Torcetrapib
RADIANCE 1 and 2 are designed to compare torcetrapib plus atorvastatin against atorvastatin alone in over 1,650 patients using carotid ultrasound (Curr Med Res Opin 2007)
Original title: Designs of RADIANCE 1 and 2: carotid ultrasound studies comparing the effects of torcetrapib/atorvastatin with atorvastatin alone on atherosclerosis
This paper describes the design of the RADIANCE trials, which assessed whether torcetrapib plus atorvastatin slows atherosclerosis progression better than atorvastatin alone, as measured by carotid intima-media thickness, in patients with heterozygous familial hypercholesterolemia (RADIANCE 1) or mixed hyperlipidemia (RADIANCE 2). Both were 2-year, randomized, double-blind, controlled trials in which subjects were titrated to target LDL cholesterol on atorvastatin during a run-in period, then randomized to fixed-dose torcetrapib 60 mg plus atorvastatin or atorvastatin alone, with B-mode ultrasonography performed every 6 months. The primary efficacy measure in both studies was the annualized rate of change in maximum carotid intima-media thickness across 12 predefined segments. A total of 904 subjects were randomized in RADIANCE 1 and 752 in RADIANCE 2, with results anticipated later in 2007.
Original abstract
Objective: The RADIANCE studies were designed to assess the effects of torcetrapib/atorvastatin (T/A) compared with atorvastatin alone on slowing atherosclerotic progression in patients with heterozygous familial hypercholesterolemia (RADIANCE 1) or mixed hyperlipidemia (RADIANCE 2), as measured by change in carotid intima-media thickness (CIMT).
Research Design And Methods: RADIANCE 1 and 2 were randomized, double-blind, controlled trials with a duration of 2 years. In both studies, eligible subjects began treatment with atorvastatin during a run-in period and were titrated to target LDL-C levels defined by NCEP ATP III guidelines. Subjects then proceeded to a double-blind randomized treatment period where they received one of two regimens: (i) fixed combination T/A (torcetrapib dose, 60 mg), or (ii) atorvastatin alone. In both regimens, the dose of atorvastatin was established during the run-in period (20-80 mg, RADIANCE 1; 10-80 mg RADIANCE 2). B-mode ultrasonography was performed in duplicate at baseline and at end of study, and every 6 months in between.
Main Outcome Measures: The primary efficacy measure in both studies was the annualized rate of change in maximum CIMT of 12 pre-defined carotid segments. Further outcome measures included lipid and safety assessments.
Current Status: The number of subjects randomized was 904 in RADIANCE 1 and 752 in RADIANCE 2. Results are anticipated in 2007.
Summary written by cetpinhibition.org from the published abstract; figures as published. Page updated 18 August 2026. Methods.