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

BackgroundDyslipidaemia and insulin resistance are two important risk factors for non-alcoholic fatty liver disease. Both factors can improve with fenofibrate.AimsTo evaluate the effect of fenofibrate on the clinical, analytical and histological evolution of patients with non-alcoholic fatty liver disease.Subjects and methodsSixteen 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.ResultsAll 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 (>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.ConclusionsIn 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.