A Randomized Controlled Study to Compare the Effects of Rosuvastatin 2.5 mg and Pravastatin 10 mg on the Plasma Lipid Profile in Japanese Patients with Hypercholesterolemia (ASTRO-1).

OBJECTIVE For new evidence of treatment with statins in Japanese hypercholesterolemic patients, we performed an open-label, randomized, parallel-group comparative study to assess the effect of rosuvastatin 2.5 mg and pravastatin 10 mg on plasma lipids. METHODS A total of 100 patients in whom the target control levels of LDL-cholesterol (LDL-C) set by the Japan Atherosclerosis Society Guidelines (JASGL2007) had not been achieved were randomly assigned to receive rosuvastatin 2.5 mg / day or pravastatin 10 mg / day for 8 weeks. The primary endpoint was the percent change of LDL-C at week 8. RESULTS LDL-C was lowered by -40.3% (from 160.3 to 95.1 mg / dL) in the rosuvastatin group and -22.9% (from 162.9 to 126.0 mg / dL) in the pravastatin group, at week 8 (P < 0.001 vs. pravastatin). LDL-C / HDL-C ratio was lowered by -41.3% (from 2.85 to 1.69) and -20.6% (from 2.81 to 2.24), respectively (P < 0.001 vs. pravastatin). The rate of achievement of the target LDL-C control level at week 8 was significantly higher in the rosuvastatin group (98.0%) than in the pravastain group (78.7%) (P = 0.003). Both drugs were well tolerated. CONCLUSION Rosuvastatin 2.5 mg produced significantly greater reduction in LDL-C and beneficial effect on other lipid parameters than pravastatin 10 mg, and its safety profile is similar to pravastatin 10 mg.