Cholesterol Lowering Effect of Cerivastatin in Korean Patients with Primary Hypercholesterolemia / 대한내분비학회지

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.