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Comment
. 2017 Feb;41(1):3-5.
doi: 10.1016/j.clinre.2016.09.006. Epub 2016 Nov 4.

Obeticholic acid in primary biliary cholangitis

Serge Erlinger  1
Affiliations
Comment

Obeticholic acid in primary biliary cholangitis

Serge Erlinger. Clin Res Hepatol Gastroenterol. 2017 Feb.

Abstract

In a double-blind, randomized, placebo-controlled study including 217 patients with primary biliary cholangitis, the authors show that obeticholic acid (a potent farnesoid X agonist) administered with ursodeoxycholic acid or as monotherapy significantly decreases serum alkaline phosphatase and bilirubin when compared to placebo. Pruritus (and serious adverse effects) was observed more frequently in obeticholic acid-treated patients than in controls, in spite of a decrease in serum bile acid concentration. These results are encouraging, but more studies are needed on clinical efficacy and safety before obeticholic acid can be widely recommended.

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  • A Placebo-Controlled Trial of Obeticholic Acid in Primary Biliary Cholangitis.
    Nevens F, Andreone P, Mazzella G, Strasser SI, Bowlus C, Invernizzi P, Drenth JP, Pockros PJ, Regula J, Beuers U, Trauner M, Jones DE, Floreani A, Hohenester S, Luketic V, Shiffman M, van Erpecum KJ, Vargas V, Vincent C, Hirschfield GM, Shah H, Hansen B, Lindor KD, Marschall HU, Kowdley KV, Hooshmand-Rad R, Marmon T, Sheeron S, Pencek R, MacConell L, Pruzanski M, Shapiro D; POISE Study Group. Nevens F, et al. N Engl J Med. 2016 Aug 18;375(7):631-43. doi: 10.1056/NEJMoa1509840. N Engl J Med. 2016. PMID: 27532829 Clinical Trial.

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