J Korean Soc Endocrinol.  1999 Dec;14(4):729-738.

Cholesterol Lowering Effect of Cerivastatin in Korean Patients with Primary Hypercholesterolemia

• Kim SH
• Kim DJ
• Hahm JR
• Kim BJ
• Chung JH
• Min YK
• Lee MS
• Lee MK
• Kim KW

Abstract

BACKGROUND
Cerivastatin is a kind of statin, a synthetic HMG-CoA reductase inhibitor with high liver selectivity which lowers plasma cholesterol level by inhibiting endogenous cholesterol synthesis. This study evaluates the efficacy, safety, and tolerability of cerivastatin 0.1 mg and 0.3 mg in Korean patients with primary hypercholesterolemia.
METHODS
A parallel group, randomized, placebo-controlled, double-blind study was conducted at Samsung Medical Center. The patients with primary hypercholesterolemia were placed on an American Heart Association Step 1 diet for whole study period. Single-blind placebo was administered for the final 4 weeks of period A, before randomization. Thirty two patients with low-density lipoprotein cholesterol (LDL-C) >160 mg/dL (if patients with a definite personal history of coronary heart disease (CHD) or with two or more cardiovascular risk factors, LDL-C >130 mg/dL) were randomized to 6 weeks treatment with one of the following regimens: cerivastatin 0.1 mg (n=11) or cerivastatin 0.3 mg (n=10) or placebo once daily at bedtime (n=11).
RESULTS
Cerivastatin 0.1 mg and 0.3 mg treatment groups produced statistically significant (p<.05) changes at 6 weeks after treatment, compared to baseline and placebo in LDL-C (cerivastatin 0.1 mg 16.3%; cerivastatin 0.3 mg 35.2%; placebo 1.5%) and total cholesterol (cerivastatin 0.1 mg 10.3%; cerivastatin 0.3 mg 26.2%; placebo 1.3%). Cerivastatin 0.1 mg and 0.3 mg treatments were well tolerated and resulted in no significant increase in biochemical or clinical side effects compared to placebo.
CONCLUSION
Cerivastatin at doses of 0.1 mg and 0.3 mg/day is a safe, well-tolerated, and highly effective HMG-CoA reductase inhibitor for the treatment of primary hypercholesterolemia.

MeSH Terms

American Heart Association
Cholesterol*
Coronary Disease
Diet
Double-Blind Method
Humans
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypercholesterolemia*
Lipoproteins
Liver
Oxidoreductases
Plasma
Random Allocation
Risk Factors
Cholesterol
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Lipoproteins
Oxidoreductases