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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 on a Background of Atorvastatin

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

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

View larger version (23K): [in this window] [in a new window] [Download PPT slide]   Figure 1 Schematic representation of study design and numbers of patients. At screening, patients were required to: 1) have a high-density lipoprotein cholesterol (HDL-C) level <44 mg/dl for men and <54 mg/dl for women, and 2) be on statin therapy or have a low-density lipoprotein cholesterol (LDL-C) level >130 mg/dl. A total of 69 patients were already receiving statin therapy at screening. Sample size was calculated based on earlier torcetrapib studies, with 25 patients per group yielding 80% power to detect a 25% treatment difference in 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., patients with baseline plus 1 post-baseline HDL-C measurement); R = randomization.

View larger version (29K): [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 patients.

View larger version (29K): [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 patients.

View larger version (28K): [in this window] [in a new window] [Download PPT slide]   Figure 4 Change in LDL-C/HDL-C ratio over the course of the study—all patients. HDL-C = high-density lipoprotein cholesterol; LDL-C = low-density lipoprotein cholesterol.

View larger version (31K): [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.