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- Zhao Shuiping,
- A group of study on effic and
- Zhao Shuiping
This study aims to evaluate the effect of low and moderate doses of rosuvastatin on lowering LDL-C level and the goal achievement rate of LDL-C in Chinese patients with hypercholesterolemia as compared to the efficacy of atorvastatin 10 mg/d.
The study population included male and female subjecte, aged ≥18 years, LDL-C ≥ 3.4mmol/L(130 mg/dL) and <6.5mmol/L(250 mg/dL) for statin-na?ve patients. A total 436 patients with hypercholesterolemia were enrolled from 13 medical centers. Subjects were randomized to rosuvastatin 5 mg/d, rosuvastatin 10 mg/d, or atorvastatin 10 mg/d in a double-blind, parallel group trial. The concentrations of lipid profiles were measured in the baseline and after 6 weeks of treatment. The subjects without the LDL-C goal achievement after 6 weeks of treatment entered an open-label and were forced in rosuvastatin 20 mg/d treatment period for another 6 weeks.
A total of 414 subjects were finally included into intention-to-treat data analysis.The reduction percentages of LDL-C level from baseline after 6-week treatment were 41.70±2.62%, 46.28±2.62%, and 38.67±2.64% in rosuvastatin 5 mg, rosuvastatin 10 mg, and atorvastatin 10 mg group, respectively. According to ATP III guideline, the achievement rates of LDL-C were 61.0%, 79.1%, and 58.3% in rosuvastatin 5 mg, rosuvastatin 10 mg, and atorvastatin 10 mg group, respectively. Among patients without goal achievement in the double blind phase, there were 41.2% (14 of 34 patients) achieved LDL-C goal after dose titration from rosuvastatin 5 mg to 10 mg and 47.6% (10 of 21 patients) achieved LDL-C goal after dose titration from rosuvastatin 10 mg to 20 mg. The tolerability of rosuvastatin 5 mg and 10 mg was comparable to atorvastatin 10 mg during the randomized treatment period with low incidence of discontinuation of investigational drug .
Rosuvastatin presents an efficient dose-related activity on lowering LDL-C plasma level and is well tolerated in Chinese hypercholesterolemia patients.