Safety and Efficacy of Long-Term Pioglitazone in Patients with NASH and Prediabetes or Diabetes

Most previous studies of pharmacotherapies for nonalcoholic steatohepatitis (NASH) were short-term and conducted in populations without diabetes.

In the current industry-supported, single-center, randomized, controlled trial, researchers assessed the efficacy and safety of long-term pioglitazone therapy in improving histologic outcomes in patients with biopsy-proven NASH and either prediabetes or type 2 diabetes mellitus. Patients were randomized to receive daily pioglitazone (30 mg initially, then titrated to 45 mg) or placebo for 18 months, along with dietary counseling. Patients without resolution after 18 months could continue or start pioglitazone for an additional 18 months (open-label phase). The primary endpoint was reduction of ≥2 p…