A Placebo-Controlled Trial of Obeticholic Acid in Primary Biliary Cholangitis.

Vincent, Catherine; Nevens, Frederik; Andreone, Pietro; Mazzella, Giuseppe; Strasser, Simone I.; Bowlus, Christopher L.; Invernizzi, Pietro; Drenth, Joost P H; Pockros, Paul J; Regula, Jaroslaw; Beuers, Ulrich; Trauner, Michael; Jones, David E H; Floreani, Annarosa; Hohenester, Simon; Luketic, Velimir; Shiffman, Mitchell L.; van Erpecum, Karel J; Vargas, Víctor J.; Hirschfield, Gideon M.; Shah, Hemant; Hansen, Bettina; Lindor, Keith D.; Marschall, Hanns-Ulrich; Kowdley, Kris V; Hooshmand-Rad, Roya; Marmon, Tonya; Sheeron, Shawn; Pencek, Richard; MacConell, Leigh; Pruzanski, Mark; Shapiro, David

doi:10.1056/NEJMoa1509840

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A Placebo-Controlled Trial of Obeticholic Acid in Primary Biliary Cholangitis.

Author(s): Catherine Vincent, Frederik Nevens, Pietro Andreone, Giuseppe Mazzella, Simone I. Strasser, Christopher Bowlus, Pietro Invernizzi, Joost P H Drenth, Paul Pockros, Jaroslaw Regula, Ulrich Beuers, Michael Trauner, David E H Jones, Annarosa Floreani, Simon Hohenester, Velimir Luketic, Mitchell L. Shiffman, Karel J van Erpecum, Víctor J. Vargas, Gideon Hirschfield, Hemant Shah, Bettina Hansen, Keith D. Lindor, Hanns-Ulrich Marschall, Kris V Kowdley, Roya Hooshmand-Rad, Tonya Marmon, Shawn Sheeron, Richard Pencek, Leigh MacConell, Mark Pruzanski, David Shapiro

Publication date: 2016-08-18

Journal: The New England journal of medicine

Publisher: New England Journal of Medicine (NEJM/MMS)

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Abstract

Primary biliary cholangitis (formerly called primary biliary cirrhosis) can progress to cirrhosis and death despite ursodiol therapy. Alkaline phosphatase and bilirubin levels correlate with the risk of liver transplantation or death. Obeticholic acid, a farnesoid X receptor agonist, has shown potential benefit in patients with this disease.