Comparison of efficacy and safety of simvastatin, 10 mg and 20 mg in the treatment of hypercholesterolemia / 대한내과학회지

ABSTRACT

BACKGROUND: Elevated serum cholesterol level is a major risk factor for cardiovascular morbidity and mortality. Simvastatin is effective for treating hypercholesterolemia. The aim of the study was to evaluate efficacy and safety of 6-month therapy with simvastatin with relatively low dose, 10 mg and 20 mg/day. METHODS: One hundred six patients with hyperlipidemia (triglycerides130 mg/dL) were randomized to receive either simvastatin 10 mg/day (n=43) or 20 mg/day (n=63). Efficacy was determined by measuring changes from baseline in lipid parameters including LDL cholesterol, total cholesterol, triglycerides and high-density lipoprotein (HDL) cholesterol. RESULTS: Of the one hundred six patients randomized to treatment, forty patients were men and sixty-six patients were women. Fifty-five percent of patients had hypertension, nine percent coronary artery disease and thirteen percent type 2 diabetes mellitus. Mean baseline lipid concentrations were 258 (total cholesterol), 201 (triglycerides), 50 (HDL) and 167 mg/dL (LDL). Both 10 mg and 20 mg of simvastatin produced statistically significant improvements in all measured serum lipid parameters (p< 0.001). Compared with 10 mg of simvastatin, 20 mg of simvastatin produced significantly greater (p< 0.001) reductions from baseline LDL cholesterol (34.9 mg/dL vs 20.8 mg/dL). But 10 mg of simvastatin was more effective than 20 mg of simvastatin at reducing triglycerides level (42.7 mg/dL vs 22.3 mg/dL). There was no significant difference in both doses at improving total cholesterol and HDL cholesterol level. Percentage of patients at goal LDL as recommended by NCEP guideline (ATP III) were 81% and 80% for patients in low risk but 35% and 50% for patients in coronary heart disease and its risk equivalents, taking 10 mg and 20 mg/day respectively. Both doses were well tolerated. Only 3 patients (4.8%) in the 20 mg group and one patient (2.3%) in the 10 mg group experienced mild adverse events. Most patients contacted by telephone wanted to take 10 mg of simvastatin. CONCLUSION: In patients with hypercholesterolemia in Korea, both doses (10 mg, 20 mg) of simvastatin were effective in improving serum lipid parameters and well-tolerated. We recommend, considering patients' preference, that 10 mg of simvastatin be intial dosage and in patients with coronary heart disease, higher doses than 20 mg should be prescribed to allow most patients to reach their NCEP target levels.