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Lubiprostone Reduces Fat Content on MRI-PDFF in Patients With MASLD: A 48-Week Randomised Controlled Trial.

Mohamed El-Kassas^1,2,3, Hala Mostafa¹, Wessam Abdellatif⁴

¹Endemic Medicine Department, Faculty of Medicine, Helwan University, Cairo, Egypt.

Alimentary Pharmacology & Therapeutics

|January 2, 2025

Summary

Lubiprostone treatment for 48 weeks significantly reduced liver fat in patients with metabolic dysfunction-associated steatotic liver disease (MASLD). This study suggests lubiprostone is a promising therapeutic option for MASLD, with good tolerability.

Keywords:

lubiprostone magnetic resonance imaging estimated proton density fat fraction metabolic dysfunction‐associated steatotic liver disease randomised placebo‐controlled trial

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Area of Science:

Hepatology
Gastroenterology
Pharmacology

Background:

Metabolic dysfunction-associated steatotic liver disease (MASLD) is a growing health concern.
Current treatment options for MASLD are limited.
Lubiprostone, a laxative, has demonstrated effects on intestinal permeability.

Purpose of the Study:

To evaluate the safety and efficacy of lubiprostone in patients with MASLD.
To assess the impact of 48-week lubiprostone administration on liver fat content.

Main Methods:

A 48-week randomized placebo-controlled trial was conducted.
116 eligible patients with MASLD were randomized to receive either placebo or lubiprostone (24 μg twice daily).
Liver fat content was quantified using MRI-PDFF; fibrosis and ALT levels were also assessed.

Main Results:

Lubiprostone significantly reduced liver fat content compared to placebo (p=0.04).
No significant differences were observed in fibrosis scores or ALT levels between groups.
One patient experienced severe diarrhea, leading to treatment discontinuation; otherwise, lubiprostone was well-tolerated.

Conclusions:

Lubiprostone effectively reduced liver fat in MASLD patients over 48 weeks.
The treatment was well-tolerated, with minimal adverse events.
Further extensive studies are warranted to confirm lubiprostone's efficacy in treating MASLD.