VIENNA — Amitiza was tolerable and improved hepatic markers among patients with nonalcoholic fatty liver disease, according to data presented at the International Liver Congress 2019.
“Lubiprostone (Amitiza, Takeda) is a chloride channel activator approved for the treatment of chronic constipation,” Takaomi Kessoku, MD, of Yokohama City University in Japan said during his presentation. “Previous human studies have shown that lubiprostone ameliorated gut-permeability induced by NSAIDS in healthy volunteers.”
Kessoku and colleagues enrolled 150 patients with NAFLD in the randomized control trial. Patients received 12 g of lubiprostone (n = 47), 24 g of the therapeutic (n = 51), or placebo (n = 41) for 12 weeks.
After 12 weeks of treatment, patients who received 12 g of lubiprostone (P = .0096) and 24 g of lubiprostone (P = .0025) showed significant improvements in mean alanine aminotransferase compared with placebo.
Compared with placebo, treated patients also had significant improvements in lactulose-mannitol ratio (12 g, P = .0125; 24 g, P = .0017), blood endotoxin activity (12 g, P = .0008; 24 g, P = .0002), MRI-PDFF (12 g, P < .001; 24 g, P = .001) and liver stiffness (12 g, P = .0207; 24 g, P = .0002).
In the safety and tolerability analysis, 5% of patients in the placebo group, 0% in the 12 g lubiprostone group, and 9% in the 24 g group had dropped out of the study, which “showed that 24 g of lubiprostone had significantly higher rates of adverse events,” Kessoku said (P = .0025), especially diarrhea compared with the other groups.
“These results suggest that manipulating gut permeability may be a promising novel treatment target for the treatment of NAFLD.” – by Talitha Bennett
Kessoku T. Abstract GS-01. Presented at: International Liver Congress; April 10-14, 2019; Vienna, Austria.
Disclosures: Kessoku reports financial connections with Mylan EPD.