Title of article :
Efficacy and Safety of Torcetrapib, a Novel Cholesteryl Ester Transfer Protein Inhibitor, in Individuals With Below-Average High-Density Lipoprotein Cholesterol Levels Original Research Article
Author/Authors :
Michael H. Davidson، نويسنده , , James M. McKenney، نويسنده , , Charles L. Shear، نويسنده , , James H. Revkin، نويسنده ,
Issue Information :
روزنامه با شماره پیاپی سال 2006
Abstract :
Objectives
This study was designed to evaluate the efficacy and safety of torcetrapib, a cholesteryl ester transfer protein (CETP) inhibitor, in subjects with low high-density lipoprotein cholesterol (HDL-C) levels.
Background
Evidence suggests HDL-C is atheroprotective. A proven mechanism for increasing the level of HDL-C is the inhibition of CETP.
Methods
A total of 162 subjects with below-average HDL-C (men <44 mg/dl; women <54 mg/dl) who were not taking lipid-modifying therapy were randomized to double-blind treatment with torcetrapib 10, 30, 60, or 90 mg/day or placebo (not, vert, similar30 subjects per group).
Results
The percent change from baseline to Week 8 with torcetrapib (least-squares mean difference from placebo) was dose-dependent and ranged from 9.0% to 54.5% for HDL-C (p ≤ 0.0001 for 30 mg and higher doses) and from 3.0% to −16.5% for low-density lipoprotein cholesterol (LDL-C) (p < 0.01 for 90-mg dose). Low-density lipoprotein cholesterol lowering was less in subjects with higher (>150 mg/dl) versus lower levels of baseline triglycerides; at 60 mg, the change in LDL-C was 0.1% versus −22.2% (p < 0.0001), respectively. Particle size for both HDL and LDL increased with torcetrapib. There were no dose-related increases in the frequency of adverse events. Significant blood pressure increases were noted in 2 of 140 subjects.
Conclusions
Torcetrapib resulted in substantial dose-dependent elevations in HDL-C, accompanied by moderate decreases in LDL-C at the higher doses. Torcetrapib was generally well tolerated.
Keywords :
nuclear magnetic resonance , NMR , cardiovascular disease , SBP , coronary heart disease , HDL-C , apolipoprotein , cholesteryl ester , DBP , Ce , LDL-C , Adverse event , VLDL-C , systolic blood pressure , CVD , AE , diastolic blood pressure , apo , CHD , CETP , cholesteryl ester transfer protein , high-density lipoprotein cholesterol , low-density lipoprotein cholesterol , very low-density lipoprotein cholesterol
Journal title :
JACC (Journal of the American College of Cardiology)
Journal title :
JACC (Journal of the American College of Cardiology)