiovascular events

    145 / 3302
    248 / 3293
    0,58 [0,48;0,71]

    Fatal stroke

    6 / 3302
    4 / 3293
    classic 1,50 [0,42;5,30]

    new-onset diabetes

    75 / 2999
    93 / 2975
    0,80 [0,59;1,08]

    Coronary death

    38 / 3302
    52 / 3293
    0,73 [0,48;1,10]

    stroke (fatal and non fatal)

    46 / 3302
    51 / 3293
    0,90 [0,61;1,34]

    Non fatal MI

    143 / 3302
    204 / 3293
    0,70 [0,57;0,86]

    Death from cancer

    44 / 3302
    49 / 3293
    0,90 [0,60;1,34]

    Coronary death and non fatal MI

    174 / 3302
    248 / 3293
    0,70 [0,58;0,84]

    cardiac death

    38 / 3302
    52 / 3293
    0,73 [0,48;1,10]

    non cardiovascular death

    68 / 3302
    83 / 3293
    0,82 [0,60;1,12]
    0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial
    Ref
    Studied treat. Control treat.
    Coronary event 174 / 3302 (5,3%) 248 / 3293 (7,5%) 0,70 [0,58;0,84]  
    All cause death 106 / 3302 (3,2%) 136 / 3293 (4,1%) 0,78 [0,61;1,00]  
    Cardiovascular death 50 / 3302 (1,5%) 73 / 3293 (2,2%) 0,68 [0,48;0,98]  
    cardiovascular events 145 / 3302 (4,4%) 248 / 3293 (7,5%) 0,58 [0,48;0,71]  
    Fatal stroke 6 / 3302 (0,2%) 4 / 3293 (0,1%) 1,50 [0,42;5,30]  
    new-onset diabetes 75 / 2999 (2,5%) 93 / 2975 (3,1%) 0,80 [0,59;1,08] sub group  12095
    Coronary death 38 / 3302 (1,2%) 52 / 3293 (1,6%) 0,73 [0,48;1,10]  
    stroke (fatal and non fatal) 46 / 3302 (1,4%) 51 / 3293 (1,5%) 0,90 [0,61;1,34]  
    Non fatal MI 143 / 3302 (4,3%) 204 / 3293 (6,2%) 0,70 [0,57;0,86]  
    Death from cancer 44 / 3302 (1,3%) 49 / 3293 (1,5%) 0,90 [0,60;1,34]  
    Coronary death and non fatal MI 174 / 3302 (5,3%) 248 / 3293 (7,5%) 0,70 [0,58;0,84]  
    cardiac death 38 / 3302 (1,2%) 52 / 3293 (1,6%) 0,73 [0,48;1,10]  
    non cardiovascular death 68 / 3302 (2,1%) 83 / 3293 (2,5%) 0,82 [0,60;1,12]  
    The primary endpoint (if exists) appears in blod characters
    Reference(s) used for data extraction:
  • 12095: Sattar N, Preiss D, Murray HM, Welsh P, Buckley BM, de Craen AJ, Seshasai SR, McMurray JJ, Freeman DJ, Jukema JW, Macfarlane PW, Packard CJ, Stott DJ, Westendorp RG, Shepherd J, Davis BR, Pressel SL, Marchioli R, Marfisi RM, Maggioni AP, Tavazzi L, TognonStatins and risk of incident diabetes: a collaborative meta-analysis of randomised statin trials.Lancet 2010 Feb 27;375:735-742
  • 0:

  • Endpoint studied treat. control treat. mean diff

    Absolute risk reduction
    Endpoint Events rate Absolute risk
    reduction (ARR)
    Studied treat. Control treat.
    Coronary event 5,27% 7,53% -22,6‰
    All cause death 3,21% 4,13% -9,2‰
    Cardiovascular death 1,51% 2,22% -7,0‰
    cardiovascular events 4,39% 7,53% -31,4‰
    Fatal stroke 1,82‰ 1,21‰ 0,6‰
    new-onset diabetes 2,50% 3,13% -6,3‰
    Coronary death 1,15% 1,58% -4,3‰
    stroke (fatal and non fatal) 1,39% 1,55% -1,6‰
    Non fatal MI 4,33% 6,19% -18,6‰
    Death from cancer 1,33% 1,49% -1,6‰
    Coronary death and non fatal MI 5,27% 7,53% -22,6‰
    cardiac death 1,15% 1,58% -4,3‰
    non cardiovascular death 2,06% 2,52% -4,6‰

    Meta-analysis of all similar trials:

    cholesterol lowering intervention in cardiovascular prevention for all chronical situations

    cholesterol lowering intervention in cardiovascular prevention for primary prevention

    cholesterol lowering intervention in cardiovascular prevention for patients with LDL elevation and without CHD



    Reference(s)

    Trials register # NA
    • Shepherd J, Cobbe SM, Ford I, Isles CG, Lorimer AR, MacFarlane PW, McKillop JH, Packard CJ,. Prevention of coronary heart disease with pravastatin in men with hypercholesterolemia. West of Scotland Coronary Prevention Study Group.. N Engl J Med 1995; 333:1301-7
      Pubmed | Hubmed | Fulltext
    • . A coronary primary prevention study of Scottish men aged 45-64 years: trial design. The West of Scotland Coronary Prevention Study Group.. J Clin Epidemiol 1992;45:849-60
      Pubmed | Hubmed | Fulltext

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