The purpose of this study is to evaluate the effect of ezetimibe coadministered with simvastatin compared with simvastatin alone when administered for 12 weeks on endothelial function as assessed by brachial artery reactivity testing (BART) using high-frequency ultrasound to image the brachial artery vasomotor response to a flow-mediated stimulus (high-shear stress) in subjects with high cholesterol. The secondary objectives include evaluation of nitroglycerin-induced vasodilation. In addition, lipid parameters (low-density-lipoprotein cholesterol \[LDL-C\], high-density-lipoprotein cholesterol \[HDL-C\], triglycerides \[TG\], total cholesterol \[TC\]) and C reactive protein (CRP) will be assessed by treatment group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
28
oral tablet of ezetimibe 10 mg plus simvastatin 20 mg once daily in the evening for 12 weeks
oral simvastatin 20 mg once daily in the evening for 12 weeks
oral placebo once daily in the evening for 12 weeks
Change from baseline to endpoint in flow-mediated vasodilation: percent change in the mean diameter between 1-minute, post-cuff release diameter and image obtained prior to cuff application.
Time frame: Week 12
Change from baseline to endpoint in NTG-induced vasodilation: percent change in the diameter between the post-NTG and pre-NTG diameters.
Time frame: Week 12
Changes from baseline to endpoint in LDL-C, HDL-C, TG, TC, and CRP.
Time frame: Week 12
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