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

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 200 mg/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 A I 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 (>45 IU/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. (c) 2007 Published by Elsevier Ltd on behalf of Editrice Gastroenterologica Italiana S.r.l.