Comparison of Efficacy and Safety of Simvastatin, 10 mg and 20 mg in the Treatment of Hypercholesterolemia Patients Over 60-Year Old

Choi, Hae Jin; Lee, Weon; Han, Kang Won; Kim, Hwa Min; Lee, Jae Goun; Lee, Hyun Hee; Won, Kyung Heon; Kim, Seok Yeon

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 over 60-year-old patients.
METHODS
Seventy-senven patients with hyperlipidemia(triglycerides <400 g/dL and low-density lipoprotein(LDL) cholesterol >130 mg/dL) were randomized to receive either simvastatin 10 mg/day(n=32) or 20 mg/day(n=45). 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 senventy-seven patients randomized to treatment, eighteen patients were men and fiftynine patients were women. sixty-five percent of patients had hypertension, eighteen percent coronary artery disease and fourteen percent type 2 diabetes mellitus. Mean baseline lipid concentrations were 254 (total cholesterol), 291(triglycerides), 50(HDL) and 166 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(32.9 mg/dL vs 24.2 mg/d). There was no significant difference in both doses at improving total cholesterol and HDL cholesterol level and TG cholesterol level. Percentage of patients at goal LDL as recommended by NCEP guideline(ATP III) were 100% and 89% for patients in low risk but 25% and 38.5% 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(6.6%) in the 20 mg group and one patient(3. 1%) 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 over 60 year old 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.