Designs of RADIANCE 1 and 2: carotid ultrasound studies comparing the effects of torcetrapib/atorvastatin with atorvastatin alone on atherosclerosis.
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).


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.


METHODS
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.


RESULTS
The number of subjects randomized was 904 in RADIANCE 1 and 752 in RADIANCE 2. Results are anticipated in 2007.
Kastelein
John J P
JJ
Department of Vascular Medicine, Academic Medical Center, University of Amsterdam, The Netherlands.
van Leuven
Sander I
SI
Evans
Gregory W
GW
Riley
Ward A
WA
Revkin
James H
JH
Shear
Charles L
CL
Bots
Michiel L
ML
D000293:Adolescent; D000328:Adult; D000368:Aged; D000465:Algorithms; D000924:Anticholesteremic Agents / Q000008:administration & dosage; D050197:Atherosclerosis / Q000000981:diagnostic imaging* / Q000209:etiology / Q000517:prevention & control*; D000069059:Atorvastatin; D002339:Carotid Arteries / Q000033:anatomy & histology / Q000000981:diagnostic imaging / Q000187:drug effects*; D002986:Clinical Trials as Topic; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006538:Heptanoic Acids / Q000008:administration & dosage*; D006801:Humans; D006950:Hyperlipidemia, Familial Combined / Q000150:complications / Q000188:drug therapy; D006938:Hyperlipoproteinemia Type II / Q000150:complications / Q000188:drug therapy; D008297:Male; D008875:Middle Aged; D008954:Models, Biological; D011758:Pyrroles / Q000008:administration & dosage*; D011804:Quinolines / Q000008:administration & dosage*; D012107:Research Design; D017539:Tunica Intima / Q000033:anatomy & histology / Q000000981:diagnostic imaging / Q000187:drug effects; D014463:Ultrasonography
D000924:Anticholesteremic Agents; D006538:Heptanoic Acids; D011758:Pyrroles; D011804:Quinolines; C483909:torcetrapib; D000069059:Atorvastatin