Efficacy and safety of rosuvastatin in Taiwanese patients.

BACKGROUND

Statins are effective in decreasing low-density lipoprotein cholesterol (LDL-C). The efficacy and safety of rosuvastatin, a newly launched statin, have not been determined in Taiwanese patients.

METHODS

Patients with hypercholesterolemia receiving rosuvastatin 10 mg/d in this hospital were prospectively followed and retrospectively analyzed. Men and women with primary hypercholesterolemia were eligible for inclusion in the study if they were either lipid-lowering therapy (LTT)-naive or had been receiving starting doses of other LLT that had proved ineffective in reaching goals. The primary measurement was the percentage of change in LDL-C from baseline at 12 weeks. Other measurements included: percentages of change from baseline in total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), triglyceride (TG), TC/HDL ratio, percentage of patients reaching therapeutic goals, and any adverse effects at 12 weeks. Both intention-to-treat analysis and on-treatment analysis were used.

RESULTS

A total of 447 patients, including 375 LTT-naive and 72 switched patients were enrolled. In LLT-naive patients, rosuvastatin 10 mg/d reduced LDL-C by a mean of 48.9% from baseline (p < 0.0001) by the on-treatment analysis and by a mean of 44.2% from baseline (p < 0.0001) by the intention-to-treat analysis. In switched patients, LDL-C was reduced by a mean of 26.2% from baseline (p < 0.0001) by both analyses. TC, TG, and TC/HDL ratio, but not HDL-C, were also significantly reduced. Overall, more than 75% patients reached their therapeutic goals. The safety profiles were excellent. Only 2.2% of patients complained of myalgia, 0.2% had elevation of creatine kinase > 3 x upper limit of normal (ULN), and 0.6% had an elevation of ALT > 3 x ULN. All the abnormal laboratory tests returned to pretreatment values after drug discontinuation. Only 2.7% of patients discontinued medication due to adverse effects.

CONCLUSION

Rosuvastatin 10 mg/d is safe and effective in Taiwanese patients.