Lubiprostone effective in patients with NAFLD with constipation: Study

According to the latest study, Lubiprostone was well tolerated in non-alcoholic fatty liver disease patients with constipation. It also reduced the liver enzymes in them. The recent study was published in the journal, "The Lancet Gastroenterology & Hepatology" 2020.

Lubiprostone is a bicyclic fatty acid compound derived from a metabolite of prostaglandin E1. It is a laxative drug that improves intestinal permeability. Non-alcoholic fatty liver disease comprises deposition of adipose tissue in the liver leading to progressive steatosis, hepatitis, fibrosis, cirrhosis, and hepatocellular carcinoma. Researchers from Japan conducted a study to assess the efficacy and safety of lubiprostone in patients with non-alcoholic fatty liver disease (NAFLD) with constipation via attenuation of intestinal permeability.

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The study was conducted in Yokohama City University Hospital, Japan between March 24, 2017, and April 3, 2018. The study was a randomized, double-blind, placebo-controlled, phase 2a trial. Patients aged 20-85 years with non-alcoholic fatty liver disease and constipation and having alanine aminotransferase (ALT) at least 40 U/L, liver stiffness (≤6·7 kPa), and a hepatic fat fraction of at least 5·2% (as assessed by MRI-proton density fat fraction) were taken into the study. The randomisation of eligible patients was done by a computer-generated system. After stratification by age and sex, the participants received 24 μg lubiprostone, 12 μg lubiprostone, or placebo, orally, once per day for 12 weeks. The primary endpoint was the absolute changes in ALT at 12 weeks. Efficacy analysis was done by intention to treat and safety was assessed in all treated patients.