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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

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.

Trial
Journal Ref. Davidson M, et al. Am J Cardiol 2002, 89:268-275.
Intervention Drug - 12 week treatment with Rosuvastatin 10mg
Number of sites 52
Countries involved 1
Sample size 519
Type of statistical analyses ITT
Risk of bias Overall: Unclear details
Participant characteristics Age: 56.4-57.9 ± 12.7
Condition: Type 11a or 11b Hypercholesterolemia
Baseline severity: Fasting low density lipoprotein (LDL) cholesterol ≥ 4.14 mmol/L (160 mg/dl) and <6.67 mmol/L (250mg/dl) and triglycerides ≥4.52 mmol/L (400 mg/dl)
Duration of trial Unclear
Primary outcome Percent change in LDL cholesterol from baseline to week 12
Effect Measures
Events Intervention Total Events Control Total Risk Diff.
108 128 93 127 11.15 %
p < 0.001. The effect size is for secondary outcome: percentage of patients achieving EU LDL cholesterol goals at 12 weeks: Other comparators placebo 13% at goal, Rosuvastatn 5mg 84% at goal - European Atherosclerosis Society LDL Cholesterol Goals at 12 weeks.
Show Score Ranges

Scores:

(shows median if more than one score was entered)

Elig. Recr. Setting Org. Int. Flex. Del. Flex. Adherence Follow-Up Prim. Out. Prim. An.
1 3 4 4 3 1 1 1 2