A Randomized Controlled Study to Compare the Effects of Rosuvastatin 5 mg and Atorvastatin 10 mg on the Plasma Lipid Profile in Japanese Patients with Hypercholesterolemia (ASTRO-2).

OBJECTIVE For new evidence of aggressive lipid lowering treatment with statins in Japanese hypercholesterolemic patients, we performed an open-label, randomized, parallel-group comparative study to assess the effect of rosuvastatin 5 mg and atorvastatin 10 mg on plasma lipids. METHODS A total of 900 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 5 mg / day (n = 450) or atorvastatin 10 mg / day (n = 450) for 8 weeks. The primary endpoint was the percent change of LDL-C at week 8. RESULTS LDL-C was lowered by -44.5% (from 170.2 to 93.3 mg / dL) in the rosuvastatin group and -41.6% (from 169.5 to 97.9 mg / dL) in the atorvastatin group, at week 8 (P = 0.002 vs. atorvastatin). LDL-C / HDL-C ratio was lowered by -47.6% (from 3.01 to 1.56) and -43.5 % (from 2.96 to 1.66), respectively, at week 8 (P < 0.001 vs. atorvastatin). The changes in HDL-C, ApoB, ApoA-1, and ApoB / ApoA-1 ratio showed significant improvement in the rosuvastatin group than in the atorvastatin group. Adverse events were observed comparably between the rosuvastatin group (121 events) and the atorvastatin group (104 events). None of these events had adverse clinical consequence. Both drugs were well tolerated. CONCLUSION Rosuvastatin 5 mg produced significantly greater reduction in LDL-C and beneficial effect on other lipid parameters than atorvastatin 10 mg, and was also well tolerated.