Ezetimibe not effective in treating NASH
the Clinical Advisor take:
Compared with placebo, ezetimibe did not perform better for reducing liver fat and improving liver histology in nonalcoholic steatohepatitis (NASH), according to a study published in Hepatology.
These results are from the Magnetic Resonance Imaging and Elastography in Ezetimibe Verses Placebo for the Assessment of Response to Treatment in NASH (MOZART) trial.
Previous uncontrolled ultrasound studies had suggested that ezetimibe may improve hepatic steatosis, reduce serum alanine aminotransferase (ALT), and improve histological features of NASH. However, the results of this study indicate that ezetimibe did not significantly reduce liver fat.
The MOZART trial included 50 patients from the San Diego Integreated NAFLD Research Consortium cohort. Each participant had biopsy-proven NASH and was randomized to receive either 10mg of oral ezetimibe daily or place for 24 weeks. The primary outcome was a change in liver fat measured by MRI-PDFF in colocalized ROIs within each of the nine liver segments.
The researchers used an MRI-derived biomarker, proton density-fat fraction (MRI-PDFF), to measure reductions in liver fat. They confirmed their results by using co-localized magnetic resonance spectroscopy (MRS) and liver histology.
The researchers also measured 2- and 3-dimensional magnetic resonance elastography (2D/3D MRE)-derived reductions in liver stiffness, which provides other researchers with a new technique to use in further research.
Despite not finding a treatment for NASH, the researchers are hopeful that their new techniques can be utilized in future research. "Future studies, especially [those] that target antifibrotic mechanisms, may utilize the MRE protocol used in this trial as a proof of concept for noninvasive and quantitative assessment of treatment response,” said researcher Rohit Loomba, MD, of the University of California at San Diego School of Medicine.
Ezetimibe did reduce liver fat, but it was not clinically significant.
Ezetimibe was no better than placebo at reducing liver fat or improving liver histology in nonalcoholic steatohepatitis (NASH), results of the MOZART (Magnetic Resonance Imaging and Elastography in Ezetimibe Versus Placebo for the Assessment of Response to Treatment in NASH) trial showed.
"This trial ... provides compelling evidence that ezetimibe has no specific role in the treatment of NASH," Rohit Loomba, MD, division of gastroenterology and epidemiology, University of California at San Diego School of Medicine, La Jolla, Calif., and colleagues reported in Hepatology.