Efficacy of Fluvastatin in Patients with Hypercholesterolemia

Moon-Ho KANG; Sung-Gwang LEE; Jung-Ho YOUN; Tae-Suk KIM; Seung-Woon AHN

Background:

Fluvastatin is the first entirely synthetic 3-hydroxy-3-methylglutaryl-coenzyme A(HMG-CoA) reductase inhibitor. Clinical data indicate that this agent exhibits the proven efficacy of its class and also has some theoretical advantages in safety for long-term use because of its unique pharmacololgic property consistent with hepatoselectivity(i.e., low systemic exposure). This study is to evaluate efficacy and safety of fluvastatin in hypercholesterolemic patients in Korea.

Methods:

An open clinical trial with fluvastatin was conducted in 31 subjects who continued to have high blood cholesterol levels of 6.21 mmol/L(240 mg/dl) or greater after 1 month of lipid-lowering diet plus single blind placebo period. Fluvastatin was administered for 8 weeks with the initial dose of 20 mg per day and if serum cholesterol levels did not fall below 5.20 mmol/L(200 mg/dl) after 4 weeks the dose was increased to 40 mg per day for the second 4 weeks. On each visit every 4 weeks they underwent interview and laboratory tests about side effects and tolerability.

Results:

The mean % changes in plasma total cholesterol and LDL-cholesterol from baseline were

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