Pioglitazone safe, effective in NASH treatment

Pioglitazone was safe and effective in improving liver histology among patients with nonalcoholic steatohepatitis, according to a presenter at the Digital NAFLD Summit 2021.

“Fatty liver disease is the most prevalent liver disease globally and it’s of particular importance in Asia-Pacific due to the rapid westernization,” Jee-Fu Huang, Kaohsiung Medical University Hospital, said. “Insulin resistance is the key player in NASH independent of obesity and visceral adiposity. The therapeutic efficacy and safety of pioglitazone (PGT), a PPARy agonist, deserves validation in Asian NASH patients.”

In a first-in-Asia, double-blind, placebo-controlled study, researchers evaluated 90 patients with NASH (66 men; mean age, 44.1 years) to investigate the safety and effectiveness of PGT. Patients received either PGT 30 mg per day or placebo for 24 weeks and underwent paired biopsies and MRI-PDFF examinations.

Among patients treated with PGT, researchers observed decreased mean alanine aminotransferase levels compared with baseline (approximately 45.7 IU/L vs. 90 IU/L); there was no significant change to ALT levels among patients treated with placebo (approximately 79.8 IU/L vs. 90.3 IU/L). Further intention-to-treat analysis (n = 66 patients) yielded a more significant decrease in NAFLD activity score among the PGT group vs. the placebo group (4.27 to 2.53 vs. 3.94) with improved NASH without fibrosis worsening achieved in 46.7% and 11.1% of patients, respectively. Researchers noted no difference in adverse event occurrence between groups.

“PGT therapy significantly improved liver inflammation and reduced liver fat in Taiwanese NASH patients. PGT was well-tolerated, and the safety profile was acceptable without significant weight gain and heart failure development,” Huang concluded. “Further study addressing the long-term outcome and the exploration of combining with other drugs may be needed.”