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Systematic review and meta-analysis

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

cardiovascular prevention - CEPT inhibition - all type of patients

cardiovascular prevention - HDL increasing drugs - all type of patients


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See also:

  • All cardiovascular prevention clinical trials
  • All clinical trials of HDL increasing drugs
  • All clinical trials of anacetrapib
    		•  
     DEFINE study, 2010 TRC11409 
    [NCT00685776] download pdf: anacetrapib | CEPT inhibition for cardiovascular prevention

    Treatments

    Studied treatment anacetrapib 100mg fr 18 months
    Control treatment placebo

    Patients

    Patients patients with coronary heart disease or at high risk for coronary heart disease
    Inclusion criteria between 18 and 80 years of age, prior known coronary heart disease or at high risk for coronary heart disease (Framingham Risk score of >20% per 10 years, as defined by the National Cholesterol Education Program Adult Treatment Panel III) and LDL cholesterol level between 50 and 100 mg per deciliter (1.3 and 2.6 mmol per liter) while taking a statin with or without other lipid-modifying medications, HDL cholesterol level of less than 60 mg per deciliter (1.6 mmol per liter), and a triglyceride level of 400 mg per deciliter (4.5 mmol per liter) or less
    Exclusion criteria severe chronic heart failure, uncontrolled hypertension, or cardiac arrhythmias; within the previous 3 months: myocardial infarction, percutaneous coronary intervention, coronary-artery bypass grafting, unstable angina, or stroke; active or chronic hepatobiliary or hepatic disease or severe renal impairment; or treatment with warfarin or potent CYP3A4 inhibitors or inducers

    Method and design

    Randomized effectives 811 / 812 (studied vs. control)
    Design Parallel groups
    Blinding double-blind
    Number of centre 153
    Geographic area 20 countries
    Hypothesis Superiority
    Primary endpoint percent change from baseline in LDL cholesterol at 24 weeks


    Results



    Endpoints and data reported in the trial's publication(s)

    Endpoint Events (%) Relative Risk 95% CI
    Studied treat. Control treat.
    Prespecified, adjudicated cardiovascular safety end point 16 / 811 (2,0%) 21 / 812 (2,6%) 0,76 [0,40;1,45]
    Death from cardiovascular causes 4 / 811 (0,5%) 1 / 812 (0,1%) 4,00 [0,45;35,76]
    Nonfatal myocardial infarction 6 / 811 (0,7%) 9 / 812 (1,1%) 0,67 [0,24;1,87]
    Hospitalization for unstable angina 1 / 811 (0,1%) 6 / 812 (0,7%) 0,17 [0,02;1,38]
    Nonfatal stroke 5 / 811 (0,6%) 5 / 812 (0,6%) 1,00 [0,29;3,45]
    Death from any cause 11 / 811 (1,4%) 8 / 812 (1,0%) 1,38 [0,56;3,40]
    Heart failure 3 / 811 (0,4%) 4 / 812 (0,5%) 0,75 [0,17;3,34]
    Revascularization 8 / 811 (1,0%) 28 / 812 (3,4%) 0,29 [0,13;0,62]
    PCI 6 / 811 (0,7%) 25 / 812 (3,1%) 0,24 [0,10;0,58]
    CABG 2 / 811 (0,2%) 3 / 812 (0,4%) 0,67 [0,11;3,98]

    Endpoints used by the meta-analysis and data retained for this trial

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

    cardiovascular events

    16 / 811
         21 / 812
         0,76 [0,40;1,45]     0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial    		 Ref
    Studied treat. Control treat.
    cardiovascular events 16 / 811 (2,0%) 21 / 812 (2,6%) 0,76 [0,40;1,45] Prespecified adjudicated cardiovascular events  
    The primary endpoint (if exists) appears in blod characters
    Reference(s) used for data extraction:

    Endpoint studied treat. control treat. mean diff

    Absolute risk reduction (for a follow-up of )
    Endpoint Events rate Absolute risk
    reduction (ARR)
    Studied treat. Control treat.
    cardiovascular events 1,97% 2,59% -0,61%

    Meta-analysis of all similar trials:

    CEPT inhibition in cardiovascular prevention for all type of patients

    HDL increasing drugs in cardiovascular prevention for all type of patients



    Reference(s)

    TrialResults-center ID TRC11409
    Trials register # NCT00685776
    • Cannon CP, Shah S, Dansky HM, Davidson M, Brinton EA, Gotto AM, Stepanavage M, Liu SX, Gibbons P, Ashraf TB, Zafarino J, Mitchel Y, Barter P. Safety of Anacetrapib in Patients with or at High Risk for Coronary Heart Disease.. N Engl J Med 2010 Nov 17;: - 10.1056/NEJMoa1009744
      Pubmed | Hubmed | Fulltext

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