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

par Kornitzer, Marcel ;Dramaix Wilmet, Michèle ;Vandenbroek, M.D.;Everaert, L.;Gerlinger, C.
Référence Atherosclerosis. Supplement, 110, page (49-54)
Publication Publié, 1994

Article révisé par les pairs

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Résumé :

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 >- 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. © 1994 Elsevier Science Ireland Ltd. All rights reserved.