NCEP ATP III Guideline Goal attainment (LDL-C <100 mg/dL) vs atorvastatin in patients with CHD, CHD risk equivalents, or clinical evidence of atherosclerosis
†P<.001 CRESTOR 10 mg vs atorvastatin 10 mg; CRESTOR 20 mg vs atorvastatin 20 mg; CRESTOR 40 mg vs atorvastatin 40 mg; CRESTOR 40 mg vs atorvastatin 80 mg.
Mean baseline LDL-C: 188 mg/dL to 189 mg/dL (all arms of trial).
Week 6:
CRESTOR 10 mg n=498
atorvastatin 10 mg n=510
Week 12:
CRESTOR 20 mg n=492
atorvastatin 20 mg n=494
Week 18:
CRESTOR 40 mg n=480
atorvastatin 40 mg n=483
Week 24:
CRESTOR 40 mg n=464
atorvastatin 80 mg n=476
According to the NCEP ATP III Guidelines, the LDL-C goal for 0 to 1 risk factors is <160 mg/dL, 2+ risk factors (10-year risk <20%) is <130 mg/dL, and CHD or CHD risk equivalents (10-year risk >20%) is <100 mg/dL.
ECLIPSE was a 24-week, open-label, randomized, multicenter,
forced-titration, parallel-group trial comparing the efficacy
and safety of CRESTOR and atorvastatin in patients with
hypercholesterolemia and CHD, CHD risk equivalents (10-year
risk >20%), or clinical evidence of atherosclerosis.
Following a 6-week dietary lead-in period, patients were
randomized to receive CRESTOR 10 mg or atorvastatin 10 mg
for 6 weeks. Doses were force-titrated at 6-week intervals
until maximum doses were achieved. Statistical comparisons
were not made across the dose range, only across the same
time period. The primary end point was percentage of patients
achieving NCEP ATP III LDL-C goal at week 24. Percentage
change from baseline in HDL-C was a secondary end point.