Efficacy and safety of 12-week treatment with fenofibrate 300 mg in Thai dyslipidemic patients.

BACKGROUND: High levels of low density lipoprotein (LDL) cholesterol is a known major factor in atherosclerosis. In addition to LDL-cholesterol, an increase in the triglycerides-rich lipoprotein and a decrease in HDL-cholesterol increase the risk of coronary artery disease. Fenofibrate, a fibric acid derivative, is highly effective in reducing serum triglycerides and LDL-cholesterol and produces a modest increase in HDL-cholesterol. The present study was done to evaluate the efficacy of fenofibrate at 300 mg daily on serum lipid profiles and to study the drug safety and tolerability of fenofibrate in Thai patients. MATERIAL AND METHOD: Forty patients with elevated serum total cholesterol, LDL cholesterol were recruited for 12 weeks of 300 mg per day of fenofibrate therapy. Blood analysis for lipid profiles, liver function test, creatinine and muscle enzyme were done at the begining and end of the study. RESULTS: The mean baseline total cholesterol, LDL-cholesterol, triglycerides and HDL-cholesterol were 249 mg/dl, 160 mg/dl, 325 mg/dl and 43 mg/dl respectively. Significant changes of all lipid parameters from baseline were observed after 12 weeks of treatment. Reduction of serum total cholesterol, LDL-cholesterol and triglycerides were 16, 23, and 41 percent respectively. Increased serum HDL-cholesterol of 14 percent was also observed. One patient withdrew from the trial due to chest pain. Two asymptomatic elevated transaminase were detected during the study. CONCLUSION: Fenofibrate at 300 mg per day is effective and safe in treating Thai patients with dyslipidemia.