ANDROMEDA was a randomized, double-blind, multicenter, parallel-group,
forced-titration trial comparing the efficacy and safety of CRESTOR
(10 mg and 20 mg) and atorvastatin (10 mg and 20 mg) in patients with
type 2 diabetes mellitus. The primary end point was the percentage change
from baseline in LDL-C after 16 weeks. Secondary end points included the
percentage change from baseline in other lipid and lipoprotein variables.
CORALL was an 18-week, randomized, multicenter, open-label, parallel-group,
forced-titration trial comparing the efficacy and safety of CRESTOR
with atorvastatin in 263 patients with type 2 diabetes mellitus and
dyslipidemia. In this trial, patients were randomized to receive
CRESTOR 10 mg or atorvastatin 20 mg for 6 weeks. At week 6, doses
were increased to CRESTOR 20 mg or atorvastatin 40 mg, and at week
12, doses were increased to CRESTOR 40 mg or atorvastatin 80 mg for
a further 6 weeks. Statistical comparisons were not made across the
dose range, only across the same time period (6 weeks vs 6 weeks, 12
weeks vs 12 weeks, 18 weeks vs 18 weeks). The primary end point of CORALL,
the percentage change from baseline in ApoB/ApoA-1 ratio at 6 weeks,
was not significantly different between CRESTOR and atorvastatin.
URANUS was a 16-week, randomized, double-blind, forced-titration trial
comparing CRESTOR and atorvastatin in 465 type 2 diabetics with
dyslipidemia. Patients were randomized to CRESTOR 10 mg or atorvastatin
10 mg for 4 weeks and then titrated up if goal was not met. The primary
end point, percentage change from baseline in LDL-C at 16 weeks, was
significantly better in the rosuvastatin group (10 mg to 40 mg) when
compared with the atorvastatin group (10 mg to 80 mg).