Pioglitazone Is Safe, Effective for Diabetes With NASH

Long-term use of pioglitazone improves outcomes in patients with prediabetes or type 2 diabetes and nonalcoholic steatohepatitis (NASH), according to a recent study.

The effects of long-term use of pioglitazone in this patient population are not well understood. Therefore, the researchers aimed to determine the efficacy and safety of long-term treatment.
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To conduct their study, the researchers recruited 101 patients with prediabetes or type 2 diabetes and biopsy-proven NASH from the general population and outpatient clinics.

Patients consumed a reduced-calorie diet and were randomly assigned 45 mg/d of pioglitazone or a placebo for 18 months, followed by an open-label phase with pioglitazone treatment.

About 58% of patients assigned to pioglitazone reduced their nonalcoholic fatty liver disease activity score by at least 2 points without worsening fibrosis, and 51% saw a resolution of NASH.

When compared with placebo, pioglitazone also improved fibrosis; reduced hepatic triglyceride content from 19% to 7%; and improved adipose tissue, hepatic, and muscle insulin sensitivity.

Adverse effects were similar between groups, but patients taking pioglitazone had more weight gain than those taking placebo.

“Long-term pioglitazone treatment is safe and effective in patients with prediabetes or [type 2 diabetes] and NASH,” the researchers concluded.

—Amanda Balbi

Reference:

Cusi K, Orsak B, Bril F, et al. Long-term pioglitazone treatment for patients with nonalcoholic steatohepatitis and prediabetes or type 2 diabetes mellitus: a randomized, controlled trial [published online June 21, 2016]. Ann Intern Med. doi:10.7326/M15-1774.