Multicenter Clinical Trial of Atorvastatin in Patients with Hypercholesterolemia

ABSTRACT

BACKGROUND & OBJECTIVES: The aim of this study was to investigate the efficacy & safety of a new HMG-CoA reductase inhibitor, atorvastatin, to improve serum lipid profiles in patients with primary hypercholesterolemia. MATERIALS AND METHODS: Three hundred and six patients from 21 hospitals, all with total cholesterol level over 240 mg/dl and triglyceride level below 400 mg/dl were enrolled in the study. Following diet therapy for 2 weeks, atorvastatin 10 mg was taken for 6 weeks if the total cholesterol level remained higher than 240 mg/dl. The percent change of total cholesterol, triglyceride, LDL-cholesterol and HDL-cholesterol from baseline to 6 weeks of treatment were evaluated. Patients were monitored for safety through careful history talking, physical examination, serum sampling for liver and muscle enzyme. RESULTS: 1) The study was completed in a total of 166 patients. The mean age of patients the was 58 1/2 years and the percent of male and female patients was 37%, 37% and 63%, respectively. 2) The baseline mean values of total cholesterol, triglyceride, LDL-cholesterol, HDL-cholesterol following diet therapy for 2 weeks were 280+/-34 mg/dl, 172+/-77 mg/dl, 190+/-35 mg/dl, 56+/-13 mg/dl, respectively. 3) After 6 weeks treatment, the level of total cholesterol, triglyceride, LDL-cholesterol, HDL-cholesterol were 195+/-34 mg/d, 150+/-67 mg/dl, 110+/-33 mg/dl, 55+/-12 mg/dl, respectively, and the rates of change were -30%, -7%, -42%, -0.2%, respectively. 4) The level of LDL-cholesterol at the end of treatment was below 100 mg/dl in 44%, 100-130 mg/dl in 33%, 130-160 mg/dl in 14%, over 160 mg/dl in 9% of patients. 5) 77% of total patients achieved the target goal of LDL cholesterol (below 130 mg/dl) according to the NCEP guideline. 6) The reduction rate of LDL-cholesterol was different among the patients. At the end of treatment, the patients with initial LDL-cholesterol below 100 mg/dl achieved a higher reduction rate (52%) as compared with those patient's inithal LDL-cholesterol level were higher. 7) There are was only 1 patient (0.6%) who showed 3 times a three-fold increase of liver enzyme and no patient showed an increase of creatine kinase. CONCLUSION: Atorvastatin is effective and safe in improving the lipid profiles in of patients with hypercholesterolemia without serious side effects. (Korean Circulation J 2001;31 (4)434-441)