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See also:

  • All cardiovascular prevention clinical trials
  • All clinical trials of cholesterol lowering intervention
  • All clinical trials of pravastatin
  •  
     MEGA study, 2006 TRC4974 
    [NCT00211705] download pdf: pravastatin | cholesterol lowering intervention for cardiovascular prevention

    Treatments

    Studied treatment pravastatin 10 mg daily (20 mg per day if the total cholesterolconcentration did not decrease to 5·69 mmol/L or less)
    Control treatment control
    Concomittant treatment diet
    Treatments description
    total cholesterol change -11% (at 1 year) 
    LDL change -17% (at 1 year) 
    HDL change +4% (at 1 year) 

    Patients

    Patients patients with hypercholesterolaemia (total cholesterol 5·69–6·98 mmol/L) and no history of coronary heart disease or stroke
    Inclusion criteria men and postmenopausal women; aged 40–70 years; bodyweight of 40 kg or more; hypercholesterolaemia with a total cholesterol concentration between 5·69–6·98 mmol/L
    Exclusion criteria familial hypercholesterolaemia; history of coronary heart disease or stroke;
    Baseline characteristics
    Age (mean), yrs 58.3 y 
    Women (%) 68.5% 
    Total cholesterol (mmol/l) 6.27 
    LDL (mmol/l) 4.05 
    HDL (mmol/l) 1.49 
    Triglycerides (mg/dl) 1.44 
    Diabetes(%) 21% 
    BMI (kg/m2) 23.8  
    History of hypertension (%) 42% 

    Method and design

    Randomized effectives 3866 / 3966 (studied vs. control)
    Design Parallel groups
    Blinding open, blind assessment
    Follow-up duration 5.3 y
    Geographic area Japan
    Hypothesis Superiority
    Primary endpoint CHD events

    Remarks / Comments

    ,



    Results

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

    Coronary event

    66 / 3866
    101 / 3966
    0,67 [0,49;0,91]

    All cause death

    55 / 3866
    79 / 3966
    0,71 [0,51;1,00]

    Cardiovascular death

    11 / 3866
    18 / 3966
    0,63 [0,30;1,33]

    cardiovascular events

    125 / 3866
    172 / 3966
    0,75 [0,59;0,93]

    Haemmorhagic stroke

    14 / 3866
    16 / 3966
    0,90 [0,44;1,84]

    new-onset diabetes

    172 / 3013
    164 / 3073
    1,07 [0,87;1,32]

    Coronary death

    17 / 3866
    33 / 3966
    0,53 [0,29;0,95]

    stroke (fatal and non fatal)

    50 / 3866
    62 / 3966
    0,83 [0,57;1,20]

    MACE

    98 / 3866
    144 / 3966
    0,70 [0,54;0,90]

    Non fatal MI

    16 / 3866
    30 / 3966
    0,55 [0,30;1,00]

    non cardiovascular death

    44 / 3866
    61 / 3966
    0,74 [0,50;1,09]
    0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial
    Ref
    Studied treat. Control treat.
    Coronary event 66 / 3866 (1,7%) 101 / 3966 (2,5%) 0,67 [0,49;0,91]  
    All cause death 55 / 3866 (1,4%) 79 / 3966 (2,0%) 0,71 [0,51;1,00]  
    Cardiovascular death 11 / 3866 (0,3%) 18 / 3966 (0,5%) 0,63 [0,30;1,33]  
    cardiovascular events 125 / 3866 (3,2%) 172 / 3966 (4,3%) 0,75 [0,59;0,93]  
    Haemmorhagic stroke 14 / 3866 (0,4%) 16 / 3966 (0,4%) 0,90 [0,44;1,84]  
    new-onset diabetes 172 / 3013 (5,7%) 164 / 3073 (5,3%) 1,07 [0,87;1,32] sub group  12095
    Coronary death 17 / 3866 (0,4%) 33 / 3966 (0,8%) 0,53 [0,29;0,95] fatal and non fatal MI 
    stroke (fatal and non fatal) 50 / 3866 (1,3%) 62 / 3966 (1,6%) 0,83 [0,57;1,20]  
    MACE 98 / 3866 (2,5%) 144 / 3966 (3,6%) 0,70 [0,54;0,90]  
    Non fatal MI 16 / 3866 (0,4%) 30 / 3966 (0,8%) 0,55 [0,30;1,00]   4115
    non cardiovascular death 44 / 3866 (1,1%) 61 / 3966 (1,5%) 0,74 [0,50;1,09]  
    The primary endpoint (if exists) appears in blod characters
    Reference(s) used for data extraction:
  • 4115: Nakamura H, Arakawa K, Itakura H, Kitabatake A, Goto Y, Toyota T, Nakaya N, Nishimoto S, Muranaka M, Yamamoto A, Mizuno K, Ohashi YPrimary prevention of cardiovascular disease with pravastatin in Japan (MEGA Study): a prospective randomised controlled trial.Lancet 2006 Sep 30;368:1155-63
  • 0:
  • 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

  • Endpoint studied treat. control treat. mean diff

    Absolute risk reduction (for a follow-up of 5.3 y)
    Endpoint Events rate Absolute risk
    reduction (ARR)
    Studied treat. Control treat.
    Coronary event 1,71% 2,55% -0,84%
    All cause death 1,42% 1,99% -0,57%
    Cardiovascular death 2,85‰ 4,54‰ -0,17%
    cardiovascular events 3,23% 4,34% -1,10%
    Haemmorhagic stroke 3,62‰ 4,03‰ -0,04%
    new-onset diabetes 5,71% 5,34% 0,37%
    Coronary death 4,40‰ 8,32‰ -0,39%
    stroke (fatal and non fatal) 1,29% 1,56% -0,27%
    MACE 2,53% 3,63% -1,10%
    Non fatal MI 4,14‰ 7,56‰ -0,34%
    non cardiovascular death 1,14% 1,54% -0,40%

    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 TRC4974
    Trials register # NCT00211705
    • Nakamura H, Arakawa K, Itakura H, Kitabatake A, Goto Y, Toyota T, Nakaya N, Nishimoto S, Muranaka M, Yamamoto A, Mizuno K, Ohashi Y. Primary prevention of cardiovascular disease with pravastatin in Japan (MEGA Study): a prospective randomised controlled trial.. Lancet 2006 Sep 30;368:1155-63
      Pubmed | Hubmed | Fulltext
    • Nakamura H. [Primary prevention trial by lowering hyperlipidemia on the cardiovascular disease (MEGA Study)]. Nippon Ronen Igakkai Zasshi 2009;46:18-21
      Pubmed | Hubmed | Fulltext

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