223-OR: Pioglitazone Discontinuation in Patients with Nonalcoholic Steatohepatitis (NASH) Is Associated with Disease Recurrence

Pioglitazone (PIO) therapy results in a ∼60% resolution of NASH in patients with prediabetes or T2DM. However, the effects of treatment discontinuation have not been carefully examined. To this end, we assessed plasma aminotransferases (LFTs) after study drug discontinuation among patients who had completed 36 months (n=63) of our randomized, controlled trial (RCT) of PIO for NASH (Cusi, et al. Ann Intern Med 2016). This was an 18 month RCT of PIO 45mg QD vs. placebo (and dietary counseling in all), followed by 18 months of open label PIO. We retrospectively assessed LFTs for 18 months following study discontinuation. PIO normalized plasma ALT, an indicator of hepatocyte injury in NASH, within 3 months of therapy initiation (from 61±5 to 35±2 U/L; p