Long-Term Pioglitazone Treatment for Patients With Nonalcoholic Steatohepatitis and Prediabetes or Type 2 Diabetes Mellitus: A Randomized, Controlled Trial

In this RCT (n=101) investigating pioglitazone (P) v placebo, at 18months those receiving P were more likely to achieve the primary endpoint of reduction of at least 2 points in non-alcoholic fatty liver disease activity score without a worsening of fibrosis (58% vs 17%; P<0.001)

Extending treatment to 36 months did not result in any additional improvement beyond that seen after 18 months, the study found. The overall rate of adverse events did not differ between the two groups, although weight gain was greater with pioglitazone.

 

In a related editorial, the authors comment “We believe that physicians should consider adding pioglitazone to their toolboxes when facing patients with non-alcoholic steatohepatitis and diabetes, but the primary obstacle to the widespread use of pioglitazone remains its safety profile. Thus, treatment should be considered for patients at the greatest risk (those with non-alcoholic steatohepatitis and fibrosis) and should be balanced against the common risk for weight gain and the uncommon risks for fracture and heart failure.”