Resmetirom and obeticholic acid for non-alcoholic steatohepatitis (NASH): final evidence report

Resmetirom and obeticholic acid for non-alcoholic steatohepatitis (NASH): final evidence report

Collection:
Health Policy and Services Research
Author(s):
Tice, Jeffrey A., author
Fahim, Shahariar Mohammed, author
Richardson, Marina, author
Herce-Hagiwara, Belen, author
Chu, Janet N., author
Pearson, Steven D., author
Rind, David M., author
Suh, Kangho, author
Carlson, Josh, author
Dickerson, Ronald, author
Contributor(s):
Institute for Clinical and Economic Review, issuing body.
Midwest Comparative Effectiveness Public Advisory Council, issuing body.
Publication:
[Boston, Massachusetts] : Institute for Clinical and Economic Review, May 25, 2023
Language(s):
English
Format:
Text
Subject(s):
Chenodeoxycholic Acid -- analogs & derivatives
Liver Cirrhosis -- drug therapy
Non-alcoholic Fatty Liver Disease -- drug therapy
Pyridazines
Uracil -- analogs & derivatives
United States
Genre(s):
Technical Report
Abstract:
Two oral medications are currently being evaluated as treatments for NASH with fibrosis. Resmetirom (RES) is a small molecule agonist for the thyroid hormone receptor beta (THR-beta). Obeticholic Acid (OCA) is a bile acid analog that was approved for the treatment of patients with primary biliary cholangitis (PBC) in 2016. Topline data from a phase 3 trial found that more patients treated with resmetirom 80 mg or 100 mg than placebo had ≥ 1 stage improvement in fibrosis without worsening of NASH (24% and 26% vs. 14%) and more had NASH resolution without worsening of fibrosis (26% and 30% vs. 10%). The most frequent adverse event was diarrhea (28% to 34% vs. 16% placebo); LDL-cholesterol decreased with resmetirom compared with placebo.4 More patients treated with OCA 25 mg for 18 months than placebo had achieved ≥ 1 stage improvement in fibrosis without worsening of NASH (22% vs. 10%) without significant differences between groups in NASH resolution without worsening of fibrosis.
Copyright:
Reproduced with permission of the copyright holder. Further use of the material is subject to CC BY license. (More information)
Extent:
1 online resource (1 PDF file (various pagings))
Illustrations:
Illustrations
NLM Unique ID:
9918697384206676 (See catalog record)
Permanent Link:
http://resource.nlm.nih.gov/9918697384206676