A Pilot Study of Pioglitazone for the Treatment of Non-Alcoholic Fatty Liver Disease

Background and Aims: Insulin resistance appears to be a major factor involved in the pathogenesis of non-alcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH). In this pilot study, we examined the effect of pioglitazone, an insulin-sensitizing agent, on patients with NAFLD and NASH.

Methods: The medical records of patients referred to our clinic over a 48-month period were reviewed, and individuals with a clinical diagnosis of NAFLD or NASH, who were overweight (BMI|"|25) with chronic elevated liver enzymes were included in this study. The patients were either treated with pioglitazone or advised to start a weight-reduction diet and exercise, in a non-blinded random method based on the treating physicians' discretion.

Results: Thirty-four patients' charts were retrospectively analyzed. Nineteen patients were treated with pioglitazone and 15 patients were advised to start a weight reduction diet and exercise. There were significant improvements in mean ALT and AST in the pioglitazone group at the end of treatment when compared to pretreatment values and to the diet/exercise group. There were no significant changes in the lipid profiles, body mass index or fasting glucose levels between baseline and at the end of the therapy in either group. There were no adverse side effects, including hypoglycemia, in patients treated with pioglitazone. 

Conclusions: Preliminary results using pioglitazone in patients with NAFLD or NASH are promising. However, larger prospective studies are further needed to validate the results of our study and to examine histological response.