Fenofibrate for the treatment of type IV and V hyperlipoproteinemias: a double-blind, placebo-controlled multicenter US study.
The results of a randomized, double-blind, placebo-controlled multicenter trial of fenofibrate in the treatment of type IV/V hyperlipoproteinemia are reported. Ten study centers in the United States recruited 147 adults with a history of type IV or V hyperlipoproteinemia. After a six- to 12-week dietary stabilization period and a four-week placebo period, patients whose 12-hour fasting total plasma triglyceride levels ranged from 350 to 1,500 mg/dl were continued in the study; 55 patients with levels of 350 to 499 mg/dl were placed in group A and 92 with levels of 500 to 1,500 mg/dl in group B. Patients in each group were randomly assigned to receive 100 mg of fenofibrate or placebo three times daily for eight weeks. In both groups A and B fenofibrate-treated patients showed statistically significant reductions in levels of total cholesterol, very-low-density lipoprotein cholesterol, total triglycerides, and very-low-density lipoprotein triglycerides, and significant increases in high-density lipoprotein cholesterol; patients in group B also showed a significant increase in low-density lipoprotein cholesterol levels. Sixteen of the 75 fenofibrate-treated patients and 11 of the 72 placebo patients reported adverse events that were potentially drug related; most of these were gastrointestinal and a few reported musculoskeletal and skin reactions. It is concluded that fenofibrate is an effective and safe agent in the treatment of type IV/V hyperlipoproteinemia.
Goldberg
A C
AC
Washington University, St. Louis, Missouri.
Schonfeld
G
G
Feldman
E B
EB
Ginsberg
H N
HN
Hunninghake
D B
DB
Insull
W
W
Knopp
R H
RH
Kwiterovich
P O
PO
Mellies
M J
MJ
Pickering
J
J
D000293:Adolescent; D000328:Adult; D000368:Aged; D002784:Cholesterol / Q000097:blood; D002986:Clinical Trials as Topic; D004311:Double-Blind Method; D005260:Female; D011345:Fenofibrate / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D006953:Hyperlipoproteinemia Type IV / Q000188:drug therapy*; D006954:Hyperlipoproteinemia Type V / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D011422:Propionates / Q000627:therapeutic use*; D011897:Random Allocation; D013997:Time Factors; D014280:Triglycerides / Q000097:blood; D014481:United States
D011422:Propionates; D014280:Triglycerides; D002784:Cholesterol; D011345:Fenofibrate