Safety, Tolerability, and Efficacy of Simvastatin and Fenofibrate - A Multicenter Study

Five centers participated in a double-blind, randomized, active-drug controlled study. The selected patients had a diagnosis of primary hypercholesterolemia (phenotype Ha or lib, total cholesterol [TC] > 300 mg/dl, low-density lipoprotein [LDL] cholesterol > 195 mg/dl, triglycerides [TG] < 350 mg/dl). Throughout the study the patients observed a lipid-lowering diet (American Heart Association). After a baseline placebo period (4 weeks) the patients were randomly assigned to simvastatin 20 mg q. p. m. or fenofibrate 200 mg b. i. d. If after 6 weeks of treatment the LDL cholesterol level remained over 140 mg/dl the dose of simvastatin was doubled. The total duration of treatment was 10 weeks. One hundred eighty-four patients completed the study; age ranged from 17 to 72 years (mean 46; 129 men, 55 women). Seventy-nine patients had ischemic heart diseases.Simvastatin significantly reduces TC, LDL, and apolipoprotein (apo) B (30% 35% and 27% respectively). These effects are larger than those of fenofibrate (19% 22% and 14% respectively). Fenofibrate decreased very-low-density lipoprotein and TG, and increased high-density lipoprotein and apo Al, to a larger extent than simvast