고콜레스테롤혈증 환자에서 Fluvastatin의 임상 효능 = Efficacy of Fluvastatin in Patients with Hypercholesterolemia

다국어 초록 (Multilingual Abstract)

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 -14.6% and -20.2% at 4 week, and -19.5% and -24.7% at 8 week respectively(p$lt;0.001). No significant change in plasma triglyceride was found in the overall group, but when analysis is confined to those with hypertriglycedemia combined(TG$gt;- 2.26 mmol/L or 200 mg/dl), plasma triglyceride levels were significantly reduced by 23.3% at 8 week(p$lt;0.05). There was no significant change in HDL-cholesterol during fluvastatin treatment. Three patients had mild gastrointestinal symptoms and one patient developed drowsiness, no symptoms were severe enough to discontinue the medication. Notable laboratory abnormalities including serum transaminase and creatine kinase elevations were not observed.
Conclusion: This study suggests that fluvastatin is an effective, safe, and well-tolerated lipid lowering agent in the treatment of hypercholesterolemia. Controlled clinical studies on large scale and long-term basis should be followed(J Kor Soc Endocrinol 11:75-84, 1996).