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

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Abstract

This randomized, double-blind, placebo-controlled trial was conducted in 52 centers in North America to compare the effects of the new, highly effective statin, rosuvastatin, with atorvastatin and placebo in hypercholesterolemic patients. After a 6-week dietary run-in, 516 patients with low-density lipoprotein (LDL) cholesterol ≥4.14 mmol/L (160 mg/dl) and <6.47 mmol/L (250 mg/dl) and triglycerides ≤4.52 mmol/L (400 mg/dl) were randomized to 12 weeks of once-daily placebo (n = 132), rosuvastatin 5 mg (n = 128), rosuvastatin 10 mg (n = 129), or atorvastatin 10 mg (n = 127). The primary efficacy end point was percent change in LDL cholesterol. Secondary efficacy variables were achievement of National Cholesterol Education Program (NCEP) Adult Treatment Panel II (ATP II), ATP III, and European Atherosclerosis Society LDL cholesterol goals and percent change from baseline in high-density lipoprotein (HDL) cholesterol, total cholesterol, triglycerides, non-HDL cholesterol, apolipoprotein B, and apolipoprotein A-I. Rosuvastatin 5 and 10 mg compared with atorvastatin 10 mg were associated with greater LDL cholesterol reductions (−40% and −43% vs 35%; p <0.01 and p <0.001, respectively) and HDL cholesterol increases (13% and 12% vs 8%, p <0.01 and p <0.05, respectively). Total cholesterol and apolipoprotein B reductions and apolipoprotein A-I increases were also greater with rosuvastatin; triglyceride reductions were similar. Rosuvastatin 5 and 10 mg were associated with improved achievement in ATP II (84% in both rosuvastatin groups vs 73%) and ATP III (84% and 82% vs 72%) LDL cholesterol goals, and rosuvastatin 10 mg was more effective than atorvastatin in achieving European Atherosclerosis Society LDL cholesterol goals. Both treatments were well tolerated.

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.

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