[The efficacy and safety of rosuvastatin on treating patients with hypercholesterolemia in Chinese: a randomized, double-blind, multi-center clinical trial].

OBJECTIVES: This study was designed to evaluate the efficacy and safety of rosuvastatin on treating Chinese patients with hypercholesterolemia. METHODS: This randomized double-blind multi-center study enrolled the patients with LDL-C > or = 160 mg/dL but < 250 mg/dL and TG < 400 mg/dL after six-week dietary run-in. Patients were randomized to receive either rosuvastatin 10 mg/d (R) or atorvastatin (A) 10 mg/d in 2:1 ratio for 12 weeks. Patients with LDL-C levels not reaching goal defined by ATP III guideline in R group were titrated to 20 mg for additional 8 weeks. RESULTS: Altogether, 304 patients were included in the study, 201 patients in R group and 103 in A group. The ITT population is 290 and PP is 263. The LDL-C level decreased after 12 weeks in R group than that in A group, (45.6% vs 39.0%, P < 0.001). The rate reaching the target level defined by ATP III in R group tended to be higher than that in A group (78.0% vs 72.7%), especially in patients with high risk (56.5% vs 35%), however the difference did not reach statistical significance. The magnitudes of TG reduction (-22.8%), HDL-C (+6.6%) and ApoA-1 increase (+12.5%) in R group had no significant difference compared to those in A group (-16.6%, +4.3% and +9.8%, respectively). 29 patients were titrated to receive 20 mg of rosuvastatin. 10 of 22 patients reached the LDL-C target. There were no drug related SAE found during the study. CONCLUSIONS: The efficacy of rosuvastatin in reducing LDL-C is more effective than atorvastatin in the same dose, however, the safety data is similar between them in the period of 3-month follow-up.