Korean multicenter clinical trial of simvastatin ( KS-1 study ) / 대한내과학회지

ABSTRACT

The aim of this study was to investigate the efficacy of simvastatin to improved lipid profiles in hypercholesterolemic Korean patients. METHODS: From 25 hospitals in Korea, 478 hypercholesterolemic patients were enrolled from November 1996 to April 1998. The inclusion criteria was hypercholesterolemia over 240 mg/dl after diet therapy for 1 month or hypercholesterolemia over 220 mg/dl in patients with definite evidence of ischemic heart disease. Simvastatin 10mg was started and doubled up to 40mg if total cholesterol level remained higher than 200 mg/dl at monthly check. Of 478 subjects, 344 patients in whom study protocol was not violated were analyzed. RESULTS: Male to female ratio was 2773 and 47% of the subjects were in 6th decade. Hypertension, coronary artery disease, and diabetes mellitus were present in 30, 10, and 4% of the subjects. Baseline lipid profile (mean of total cholesterol-LDL-HDL-triglyceride mg/dl) was 274-185-52-188. The dose of simvastatin for 3 months was 10/10/10mg in 61% of subjects, 10/20/20mg in 21%, 10/10/20mg in 7%, and 10/20/40mg in 12%. The change of total cholesterol level(before-4wk-8wk-12wk-withdrawal 4wk) was 274-209- 205-198-250, and the maximal reduction rate was 27%. The change of LDL-cholesterol was 185-123-116-110-159, with maximal reduction rate 39%. The change of HDL-cholesterol was 52-54-56-55-54, with maximal increase rate 9%. The change of tryglyceride was 188-161- 164-162-189, with maximal reduction rate 15%. The value before/after treatment of ApoA1, ApoB, and Lp(a) was 129/129, 138/83, and 9.3/10.7, respectively. The level of LDL-cholesterol at the end of treatment was below 100mg/dl in 36% of subjects, 100-130 in 45%, 130-160 in 16%, and over 160mg/dl in 4%. The reduction rate of LDL-cholesterol was different between subjects whose LDL decreased below 100 and those whose LDL did not decrease below 130mg/dl, which suggests the existence of the individual difference of responsiveness to simvastatin. There were only 3 subjects (0.9%) who showed increase of liver enzyme over 3 times as the upper normal limit. Conclusion: Simvastatin is effective in improving lipid profiles in hypercholesterolemic Korean patients without serious side effects.