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/m2), 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 A1c, 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.