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See also:

  • All cardiovascular prevention clinical trials
  • All clinical trials of cholesterol lowering intervention
  • All clinical trials of simvastatin high dose
    		•  
     SEARCH study, 2010 TRC8855 
    [NCT00124072] download pdf: simvastatin high dose | cholesterol lowering intervention for cardiovascular prevention

    Treatments

    Studied treatment simvastatin 80 mg daily
    Control treatment simvastatin 20mg daily
    Remarks factorial design with folic acid and vitamin B12
    Treatments description
    LDL change 0.39 mmol/l, 16% (at 1 year) 

    Patients

    Patients MI survivors
    Inclusion criteria previous MI; age between 18-80y, current use or clear indication for statin; no hospitalization in previous 3 months for MI, unstable angina or coronary revascularisation (and none planned in next 3 months); total cholesterol concentration of at least 3�5 mmol/L if already on a statin or 4�5 mmol/L if not
    Baseline characteristics
    Age (mean), yrs 64y 
    Women (%) 17% 
    Total cholesterol (mmol/l) 4.2 mmol/l 
    LDL (mmol/l) 2.5 mmol/l 
    HDL (mmol/l) 1.0 mmol/l 
    Triglycerides (mg/dl) 168 mg/dl 

    Method and design

    Randomized effectives 6031 / 6033 (studied vs. control)
    Design Parallel groups
    Follow-up duration 6.7 years (mean)
    Hypothesis Superiority
    Primary endpoint coronary death, myocardial infarction, stroke, or arterial revascularisation


    Results

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

    Coronary event

    1189 / 6031
         1225 / 6033
         0,97 [0,90;1,04]

    All cause death

    964 / 6031
         969 / 6033
         1,00 [0,92;1,08]

    Cardiovascular death

    557 / 6031
         561 / 6033
         0,99 [0,89;1,11]

    cardiovascular events

    1477 / 6031
         1553 / 6033
         0,95 [0,89;1,01]

    Fatal stroke

    57 / 6031
         67 / 6033
         0,85 [0,60;1,21]

    Coronary death

    447 / 6031
         438 / 6033
         1,02 [0,90;1,16]

    stroke (fatal and non fatal)

    255 / 6031
         279 / 6033
         0,91 [0,77;1,08]

    MACE

    1477 / 6031
         1553 / 6033
         0,95 [0,89;1,01]

    Non fatal MI

    397 / 6031
         463 / 6033
         0,86 [0,75;0,98]

    Rhabdomyolysis

    53 / 6031
         3 / 6033
         classic 17,67 [5,53;56,52]

    Death from cancer

    245 / 6031
         266 / 6033
         0,92 [0,78;1,09]

    cardiac death

    447 / 6031
         438 / 6033
         1,02 [0,90;1,16]

    non cardiovascular death

    407 / 6031
         408 / 6033
         1,00 [0,87;1,14]     0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial    		 Ref
    Studied treat. Control treat.
    Coronary event 1189 / 6031 (19,7%) 1225 / 6033 (20,3%) 0,97 [0,90;1,04] CHD death, MI, revasc.  0
    All cause death 964 / 6031 (16,0%) 969 / 6033 (16,1%) 1,00 [0,92;1,08]   0
    Cardiovascular death 557 / 6031 (9,2%) 561 / 6033 (9,3%) 0,99 [0,89;1,11] all vascular death  0
    cardiovascular events 1477 / 6031 (24,5%) 1553 / 6033 (25,7%) 0,95 [0,89;1,01] coronary death, myocardial infarction, stroke, or arterial revascularisation  0
    Fatal stroke 57 / 6031 (0,9%) 67 / 6033 (1,1%) 0,85 [0,60;1,21]  
    Coronary death 447 / 6031 (7,4%) 438 / 6033 (7,3%) 1,02 [0,90;1,16] CHD death  0
    stroke (fatal and non fatal) 255 / 6031 (4,2%) 279 / 6033 (4,6%) 0,91 [0,77;1,08]   0
    MACE 1477 / 6031 (24,5%) 1553 / 6033 (25,7%) 0,95 [0,89;1,01] coronary ev + stroke  0
    Non fatal MI 397 / 6031 (6,6%) 463 / 6033 (7,7%) 0,86 [0,75;0,98]   0
    Rhabdomyolysis 53 / 6031 (0,9%) 3 / 6033 (0,0%) 17,67 [5,53;56,52] CK>10xULN  0
    Death from cancer 245 / 6031 (4,1%) 266 / 6033 (4,4%) 0,92 [0,78;1,09]   0
    cardiac death 447 / 6031 (7,4%) 438 / 6033 (7,3%) 1,02 [0,90;1,16] CHD death  0
    non cardiovascular death 407 / 6031 (6,7%) 408 / 6033 (6,8%) 1,00 [0,87;1,14]   0
    The primary endpoint (if exists) appears in blod characters
    Reference(s) used for data extraction:
  • 0:

    • Endpoint studied treat. control treat. mean diff

    Absolute risk reduction (for a follow-up of 6.7 years (mean))
    Endpoint Events rate Absolute risk
    reduction (ARR)
    Studied treat. Control treat.
    Coronary event 19,71% 20,30% -0,59%
    All cause death 15,98% 16,06% -0,08%
    Cardiovascular death 9,24% 9,30% -0,06%
    cardiovascular events 24,49% 25,74% -1,25%
    Fatal stroke 9,45‰ 1,11% -0,17%
    Coronary death 7,41% 7,26% 0,15%
    stroke (fatal and non fatal) 4,23% 4,62% -0,40%
    MACE 24,49% 25,74% -1,25%
    Non fatal MI 6,58% 7,67% -1,09%
    Rhabdomyolysis 8,79‰ 0,50‰ 0,83%
    Death from cancer 4,06% 4,41% -0,35%
    cardiac death 7,41% 7,26% 0,15%
    non cardiovascular death 6,75% 6,76% -0,01%

    Meta-analysis of all similar trials:

    cholesterol lowering intervention in cardiovascular prevention for patients with prior MI or with CHD

    cholesterol lowering intervention in cardiovascular prevention for all chronical situations



    Reference(s)

    TrialResults-center ID TRC8855
    Trials register # NCT00124072
    Study web site link http://directnews.americanheart.org/extras/pdfs/search_slides.pdf
    • Study Of The Effectiveness Of Additional Reductions In Cholesterol And Homocysteine Search Collaborative Group. Intensive lowering of LDL cholesterol with 80 mg versus 20 mg simvastatin daily in 12?064 survivors of myocardial infarction: a double-blind randomised trial.. Lancet 2010 Nov 8;: - 10.1016/S0140-6736(10)60310-8
      Pubmed | Hubmed | Fulltext

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