Multicenter Clinical Trial of Atorvastatin in Patients with Hypercholesterolemia

Bae, Jong Hwa

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)