Rosiglitazone treatment in nondiabetic subjects with nonalcoholic fatty liver disease.

Introduction Pharmacological treatment options for nonalcoholic fatty liver disease (NAFLD) are limited. It has been suggested that thiazolidinediones may be useful in NAFLD treatment. Objectives An open-label prospective study was conducted to assess the efficacy and safety of rosiglitazone treatment in nondiabetic subjects with NAFLD. Patients and methods A total of 27 subjects (mean age 44 +/- 11 years, body mass index 29.2 +/- 3.1 kg/m(2)), with biopsy-confirmed NAFLD and no other complaints, were treated with rosiglitazone 4 mg daily for 6 months. Results No adverse events were observed during a 6-month treatment with rosiglitazone. Liver enzymes gradually decreased (alanine transaminase from 101 +/- 59 to 58 +/- 39 IU/l, aspartate transaminase from 52 +/- 24 to 37 +/- 15 IU/l; P < 0.001). Plasma insulin levels decreased significantly by 30% to 50% in each time point of the oral glucose tolerance test. The homeostatic model assessment index decreased from 3.73 +/- 1.89 to 2.06 +/- 1.68 (P < 0.001). No significant changes in plasma glucose were noted. Plasma adiponectin increased from 2198 +/- 1853 to 5734 +/- 1999 ng/ml (P < 0.001). There were no statistically significant changes in body weight, glycated hemoglobin A(1c), plasma lipids, or leptin. Conclusions Rosiglitazone treatment in patients with NAFLD is safe, well-tolerated and leads to a significant improvement in liver function and insulin sensitivity, without adversely affecting the lipid profile.