A pilot trial of fenofibrate for the treatment of non-alcoholic fatty liver disease

Dig Liver Dis. 2008 Mar;40(3):200-5. doi: 10.1016/j.dld.2007.10.002.

Abstract

Background: Dyslipidaemia and insulin resistance are two important risk factors for non-alcoholic fatty liver disease. Both factors can improve with fenofibrate.

Aims: To evaluate the effect of fenofibrate on the clinical, analytical and histological evolution of patients with non-alcoholic fatty liver disease.

Subjects and methods: Sixteen consecutive patients with biopsy-confirmed non-alcoholic fatty liver disease were treated with 200mg/day of fenofibrate for 48 weeks. A clinical and biochemical follow-up was done every 3 months. A new liver biopsy was performed in all patients at the end of therapy.

Results: All patients completed 48 weeks of therapy with fenofibrate, without adverse events. At the end of the study, a significant decrease in triglyceride, glucose, alkaline phosphatase and gamma-glutamyl transpeptidase and an increase of apolipoprotein A1 levels were found. Insulin levels and insulin resistance showed a trend to decrease. Moreover, a reduction in the proportion of patients with abnormal aminotransferase levels (>45IU/L) was observed (alanine aminotransferase: 93.7% vs. 62.5%, p=0.02; aspartate aminotransferase: 50% vs. 18.7%, p=0.02). The body mass index did not show any significant change, but the proportion of patients with metabolic syndrome decreased significantly (43.7% vs. 18.7%, p=0.04). A control biopsy after treatment revealed a decrease in the grade of hepatocellular ballooning degeneration (p=0.03), but the grade of steatosis, lobular inflammation, fibrosis or non-alcoholic fatty liver disease activity score did not change significantly.

Conclusions: In patients with non-alcoholic fatty liver disease, treatment with fenofibrate is safe and improves metabolic syndrome, glucose and liver tests. However, its effects on liver histology are minimal.

Publication types

  • Clinical Trial
  • Comparative Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Alkaline Phosphatase / blood
  • Apolipoprotein A-I / blood
  • Biopsy, Needle
  • Dose-Response Relationship, Drug
  • Fatty Liver / drug therapy*
  • Fatty Liver / metabolism
  • Fatty Liver / pathology
  • Female
  • Fenofibrate / therapeutic use*
  • Follow-Up Studies
  • Humans
  • Hypolipidemic Agents / therapeutic use*
  • Liver / drug effects
  • Liver / metabolism
  • Liver / pathology
  • Male
  • Pilot Projects
  • Retrospective Studies
  • Transaminases / blood
  • Treatment Outcome
  • Triglycerides / blood
  • gamma-Glutamyltransferase / blood

Substances

  • Apolipoprotein A-I
  • Hypolipidemic Agents
  • Triglycerides
  • gamma-Glutamyltransferase
  • Transaminases
  • Alkaline Phosphatase
  • Fenofibrate