TY - JOUR
T1 - Designs of RADIANCE 1 and 2
T2 - Carotid ultrasound studies comparing the effects of torcetrapib/atorvastatin with atorvastatin alone on atherosclerosis
AU - Kastelein, John J.P.
AU - Van Leuven, Sander I.
AU - Evans, Gregory W.
AU - Riley, Ward A.
AU - Revkin, James H.
AU - Shear, Charles L.
AU - Bots, Michiel L.
PY - 2007/4/1
Y1 - 2007/4/1
N2 - 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; 10-80mg 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. Currentstatus: The number of subjects randomized was 904 in RADIANCE 1 and 752 in RADIANCE 2. Results are anticipated in 2007.
AB - 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; 10-80mg 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. Currentstatus: The number of subjects randomized was 904 in RADIANCE 1 and 752 in RADIANCE 2. Results are anticipated in 2007.
KW - Atherosclerosis
KW - Cardiovascular disease (CVD)
KW - Carotid intima-media thickness (CIMT)
KW - Cholesteryl ester transfer protein (CETP)
KW - Clinical trial design
KW - Vascular imaging
UR - http://www.scopus.com/inward/record.url?scp=34247351950&partnerID=8YFLogxK
U2 - 10.1185/030079907X182121
DO - 10.1185/030079907X182121
M3 - Article
C2 - 17407645
AN - SCOPUS:34247351950
SN - 0300-7995
VL - 23
SP - 885
EP - 894
JO - Current Medical Research and Opinion
JF - Current Medical Research and Opinion
IS - 4
ER -