| Title: |
norUrsodeoxycholic acid improves cholestasis in primary sclerosing cholangitis |
| Authors: |
Fickert, P; Hirschfield, G; Denk, G; Marschall, H; Altorjay, I; Färkkilä, M; Schramm, C; Spengler, U; Chapman, R; Bergquist, A; Schrumpf, E; Nevens, F; Trivedi, P; Reiter, F; Tornai, I; Halilbasic, E; Greinwald, R; Pröls, M; Manns, M; Trauner, M; Group, European Psc Norudca Study |
| Publisher Information: |
Elsevier |
| Publication Year: |
2019 |
| Collection: |
Oxford University Research Archive (ORA) |
| Description: |
Background & Aim Primary sclerosing cholangitis (PSC) represents a devastating bile duct disease, currently lacking effective medical therapy. 24-norursodeoxycholic acid (norUDCA) is a side chain-shortened C23 homologue of UDCA and has shown potent anti-cholestatic, anti-inflammatory and anti-fibrotic properties in a preclinical PSC mouse model. A randomized controlled trial, including 38 centers from 12 European countries, evaluated the safety and efficacy of three doses of oral norUDCA (500 mg/d, 1,000 mg/d or 1,500 mg/d) compared with placebo in patients with PSC. Methods One hundred sixty-one PSC patients without concomitant UDCA therapy and with elevated serum alkaline phosphatase (ALP) levels were randomized for a 12-week treatment followed by a 4-week follow-up. The primary efficacy endpoint was the mean relative change in ALP levels between baseline and end of treatment visit. Results norUDCA reduced ALP levels by −12.3%, −17.3%, and −26.0% in the 500, 1,000, and 1,500 mg/d groups (p = 0.029, p = 0.003, and p |
| Document Type: |
article in journal/newspaper |
| Language: |
English |
| Relation: |
https://doi.org/10.1016/j.jhep.2017.05.009 |
| DOI: |
10.1016/j.jhep.2017.05.009 |
| Availability: |
https://doi.org/10.1016/j.jhep.2017.05.009; https://ora.ox.ac.uk/objects/uuid:8a82ad46-7070-46f2-bf70-23d149e84a68 |
| Rights: |
info:eu-repo/semantics/openAccess ; CC Attribution-NonCommercial-NoDerivatives (CC BY-NC-ND) |
| Accession Number: |
edsbas.BD5CE608 |
| Database: |
BASE |