The long-term efficacy and safety of fluvastatin monotherapy was compared with that of the combination of fluvastatin and fenofibrate in 104 patients with coronary heart disease and combined hyperlipidemia in an open, randomised, parallel group, clinical study of 78 weeks duration. Combined hyperlipidemia was defined as LDL-cholesterol 4.1 mmol/l and higher and triglycerides between 2.5 and 4.5 mmol/l after 8 weeks of dietary intervention. The patients were treated with either fluvastatin 40 mg daily or with the combination of fluvastatin (20 mg daily) and micronized fenofibrate 200 mg daily. Mean values of total and LDL-cholesterol decreased by 19.3% and 29.7% respectively after fluvastatin treatment and by 21.5% and 29.1% respectively after the combination of fluvastatin and fenofibrate treatment. The differences between the treated groups were not significant. Mean values of HDL-cholesterol increased significantly more after the combination of fluvastatin and fenofibrate than after fluvastatin monotherapy (26% vs. 9.9%). The mean values of triglycerides decreased significantly more after the combination treatment than after fluvastatin monotherapy (-40.2% vs. -19.7%). The treatment in both groups was well tolerated and no signs of myopathy were observed in any patient. The study was discontinued in 1 patient due to the increase of liver enzymes. The most frequently observed side effects were minor gastrointestinal symptoms, which were more frequent in patients treated by the combination of fluvastatin and fenofibrate. Thus our results demonstrate that the combination of fluvastatin and fenofibrate is an effective and safe treatment option for patients with coronary heart disease and mild to moderate combined hyperlipidemia if a more radical lowering of triglycerides and increase of HDL-cholesterol is desired.

Keywords: Adult; Aged; Coronary Disease /complications/; Drug Therapy, Combination; Fatty Acids, Monounsaturated /administration & dosage/; Female; Fenofibrate /administration & dosage/; Fluvastatin; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors /administration & dosage/; Hyperlipidemias /complications/; Hypolipidemic Agents /administration & dosage/; Indoles /administration & dosage/; Male; Middle Aged