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See also:

  • All cardiovascular prevention clinical trials
  • All clinical trials of cholesterol lowering intervention
  • All clinical trials of atorvastatin
  •  
     ASPEN study, 2006 TRC6716 
    download pdf: atorvastatin | cholesterol lowering intervention for cardiovascular prevention

    Treatments

    Studied treatment atorvastatin 10mg
    Control treatment placebo
    placebo
    Treatments description
    total cholesterol change -18% 
    LDL change -29% 
    HDL change +2.35% 

    Patients

    Patients subjects with type 2 diabetes and LDL cholesterol levels below contemporaryguideline targets
    Inclusion criteria Male and female subjects, aged 40–75 years, type 2 diabetes by the World; Health Organization definition (17) 3 years before screening. LDL cholesterol criteria were 1) LDL cholesterol <=140 mg/dl (3.6 mmol/l) if subjects had documented myocardial infarction or an interventional procedure >=3 months before screening or 2) LDL cholesterol <=160 mg/dl (4.1 mmol/l) if not. Triglyceride levels were required to be >=600 mg/dl (6.8 mmol/l) at all visits.
    Exclusion criteria diabetes; myocardial infarction, interventional procedure, or episodes of unstable angina3 months before screening; HbA1c (A1C) 10%; active liver disease or hepatic dysfunction (aspartate or alanine aminotransferase levels 1.5 the upper limit of normal); severe renal dysfunction or nephrotic syndrome; congestive heart failure treated with digoxin; creatine phosphokinase 3 the upper limit of normal; blood pressure 160/100 mmHg; BMI35 kg/m2; abuse of alcohol and/or drugs; hypersensitivity to the study medication;placebo run-in compliance rate 80%; current or planned pregnancy; or use of excluded medications
    Baseline characteristics
    Age (mean), yrs 61y 
    Women (%) 34% 
    prior MI or CHD (%) 17% 
    Total cholesterol (mmol/l) 194 mg/dl 
    LDL (mmol/l) 113 md/dl 
    HDL (mmol/l) 47 mg/dl 
    Triglycerides (mg/dl) 146 mg/dl 
    Diabetes(%) 100% 
    BMI (kg/m2) 28.8 
    Stroke history 5% 
    History of hypertension (%) 55% 

    Method and design

    Randomized effectives 1211 / 1199 (studied vs. control)
    Design Parallel groups
    Blinding double blind
    Follow-up duration 4 year
    Number of centre 70
    Geographic area 14 countries
    Hypothesis Superiority
    Primary endpoint cardiovascular events


    Results

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

    Coronary event

    49 / 1211
    66 / 1199
    0,74 [0,51;1,05]

    Cardiovascular death

    38 / 1211
    37 / 1199
    1,02 [0,65;1,59]

    cardiovascular events

    166 / 1211
    180 / 1199
    0,91 [0,75;1,11]

    stroke (fatal and non fatal)

    34 / 1211
    38 / 1199
    0,89 [0,56;1,40]

    MACE

    166 / 1211
    180 / 1199
    0,91 [0,75;1,11]
    0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial
    Ref
    Studied treat. Control treat.
    Coronary event 49 / 1211 (4,0%) 66 / 1199 (5,5%) 0,74 [0,51;1,05] fatal non fatal MI 
    Cardiovascular death 38 / 1211 (3,1%) 37 / 1199 (3,1%) 1,02 [0,65;1,59]  
    cardiovascular events 166 / 1211 (13,7%) 180 / 1199 (15,0%) 0,91 [0,75;1,11]   6911
    stroke (fatal and non fatal) 34 / 1211 (2,8%) 38 / 1199 (3,2%) 0,89 [0,56;1,40]  
    MACE 166 / 1211 (13,7%) 180 / 1199 (15,0%) 0,91 [0,75;1,11]  
    The primary endpoint (if exists) appears in blod characters
    Reference(s) used for data extraction:
  • 0:
  • 6911: Knopp RH, d'Emden M, Smilde JG, Pocock SJEfficacy and safety of atorvastatin in the prevention of cardiovascular end points in subjects with type 2 diabetes: the Atorvastatin Study for Prevention of Coronary Heart Disease Endpoints in non-insulin-dependent diabetes mellitus (ASPEN).Diabetes Care 2006;29:1478-85

  • Endpoint studied treat. control treat. mean diff

    Absolute risk reduction (for a follow-up of 4 year)
    Endpoint Events rate Absolute risk
    reduction (ARR)
    Studied treat. Control treat.
    Coronary event 4,05% 5,50% -1,46%
    Cardiovascular death 3,14% 3,09% 0,05%
    cardiovascular events 13,71% 15,01% -1,30%
    stroke (fatal and non fatal) 2,81% 3,17% -0,36%
    MACE 13,71% 15,01% -1,30%

    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



    Reference(s)

    TrialResults-center ID TRC6716
    Trials register # NA
    • Knopp RH, d'Emden M, Smilde JG, Pocock SJ. Efficacy and safety of atorvastatin in the prevention of cardiovascular end points in subjects with type 2 diabetes: the Atorvastatin Study for Prevention of Coronary Heart Disease Endpoints in non-insulin-dependent diabetes mellitus (ASPEN).. Diabetes Care 2006;29:1478-85
      Pubmed | Hubmed | Fulltext

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