Efficacy and tolerance of 200 mg micronised fenofibrate administered over a 6-month period in hyperlipidaemic patients: an open Belgian multicenter study.

ABSTRACT

The authors report the results of a large open multicenter study using 200 mg micronised fenofibrate once a day. Among 1545 selected patients who underwent a 3-month period with nutritional advice, 1334 were included in a 6-month drug study. Inclusion criteria were total serum cholesterol equal to or above 250 mg/dl and/or serum triglycerides equal to or above 200 mg/dl. At 6 months, average changes from inclusion levels were -20.5, -26.1. -7.5 and +15.2% for total cholesterol, LDL-cholesterol > or = 160 mg/dl on inclusion, plasma fibrinogen and HDL-cholesterol, respectively. Median decrease of serum triglycerides was 46.5%. Trial discontinuation for clinical and biological adverse events were 5 and 1%, respectively. In conclusion, micronised fenofibrate at a daily dose of 200 mg had significant lipid-modifying properties but also exhibited a beneficial effect on other related risk factors such as fibrinogen reduction. The safety profile was very satisfactory providing an excellent benefit/risk ratio.