Patients with elevated
low-density lipoprotein (
LDL) cholesteral levels are at high risk of cardiovascular events but are often undertreated and fail to achieve
lipid goals. This open-label, noncomparative, multicenter study assessed efficacy and safety of
rosuvastatin 40 mg for < or =96 weeks in 1,380 patients with severe
hypercholesterolemia, including heterozygous
familial hypercholesterolemia. Patients > or =18 years old with fasting
LDL cholesterol > or =190 and < or =260 mg/dl and
triglycerides <400 mg/dl entered a 6-week dietary lead-in, before receiving
rosuvastatin 40 mg for 48 weeks. An optional additional 48-week treatment period followed. The initial period had 2 primary end points: percentage of patients achieving National
Cholesterol Education Program (NCEP) Adult Treatment Panel (
ATP) III
LDL cholesterol goals at 12 weeks, and long-term safety, assessed during 48 weeks by incidence and severity of adverse events (AEs) and abnormal laboratory values. Safety was the primary end point in the extension period. At 12 weeks, 83% of patients achieved NCEP
ATP III
LDL cholesterol goals, which were maintained during 48 and 96 weeks (81% and 84%, respectively). At 48 weeks,
rosuvastatin 40 mg reduced
LDL cholesterol from baseline by 52% and increased
high-density lipoprotein (
HDL) cholesterol by 11% (both p <0.0001). At 96 weeks,
LDL cholesterol was reduced by 54% and
HDL cholesterol increased by 13%.
Rosuvastatin 40 mg was well tolerated during 96 weeks. The overall pattern and incidence of AEs and abnormal laboratory values were consistent with the published safety profile of
rosuvastatin and higher doses of other
statins. In conclusion, long-term treatment with
rosuvastatin 40 mg is safe and effective in patients with severe
hypercholesterolemia.