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Systematic review and meta-analysis

This trial is included in the following systematic reviews and meta-analyses:

cardiovascular prevention - cholesterol lowering intervention - primary prevention


Related trials

JUPITER, 2008 - rosuvastatin vs placebo

ASPEN (primary prevention sub group), 2006 - atorvastatin vs placebo

ASPEN, 2006 - atorvastatin vs placebo

MEGA, 2006 - pravastatin vs control

HYRIM, 2005 - fluvastatin vs placebo

PHYLLIS, 2004 - pravastatin vs placebo

CARDS, 2004 - atorvastatin vs placebo

ALERT, 2003 - fluvastatin vs placebo

ASCOT, 2003 - atorvastatin vs placebo

Mohler, 2003 - atorvastatin vs placebo

HPS (primary prevention sub group), 2003 - simvastatin vs placebo

FAST Fukuoka pravastatin, 2002 - pravastatin vs control

PROSPER (primary prevention subgroup), 2002 - pravastatin vs placebo

ALLHAT, 2002 - pravastatin vs usual care

BCAPS, 2001 - fluvastatin vs placebo

KLIS, 2000 - pravastatin vs usual care

AFCAPS/TexCAPS, 1998 - lovastatin vs placebo

CAIUS, 1996 - pravastatin vs placebo

WOSCOPS, 1995 - pravastatin vs placebo

KAPS, 1995 - pravastatin vs placebo

ACAPS, 1994 - lovastatin vs placebo

PMSG, 1993 - pravastatin vs placebo



See also:

  • All cardiovascular prevention clinical trials
  • All clinical trials of cholesterol lowering intervention
  • All clinical trials of atorvastatin
  •  
     ASPEN (primary prevention sub group) study, 2006 TRC9788 
    download pdf: atorvastatin | cholesterol lowering intervention for cardiovascular prevention

    Treatments

    Studied treatment atorvastatin 10mg
    Control treatment placebo
    Treatments description
    total cholesterol change -19.8% 
    LDL change -30.5% 
    HDL change +1.9% 

    Patients

    Patients subjects with type 2 diabetes and LDL cholesterol levels below contemporary guideline targets; primary prevention subgroup
    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 (range 40-75) 
    Women (%) 38% 
    prior MI or CHD (%) 0% 
    Total cholesterol (mmol/l) 5.0 mmol/l 
    LDL (mmol/l) 3.0 mmol/l 
    HDL (mmol/l) 1.2 mmol/L 
    Triglycerides (mg/dl) 1.6 mmol/l 
    Diabetes(%) 100% 
    BMI (kg/m2) 28.9 
    Stroke history 5% 
    History of hypertension (%) 52% 

    Method and design

    Randomized effectives 959 / 947 (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
    Remarks

    Remarks / Comments



    Results

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

    Coronary event

    100 / 959
    102 / 946
    0,97 [0,75;1,26]

    All cause death

    44 / 959
    41 / 946
    1,06 [0,70;1,60]

    Cardiovascular death

    24 / 959
    19 / 946
    classic 1,25 [0,69;2,26]

    cardiovascular events

    100 / 959
    102 / 946
    0,97 [0,75;1,26]

    stroke (fatal and non fatal)

    27 / 959
    29 / 946
    0,92 [0,55;1,54]

    non cardiovascular death

    20 / 959
    22 / 946
    0,90 [0,49;1,63]
    0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial
    Ref
    Studied treat. Control treat.
    Coronary event 100 / 959 (10,4%) 102 / 946 (10,8%) 0,97 [0,75;1,26]   11051
    All cause death 44 / 959 (4,6%) 41 / 946 (4,3%) 1,06 [0,70;1,60]   11048
    Cardiovascular death 24 / 959 (2,5%) 19 / 946 (2,0%) 1,25 [0,69;2,26]   11051
    cardiovascular events 100 / 959 (10,4%) 102 / 946 (10,8%) 0,97 [0,75;1,26]   11051
    stroke (fatal and non fatal) 27 / 959 (2,8%) 29 / 946 (3,1%) 0,92 [0,55;1,54]   11048
    non cardiovascular death 20 / 959 (2,1%) 22 / 946 (2,3%) 0,90 [0,49;1,63]   11051
    The primary endpoint (if exists) appears in blod characters
    Reference(s) used for data extraction:
  • 11048: Brugts JJ, Yetgin T, Hoeks SE, Gotto AM, Shepherd J, Westendorp RG, de Craen AJ, Knopp RH, Nakamura H, Ridker P, van Domburg R, Deckers JWThe benefits of statins in people without established cardiovascular disease but with cardiovascular risk factors: meta-analysis of randomised controlled trials.BMJ 2009 Jun 30;338:b2376
  • 11051: 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
  • 0:

  • 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 10,43% 10,78% -0,35%
    All cause death 4,59% 4,33% 0,25%
    Cardiovascular death 2,50% 2,01% 0,49%
    cardiovascular events 10,43% 10,78% -0,35%
    stroke (fatal and non fatal) 2,82% 3,07% -0,25%
    non cardiovascular death 2,09% 2,33% -0,24%

    Meta-analysis of all similar trials:

    cholesterol lowering intervention in cardiovascular prevention for primary prevention



    Reference(s)

    TrialResults-center ID TRC9788
    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 - 10.2337/dc05-2415
      Pubmed | Hubmed | Fulltext

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