Fenofibrate for the treatment of type IV and V hyperlipoproteinemias: A double-blind placebo-controlled multicenter US study

A. C. Goldberg, G. Schonfeld, E. B. Feldman, H. N. Ginsberg, D. B. Hunninghake, W. Insull, R. H. Knopp, P. O. Kwiterovich, M. J. Mellies, J. Pickering, P. Samuel

Research output: Contribution to journalArticlepeer-review

46 Scopus citations

Abstract

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 ml/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.

Original languageEnglish
Pages (from-to)69-83
Number of pages15
JournalClinical therapeutics
Volume11
Issue number1
StatePublished - May 24 1989
Externally publishedYes

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