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Seladelpar efficacy and safety at 3 months in patients with primary biliary cholangitis: ENHANCE, a phase 3, randomized, placebo-controlled study.
Hirschfield GM, Shiffman ML, Gulamhusein A, Kowdley KV, Vierling JM, Levy C, Kremer AE, Zigmond E, Andreone P, Gordon SC, Bowlus CL, Lawitz EJ, Aspinall RJ, Pratt DS, Raikhelson K, Gonzalez-Huezo MS, Heneghan MA, Jeong SH, Ladrón de Guevara AL, Mayo MJ, Dalekos GN, Drenth JPH, Janczewska E, Leggett BA, Nevens F, Vargas V, Zuckerman E, Corpechot C, Fassio E, Hinrichsen H, Invernizzi P, Trivedi PJ, Forman L, Jones DEJ, Ryder SD, Swain MG, Steinberg A, Boudes PF, Choi YJ, McWherter CA; ENHANCE Study Group*. Hirschfield GM, et al. Hepatology. 2023 Aug 1;78(2):397-415. doi: 10.1097/HEP.0000000000000395. Epub 2023 Apr 6. Hepatology. 2023. PMID: 37386786 Free PMC article. Clinical Trial.
BACKGROUND AND AIMS: ENHANCE was a phase 3 study that evaluated efficacy and safety of seladelpar, a selective peroxisome proliferator-activated receptor-delta (PPAR) agonist, versus placebo in patients with primary biliary cholangitis with inadequate response or intolerance to …
BACKGROUND AND AIMS: ENHANCE was a phase 3 study that evaluated efficacy and safety of seladelpar, a selective peroxisome proliferator-activ …
Ursodeoxycholic Acid Treatment-Induced GLOBE Score Changes Are Associated With Liver Transplantation-Free Survival in Patients With Primary Biliary Cholangitis.
de Veer RC, van Hooff MC, Corpechot C, Thorburn D, Invernizzi P, Lammers WJ, Janssen HLA, Battezzati PM, Nevens F, Lindor KD, Floreani A, Ponsioen CY, Mayo MJ, Parés A, Mason AL, Kowdley KV, Trivedi PJ, Hirschfield GM, Goet JC, Bruns T, Dalekos GN, Gatselis NK, Verhelst X, Hansen BE, Harms MH, van der Meer AJ; Global PBC Study Group. de Veer RC, et al. Am J Gastroenterol. 2023 Jul 1;118(7):1196-1203. doi: 10.14309/ajg.0000000000002128. Epub 2022 Dec 14. Am J Gastroenterol. 2023. PMID: 36621963 Free PMC article.
We aimed to assess the association between changes in the GLOBE score (deltaGLOBE) and liver transplantation (LT)-free survival in patients with PBC who were treated with ursodeoxycholic acid (UDCA). METHODS: Among UDCA-treated patients within the Global PBC cohort, …
We aimed to assess the association between changes in the GLOBE score (deltaGLOBE) and liver transplantation (LT)-free survival in patients …
Pegbelfermin selectively reduces secondary bile acid concentrations in patients with non-alcoholic steatohepatitis.
Luo Y, Decato BE, Charles ED, Shevell DE, McNaney C, Shipkova P, Apfel A, Tirucherai GS, Sanyal AJ. Luo Y, et al. JHEP Rep. 2021 Nov 12;4(1):100392. doi: 10.1016/j.jhepr.2021.100392. eCollection 2022 Jan. JHEP Rep. 2021. PMID: 34977519 Free PMC article.
RESULTS: Significant reductions from baseline in serum concentrations of the secondary BA, deoxycholic acid (DCA), and conjugates, were observed with PGBF, but not placebo, in patients with NASH; primary BA concentrations did not significantly change in any arm. ...
RESULTS: Significant reductions from baseline in serum concentrations of the secondary BA, deoxycholic acid (DCA), and conjugates, we …
Liver transplant-free survival according to alkaline phosphatase and GLOBE score in patients with primary biliary cholangitis treated with ursodeoxycholic acid.
de Veer RC, Harms MH, Corpechot C, Thorburn D, Invernizzi P, Janssen HLA, Battezzati PM, Nevens F, Lindor KD, Floreani A, Ponsioen CY, Mayo MJ, Parés A, Mason AL, Kowdley KV, Trivedi PJ, Hirschfield GM, Bruns T, Dalekos GN, Gatselis NK, Verhelst X, Lammers WJ, Hansen BE, van Buuren HR, van der Meer AJ; Global PBC Study Group. de Veer RC, et al. Aliment Pharmacol Ther. 2022 Nov;56(9):1408-1418. doi: 10.1111/apt.17226. Epub 2022 Sep 22. Aliment Pharmacol Ther. 2022. PMID: 36138566 Free PMC article.
BACKGROUND: After 1 year of ursodeoxycholic acid (UDCA), patients with primary biliary cholangitis (PBC) may have a normal GLOBE score despite high alkaline phosphatase (ALP) levels. ...
BACKGROUND: After 1 year of ursodeoxycholic acid (UDCA), patients with primary biliary cholangitis (PBC) may have a normal GLO …
Potent suppression of hydrophobic bile acids by aldafermin, an FGF19 analogue, across metabolic and cholestatic liver diseases.
Sanyal AJ, Ling L, Beuers U, DePaoli AM, Lieu HD, Harrison SA, Hirschfield GM. Sanyal AJ, et al. JHEP Rep. 2021 Feb 19;3(3):100255. doi: 10.1016/j.jhepr.2021.100255. eCollection 2021 Jun. JHEP Rep. 2021. PMID: 33898959 Free PMC article.
BACKGROUND & AIMS: Higher serum bile acid levels are associated with an increased risk of cirrhosis and liver-related morbidity and mortality. ...In particular, bile acids with higher hydrophobicity indices, such as deoxycholic acid, lithocholic acid, gly …
BACKGROUND & AIMS: Higher serum bile acid levels are associated with an increased risk of cirrhosis and liver-related morbidity a …