Effects of Statin and Ezetimibe Association on Kinetics of Artificial Chilomicrons
Status:
Completed
Trial end date:
2010-01-01
Target enrollment:
Participant gender:
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.