BOSTON — Oltipraz significantly reduced liver fat and BMI in patients with non-alcoholic fatty liver disease without increased adverse events including worsening of liver fibrosis, and was well-tolerated, according to data presented at The Liver Meeting.
“Oltipraz is a synthetic dithiolethione and functions as an antisteatotic agent against NAFLD by inhibiting the activity of liver X receptor alpha,” Won Kim, MD, department of internal medicine and Liver Research Institute, Seoul National University Boramae Medical Center, said in a presentation. “The aim of this study was to evaluate the efficacy and safety of oltipraz for reducing liver fat in subjects with NAFLD.”
Kim and colleagues performed a multicenter, double-blind phase 2 study of patients with greater than 20% liver fat content and elevated aminotransferase levels. Participants were randomly assigned to receive placebo (n=22), or oltipraz 30 mg (n=22) or 60 mg (n=24) twice daily for a 24 week treatment period. Change in liver fat content through the study period was measured by magnetic resonance spectroscopy, and changes in BMI, liver enzymes, lipids, insulin resistance, cytokines, and NAFLD fibrosis and activity scores were also measured.
Absolute reductions in liver fat content corresponded to oltipraz dose, with –3.21%±11.09% in the placebo group, –7.65%±6.98% in the 30 mg group and –13.91%±10.65% in the 60 mg group. The percentage of reductions in liver fat, BMI and fibrosis scores were also significantly greater in the 60 mg group compared with placebo. Adverse event incidence was similar throughout groups.
“In conclusion, 24-week oltipraz treatment was well tolerated and significantly reduced liver fat amount and BMI without worsening of liver fibrosis in patients with NAFLD,” Kim said.
For more information:
Kim W. Abstract 55. Presented at: The Liver Meeting, Nov. 7-11, 2014; Boston, MA.
Disclosure: Kim reports financial ties to PharmaKing.