The safety and efficacy of ezetimibe and simvastatin combination therapy in Korean patients with primary hypercholesterolemia / 대한내과학회지

ABSTRACT

BACKGROUND: The prevalence of hypercholesterolemia in Korea is growing. In spite of the wide use of HMG-CoA reductase inhibitors (statins), some patients don't reach optimal cholesterol reduction and suffer hepatotoxicity or myopathy. Combination therapy of lipid lowering agents, which inhibits hepatic synthesis of cholesterol (i.e. simvastatin) and intestinal cholesterol absorption (i.e. ezetimibe), may achieve further reduction of serum cholesterol levels and less drug side effects. This study assessed the safety and efficacy of the combination therapy with ezetimibe and simvastatin in Korean patients with primary hypercholesterolemia. METHODS: This study was a randomized, double-blind, simvastatin controlled, multi-center trial. After 4 weeks of life style modification for cholesterol reduction, patients with a baseline low-density lipoprotein cholesterol (LDL-C) 145~250 mg/dL and triglyceride (TG) simvastatin 10 mg plus placebo or simvastatin 10 mg plus ezetimibe 10 mg daily for 12 weeks. The primary efficacy variable was mean percent change of LDL-C reduction from the baseline level at 8 and 12 weeks after the study drug administration.

RESULTS:

Ezetimibe plus simvastatin combination therapy significantly reduced LDL-C compared with simvastatin monotherapy (173.7 to 84.0 mg/dL, -50.9% vs. 172.6 to 109.9 mg/dL, -36.3%, p<0.001). Combination therapy reduced significantly total cholesterol (TC) and apolipoprotein B (ApoB) level, but changes of high-density lipoprotein cholesterol (HDL-C), apolipoprotein A1 (ApoA1) and lipoprotein (a) didn't show statistically significant difference between two groups. Combination therapy was well tolerated. Safety profiles in both groups were similar.

CONCLUSION:

Ezetimibe plus simvastatin combination therapy reduced LDL-cholesterol level more than simvastatin monotherapy did in efficacy, and was well tolerated and comparable to simvastatin monotherapy in safety.