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Efficacy and Safety of Torcetrapib, a Novel Cholesteryl Ester Transfer Protein Inhibitor, in Individuals With Below-Average High-Density Lipoprotein Cholesterol Levels

Michael H. Davidson, MD, FACC^_*,_*, James M. McKenney, PharmD, Charles L. Shear, DrPH and James H. Revkin, MD, FACC

^_* Rush-Presbyterian-St. Luke’s Medical Center, Chicago, Illinois
Virginia Commonwealth University, Richmond, Virginia
Pfizer Global Research and Development, New London, Connecticut

View larger version (20K): [in this window] [in a new window] [Download PPT slide]   Figure 1 Schematic representation of study design and numbers of subjects. Sample size was calculated based on earlier torcetrapib studies, with 25 subjects per group yielding 80% power to detect a 25% treatment difference in high-density lipoprotein cholesterol (HDL-C), assuming a common standard deviation of 30.5% and 2-sided t test with 5% type I error. LOCF = last observation carried forward (i.e., subjects with baseline and at least one post-baseline HDL-C measurement); R = randomization.

View larger version (22K): [in this window] [in a new window] [Download PPT slide]   Figure 2 Mean change in high-density lipoprotein cholesterol (HDL-C) over the course of the study—all subjects.

View larger version (23K): [in this window] [in a new window] [Download PPT slide]   Figure 3 Mean change in low-density lipoprotein cholesterol (LDL-C) over the course of the study—all subjects.

View larger version (22K): [in this window] [in a new window] [Download PPT slide]   Figure 4 Change in low-density/high-density lipoprotein cholesterol (LDL-C/HDL-C) ratio over the course of the study—all subjects.

View larger version (34K): [in this window] [in a new window] [Download PPT slide]   Figure 5 Least-squares mean change in systolic (A) and diastolic (B) blood pressure over the course of the study.