Abstract: Aim The efficacy and safety of the domestic simvastatin in the treatment of primary hypercho lesterolemia were compared with those of the imported simvastatin.Methods A controlled,multicenter,open-abel and randomized clinicaltrial was performed in 156 patients,of whom 56 received domestic simvastatin,56 took imported simvastatin and 44 in the open group,also took domestic simvastat in in a do se of 10mg·d^-1at night for 8weeks.Results In the domestic simvastatin group and the imported simvastatin group the serum total cholesterol(TC)was reduced by 26.73% and 25.62% respectively,and the low density lipoprotein cholesterol (LDL-C)by 40.47% and 36.41% respectively.The total efficacy of the two groups was 94.62% and 91.07% respectively.The side effects w ere mild in the discomfort of gast rointestine and the increase of CPK.The re was no significant difference between two groups about the efficacy and the safety.In the open group TC and LDL-C were reduced by 25.50% and 40.57% respectively,the overall efficacy was86.36%.Conclusion Domest icsimvastatin is one of the safe and effective drug s to treat the hypercho lesterolemia.

Key words: simvastatin, hypercholesterolemia, efficacy, safety