Comparison of effects on low-density lipoprotein cholesterol and high-density lipoprotein cholesterol with rosuvastatin versus atorvastatin in patients with type IIa or IIb hypercholesterolemia☆
Section snippets
Methods
Men and women aged ≥18 years with hypercholesterolemia were enrolled in a 6-week dietary lead-in period at 52 centers. During this time all cholesterol-lowering treatments were discontinued; NCEP step I dietary instructions were given and compliance was monitored using the Eating Pattern Assessment Tool. Eligibility criteria for the randomized treatment period included a fasting LDL cholesterol level ≥4.14 mmol/L (160 mg/dl) and <6.47 mmol/L (250 mg/dl) and a fasting triglycerides level ≤4.52
Patients:
Of a total of 1,888 patients entering the screening phase (Figure 1), 519 subsequently met the clinical, dietary, biochemical, and lipid entry criteria and were randomized to placebo (n = 132), rosuvastatin 5 mg (n = 129), rosuvastatin 10 mg (n = 130), or atorvastatin 10 mg (n = 128). Three patients (1 in each of the active treatment groups) were excluded from the intention-to-treat analysis because they did not take the study medication. The groups were well matched with respect to race (>80%
Discussion
In this study, rosuvastatin at both 5 and 10 mg produced significantly greater reductions in LDL cholesterol, total cholesterol, and apolipoprotein B and significantly greater increases in HDL cholesterol and apolipoprotein A-I than did the 10-mg dose of atorvastatin after a 12-week treatment period. The LDL cholesterol reductions observed with rosuvastatin resulted in a large percentage of patients (82% to 84%) with baseline LDL cholesterol levels between 160 and 250 mg/dl achieving NCEP ATP
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This study was supported by a grant from AstraZeneca, Alderley Park, Cheshire, United Kingdom.