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.

The key findings of the study were:

• Out of 288 patients, 150 were randomly assigned to treatment.

• 55 patients were assigned to receive 24 μg lubiprostone, 50 to receive 12 μg lubiprostone, and 45 to receive a placebo.

• A greater decrease in the absolute ALT levels from baseline to 12 weeks was seen in the 24 μg lubiprostone group than in the placebo group and in the 12 μg lubiprostone group than in the placebo group.

• 18 (33%) of 55 patients in the 24 μg group had at least one adverse event, as did three (6%) of 47 patients in the 12 μg group and three (7%) of 43 in the placebo group.

• The most common adverse event was diarrhea seen in 17 [31%] of patients in the 24 μg group, three [6%] in the 12 μg group, and none in the placebo group.

• No life-threatening events or treatment-related deaths occurred.

Thus, the researchers concluded that Lubiprostone was well tolerated and reduced the levels of liver enzymes in patients with NAFLD and constipation. They also suggested Further studies to better define the efficacy and tolerability of lubiprostone in patients with NAFLD without constipation. 

For further reading, click the following link: https://doi.org/10.1016/S2468-1253(20)30216-8