Efficacy and tolerance of 200 mg micronised fenofibrate administered over a 6-month period in hyperlipidaemic patients: an open Belgian multicenter study.
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.
Laboratory of Epidemiology and Social Medicine, School of Public Health, Free University of Brussels, Belgium.
M
M
Kornitzer
M
M
Dramaix
M D
MD
Vandenbroek
L
L
Everaert
C
C
Gerlinger
D000293:Adolescent; D000328:Adult; D000368:Aged; D001530:Belgium; D002784:Cholesterol / Q000097:blood; D008076:Cholesterol, HDL / Q000097:blood; D008078:Cholesterol, LDL / Q000097:blood; D004339:Drug Compounding; D004361:Drug Tolerance; D005260:Female; D011345:Fenofibrate / Q000494:pharmacology / Q000627:therapeutic use*; D006801:Humans; D006949:Hyperlipidemias / Q000097:blood / Q000188:drug therapy*; D006938:Hyperlipoproteinemia Type II / Q000097:blood / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged
D008076:Cholesterol, HDL; D008078:Cholesterol, LDL; D002784:Cholesterol; D011345:Fenofibrate