Effects of Statin and Ezetimibe Association on Kinetics of Artificial Chilomicrons
Condition: Coronary Heart Disease
MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia
Intervention: Simvastatin 20mg plus ezetimibe 10mg; ezetimibe; simvastatin 20mg; Simvastatin 80mg
Intervention description: simvastatin 20mg plus ezetimibe 10mg once a day for 6 week.; ezetimiba 10mg once a day; simvastatin 20mg once a day; simvastatin 20mg for 6week and then simvastatin 80mg for the next 6week.
Intervention MeSH terms: Simvastatin; Ezetimibe
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 30 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: artificial chilomicrons kinetics; ezetimibe plus statin; lipid lowering therapy

Summary:

      Effects of statin and ezetimibe association on kinetics of artificial chylomicrons in men
      with stable coronary heart disease (CHD).

      Background:

      The rate (kinetics) of chylomicrons removal from circulation have been correlated with the
      incidence and severity of atherosclerotic lesions; a number of studies demonstrated lower
      plasmatic clearance of chylomicrons in patients with CHD compared to patients without this
      condition. It was also demonstrated a correlation among LDL-C levels and removal of
      chylomicrons remnants by a technique employing artificial chylomicrons.

      The investigators also know that higher doses of more potent statins are more effective in
      chylomicrons removal than lower doses or less potent statins; nevertheless, the effect of the
      isolated use of statin has not been completely studied up to now.

      Study design:

      The investigators propose to study 26 outpatients volunteers with chronic CHD, followed at
      the Heart Institute - INCOR - of the School of Medicine, University of São Paulo.

      Following a period of six weeks of washout from any cholesterol reducer, the kinetics of
      chylomicrons removal by a technique of emulsion of radiolabeled artificial chylomicrons will
      be evaluated. Lipid fractions, hepatic enzymes and CK will be measured. Initially patients
      will be randomly allocated to receive simvastatin 20 mg /day (n= 13) or ezetimibe 10 mg/day
      (n=13) for six weeks. At the end of this period, kinetics of chylomicrons removal and
      laboratorial measurements will be repeated (Period 1).

      In the next period (Period 2) patients will receive simvastatin 20 mg/ ezetimibe 10 mg (n=13)
      or simvastatin 80 mg (n=13) for additional six weeks; at the end of this period, the
      evaluations will be repeated (third and last evaluation).

      The aim of this study is to further understand chylomicrons metabolism in patients with
      chronic coronary disease receiving cholesterol reducers at different dosage regimes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Stable coronary heart disease.

        Exclusion Criteria:

          -  Renal and Liver failure

          -  Hypothyroidism

          -  Diabetes mellitus

          -  Neoplasia

          -  Heart failure.