279 results on '"Nguyen Khac E"'
Search Results
52. O.1.3 Low levels of hepatitis C virus neutralizing antibodies in HIV/HCV coinfected patients
- Author
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Duverlie, G., primary, Castelain, S., additional, Schnuriger, A., additional, François, C., additional, Nguyen-Khac, E., additional, Fournier, C., additional, Schmit, J.L., additional, Capron, D., additional, Dubuisson, J., additional, Wychowski, C., additional, and Thibault, V., additional
- Published
- 2009
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53. Prévalence de l’AgHbs chez les femmes enceintes en Picardie
- Author
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Nguyen-Khac, E., primary, Capron, D., additional, Delmas-Lanta, S., additional, Zielinski, O., additional, Merlin, J., additional, Lerat, A., additional, Gignon, M., additional, Robillart, H., additional, and Braillon, A., additional
- Published
- 2008
- Full Text
- View/download PDF
54. Colorectal carcinoma with potentially resectable metastases: Factors associated with the failure of curative schedule
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Fuks, D., primary, Cook, M.-C., additional, Bréhant, O., additional, Henegar, A., additional, Dumont, F., additional, Chatelain, D., additional, Yzet, T., additional, Mulieri, G., additional, Joly, J.-P., additional, NGuyen-Khac, E., additional, Dupas, J.-L., additional, Mauvais, F., additional, Verhaeghe, P., additional, and Regimbeau, J.-M., additional
- Published
- 2008
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- View/download PDF
55. 38 TREATMENT OF SEVERE ACUTE ALCOHOLIC HEPATITIS (AAH) WITH CORTICOIDS PLUS N-ACETYL CYSTEINE (C-NAC) VERSUS CORTICOIDS (C): PLANED INTERIM ANALYSIS OF A MULTICENTRE, CONTROLLED, RANDOMIZED TRIAL
- Author
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Nguyen-Khac, E., primary, Thevenot, T., additional, Piquet, M.A., additional, Chatelain, D., additional, Tramier, B., additional, Dewael, F., additional, Benferhat, S., additional, Hezam, A., additional, Goria, O., additional, Bernard-Chabert, B., additional, Yzet, T., additional, and Dupas, J.L., additional
- Published
- 2008
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56. 303 ARE REAGENT STRIPS OF VALUE IN THE DIAGNOSIS OF SPONTANEOUS ASCITES INFECTIONS? A CRITICAL REVIEW OF THE LITERATURE
- Author
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Nguyen-Khac, E., primary, Cadranel, J.F., additional, Thevenot, T., additional, and Nousbaum, J.B., additional
- Published
- 2008
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57. [241] PREDICTIVE FACTORS OF SPONTANEOUS BACTERIAL PERITONITIS IN CIRRHOTIC PATIENT S. RESULTS OF A PROSPECTIVE MULTICENTER STUDY
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Nousbaum, J.B., primary, Cadranel, J.F., additional, Bessaguet, C., additional, Nahon, P., additional, Nguyen-Khac, E., additional, Moreau, R., additional, Thevenot, T., additional, Silvain, C., additional, Bureau, C., additional, Nouel, O., additional, Pilette, C., additional, Paupard, T., additional, Pauwels, A., additional, Sapey, T., additional, Grange, I.D., additional, Tran, A., additional, and Club, C., additional
- Published
- 2007
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- View/download PDF
58. [744] ASSESSMENT OF ASYMPTOMATIC LIVER FIBROSIS IN ALCOHOL ABUSER PATIENTS BY TRANSIENT ELASTOGRAPHY (FIBROSCAN)
- Author
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Nguyen-Khac, E., primary, Robert, B., additional, Brevet, M., additional, Tramier, B., additional, Decrombecque, C., additional, Toly, J.P., additional, Grignon, P., additional, Lion, S., additional, Le Page, L., additional, Chatelain, D., additional, and Dupas, J.L., additional
- Published
- 2007
- Full Text
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59. [745] THE -308 TNFα GENE POLYMORPHISM IN SEVERE ACUTE ALCOHOLIC HEPATITIS: IDENTIFICATION OF A NEW SUSCEPTIBILITY MARKER
- Author
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Nguyen-Khac, E., primary, Houchi, H., additional, Daoust, M., additional, Dupas, J.L., additional, and Naassila, M., additional
- Published
- 2007
- Full Text
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60. CO 16-Le syndrome de réponse inflammatoire systémique est un facteur pronostique important chez les malades ayant une cirrhose et une insuffisance rénale
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Thabut, D., primary, Massard, J., additional, Gangloff, A., additional, Carbonell, N., additional, Francoz, C., additional, Nguyen-Khac, E., additional, Duhamel, C., additional, Lebrec, D., additional, Poyanard, T., additional, and Moreau, R., additional
- Published
- 2006
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61. CA 70-Prévalence de la maladie coeliaque au cours de l’hépatite chronique virale C : résultat final d’une étude prospective multicentrique
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Thévenot, T., primary, Denis, J., additional, Jouannaud, V., additional, Renou, C., additional, Crouzet, J., additional, Labadie, H., additional, Abdelli, N., additional, Nguyen-Khac, E., additional, Dumouchel, P., additional, Bresson-Hadni, S., additional, Chousterman, M., additional, and Cadranel, J.F., additional
- Published
- 2006
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62. La naso gastroscopie induit moins de désaturation artérielle en oxygène que la fibroscopie oeso-gastro-duodénale par voie buccale sans sédation
- Author
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Nguyen-Khac, E, primary, Gournay, N, additional, Thevenot, T, additional, Masset, D, additional, Lurka, L, additional, Quinville, E, additional, Carlier, B, additional, and Capron, D, additional
- Published
- 2004
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63. La Revue de Médecine Interne
- Author
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Thévenot, T., primary, Nguyen-Khac, E., additional, Tilmant, L., additional, Tiry, C., additional, Welty, S., additional, Toutouch, M., additional, Merzoug, N., additional, Janicki, E., additional, and Cadranel, J.F., additional
- Published
- 2003
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64. Hyperthyroïdie et hypertension artérielle pulmonaire
- Author
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Thévenot, T., primary, Nourry, A., additional, Risbourg, M.A., additional, Nguyen-Khac, E., additional, Vancauwenberge, J.M., additional, Philias, A., additional, and Vallet, P.M., additional
- Published
- 2002
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65. Thrombopénie auto-immune, infection à cytomégalovirus et hémorragie digestive
- Author
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Thévenot, T., primary, Caulier, M.T., additional, Nguyen-Khac, E., additional, Tiry, C., additional, Welty, S., additional, and Leroy, M.H., additional
- Published
- 2002
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- View/download PDF
66. Maladie de Parkinson et achalasie
- Author
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Thévenot, T., primary, Cattan, S., additional, Nguyen-Khac, E., additional, Quinton, J.F., additional, Tiry, C., additional, Welty, S., additional, and Leroy, M.H., additional
- Published
- 2002
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67. Pancréatite aiguë et rétinopathie de Purtscher
- Author
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Thevenot, T, primary, Guidez, H, additional, Nguyen-Khac, E, additional, Aissani, F, additional, Benziane, A, additional, and Levy, P, additional
- Published
- 2002
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68. Fièvre à Hantavirus et leptospirose révélés par des symptômes digestifs
- Author
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Thévenot, T., primary, Tiry, C., additional, Nguyen-Khac, E., additional, Degremont, G., additional, Benziane, K., additional, Vallet, P.M., additional, Malherbe, P., additional, and Leroy, M.H., additional
- Published
- 2002
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69. Pancréatite aiguë et rétinopathie de Purtscher
- Author
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Thévenot, T., primary, Aissani, F., additional, Guidez, H., additional, Sharshar, S., additional, Nguyen-Khac, E., additional, El Makhloufi, A., additional, Benziane, K., additional, and Levy, P., additional
- Published
- 2001
- Full Text
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70. Maladie cœliaque et hépatite auto-immune: une association rare et un pronostic lié à la précocité du diagnostic de l'hépatite auto-immune
- Author
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Thévenot, T., primary, Canva-Delcambre, V., additional, Nguyen-Khac, E., additional, Le Baron, F., additional, Cortot, A., additional, Colombel, J.F., additional, and Paris, J.C., additional
- Published
- 1999
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71. Antibiotic prophylaxis for bacterial infections in cirrhotic patients with ascites
- Author
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Bernard, B, primary, Grang��, JD, additional, Nguyen, Khac E, additional, Regimbeau, C, additional, Amiot, X, additional, Opolon, P, additional, and Poynard, T, additional
- Published
- 1999
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72. Glucocorticoids plus N-acetylcysteine in severe alcoholic hepatitis.
- Author
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Nguyen-Khac E, Thevenot T, Piquet MA, Benferhat S, Goria O, Chatelain D, Tramier B, Dewaele F, Ghrib S, Rudler M, Carbonell N, Tossou H, Bental A, Bernard-Chabert B, Dupas JL, and AAH-NAC Study Group
- Published
- 2011
73. Lack of association between tumour necrosis factor receptor types 1 and 2 gene polymorphism and severe acute alcoholic hepatitis.
- Author
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Nguyen-Khac E, Houchi H, Daoust M, Dupas JL, and Naassila M
- Published
- 2010
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- View/download PDF
74. The -308 TNFalpha gene polymorphism in severe acute alcoholic hepatitis: identification of a new susceptibility marker.
- Author
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Nguyen-Khac E, Houchi H, Daoust M, Dupas JL, and Naassila M
- Abstract
BACKGROUND: This study investigated whether genetic polymorphisms in the tumor necrosis factor alpha (TNFalpha) gene's promoter region play a role in severe acute alcoholic hepatitis (AAH). METHODS: One-hundred and fifty patients (58 AAH patients, 45 cirrhosis group free-AAH, 47 healthy group) were genotyped for 3 TNFalpha polymorphisms (-238, -308, -863) using a polymerase chain reaction-restriction fragment length polymorphism technique. Serum TNFalpha levels were determined. RESULTS: The TNFalpha-308 allele A frequency was significantly lower in AAH group (0.09), than cirrhosis (0.28) (p < 0.001), and healthy groups (p < 0.001). The TNFalpha-308 A/G, A/A genotypes were significantly lower in AAH group, than cirrhosis (p = 0.005), and healthy groups (p < 0.001). For AAH group, there were no clinical, biological, and serum TNFalpha differences between the -308 G/G and A/G, A/A genotype patients, apart higher transaminase in the former group (p = 0.02). AAH and cirrhosis groups did not differ for the frequency of TNFalpha-238, -863 polymorphisms. The specific genotype did not appear to have any influence on the therapeutic response following corticotherapy or posttreatment 6-month survival. In the AAH group, nonsurvivors had higher TNFalpha levels than survivors (7.9 +/- 8.8 vs. 3.3 +/- 1.6 pg/ml, p = 0.01). CONCLUSIONS: These results attest to the involvement of TNFalpha-related genetic factors in susceptibility to AAH. [ABSTRACT FROM AUTHOR]
- Published
- 2008
- Full Text
- View/download PDF
75. Résultats et place du Fibroscan® dans le diagnostic non invasif de la fibrose hépatique
- Author
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Nguyen-Khac, E.
- Subjects
- *
LIVER diseases , *FIBROSIS , *NONINVASIVE diagnostic tests , *HEPATITIS C , *COLLAGEN diseases - Abstract
Abstract: Background and aims: Diagnosis of liver fibrosis by transient elastography (Fibroscan®) is a new and non-invasive method. We report its results, and compare them with the non-invasive biological tests. Results: Fibroscan® is validated for chronic hepatitis C, allowing to diagnose the fibrosis (Métavir) F2, F3 and F4 with areas under the ROC curve of 0.79–0.83, 0.90–0.91 and 0.91–0.97 respectively. The non-invasive diagnosis of the cirrhosis can be made with positive and negative predictive values from 70 to 95% and 77 in 95%. Preliminary data concern the HCV–HIV co-infections, primary biliary cirrhosis, NASH, portal hypertension, and the follow-up of the hepatic fibrosis. These results are altogether comparable to the various non-invasive biological tests, for cirrhosis diagnosis. Conclusions: It''s remain to determine the respective places of Fibroscan® and non-invasive biological tests, in the liver fibrosis diagnosis. [Copyright &y& Elsevier]
- Published
- 2007
- Full Text
- View/download PDF
76. Noninvasive diagnosis of liver fibrosis by ultrasonic transient elastography (Fibroscan).
- Author
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Nguyen-Khac E, Capron D, Nguyen-Khac, Eric, and Capron, Dominique
- Published
- 2006
- Full Text
- View/download PDF
77. Diagnosis of spontaneous bacterial peritonitis in cirrhotic patients by use of two reagent strips.
- Author
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Thévenot T, Cadranel J, Nguyen-Khac E, Tilmant L, Tiry C, Welty S, Merzoug N, Thévenot, Thierry, Cadranel, Jean-François, Nguyen-Khac, Eric, Tilmant, Laetitia, Tiry, Catherine, Welty, Stéphane, and Merzoug, Noureddine
- Published
- 2004
78. [Celiac disease and liver involvement]
- Author
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Thierry Thevenot, Mathurin P, Di Martino V, Nguyen-Khac E, Canva-Delcambre V, Campin G, Cortot A, Jf, Colombel, and Jc, Paris
79. PII: S0248-8663(03)80034-6
- Author
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Thévenot, T., Nguyen-Khac, E., Tilmant, L., Tiry, C., Welty, S., Toutouch, M., Merzoug, N., Janicki, E., and Cadranel, J.F.
- Published
- 2003
- Full Text
- View/download PDF
80. Maladie de Parkinson et dysphagie
- Author
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Thevenot, T, Cattan, S, Nguyen-Khac, E, Ucla, E, Welty, S, and Bailleul, O
- Published
- 2003
- Full Text
- View/download PDF
81. CommunicationDétection de l'infection du liquide d'ascite par la bandelette urinaire Multistix 8SG
- Author
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Thévenot, T., Nguyen-Khac, E., Tilmant, L., Tiry, C., Welty, S., Toutouch, M., Merzoug, N., Janicki, E., and Cadranel, J.F.
- Published
- 2003
- Full Text
- View/download PDF
82. Pancre´atite aigue¨ et re´tinopathie de Purtscher
- Author
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The´venot, T., Aissani, F., Guidez, H., Sharshar, S., Nguyen-Khac, E., Makhloufi, A. El, Benziane, K., and Levy, P.
- Published
- 2001
- Full Text
- View/download PDF
83. Obeticholic acid for the treatment of non-alcoholic steatohepatitis: interim analysis from a multicentre, randomised, placebo-controlled phase 3 trial
- Author
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Zobair M Younossi, Vlad Ratziu, Rohit Loomba, Mary Rinella, Quentin M Anstee, Zachary Goodman, Pierre Bedossa, Andreas Geier, Susanne Beckebaum, Philip N Newsome, David Sheridan, Muhammad Y Sheikh, James Trotter, Whitfield Knapple, Eric Lawitz, Manal F Abdelmalek, Kris V Kowdley, Aldo J Montano-Loza, Jerome Boursier, Philippe Mathurin, Elisabetta Bugianesi, Giuseppe Mazzella, Antonio Olveira, Helena Cortez-Pinto, Isabel Graupera, David Orr, Lise Lotte Gluud, Jean-Francois Dufour, David Shapiro, Jason Campagna, Luna Zaru, Leigh MacConell, Reshma Shringarpure, Stephen Harrison, Arun J Sanyal, Manal Abdelmalek, Gary Abrams, Humberto Aguilar, Aijaz Ahmed, Elmar Aigner, Guruprasad Aithal, Aftab Ala, William Alazawi, Agustin Albillos, Michael Allison, Sfa Al-Shamma, Raul Andrade, Pietro Andreone, Mario Angelico, Victor Ankoma-Sey, Quentin Anstee, Rodolphe Anty, Victor Araya, Juan Ignacio Arenas Ruiz, Perttu Arkkila, Marty Arora, Tarik Asselah, Jennifer Au, Oyekoya Ayonrinde, Robert James Bailey, Maya Balakrishnan, Kiran Bambha, Meena Bansal, Sidney Barritt, John Bate, Jorge Beato, Jaideep Behari, Pablo Bellot, Ziv Ben Ari, Michael Bennett, Marina Berenguer, Benedetta Terziroli Beretta-Piccoli, Thomas Berg, Maurizio Bonacini, Lucia Bonet, Brian Borg, Marc Bourliere, William Bowman, David Bradley, Marija Brankovic, Marius Braun, Jean-Pierre Bronowicki, Savino Bruno, Cindy Cai, Amy Calderon, José Luis Calleja Panero, Elizabeth Carey, Michal Carmiel, Jose Antonio Carrión, Matthew Cave, Cristina Chagas, Tawfik Chami, Alan Chang, Allan Coates, Jeremy Cobbold, Charlote Costentin, Kathleen Corey, Lynsey Corless, Javier Crespo, Oscar Cruz Pereira, Victor de Ledinghen, Andrew deLemos, Moises Diago, Mamie Dong, Jean-François Dufour, Predrag Dugalic, Winston Dunn, Magby Elkhashab, Michael Epstein, Maria Desamparados Escudero-Garcia, Ohad Etzion, Larry Evans, Robert Falcone, Conrado Fernandez, Jose Ferreira, Scott Fink, Kevin Finnegan, Roberto Firpi-Morell, Annarosa Floreani, Thierry Fontanges, Ryan Ford, Ewan Forrest, Andrew Fowell, Anna Ludovica Fracanzani, Sven Francque, Bradley Freilich, Juan Frias, Michael Fuchs, Javier Fuentes, Michael Galambos, Juan Gallegos, Anja Geerts, Jacob George, Maged Ghali, Reem Ghalib, Pierre Gholam, Pere Gines, Norman Gitlin, Tobias Goeser, John Goff, Stuart Gordon, Frederic Gordon, Odile Goria, Shaun Greer, Alla Grigorian, Henning Gronbaek, Maeva Guillaume, Naresh Gunaratnam, Dina Halegoua-De Marzio, Bilal Hameed, Stephanie Hametner, James Hamilton, Marek Hartleb, Tarek Hassanein, Dieter Häussinger, Paul Hellstern, Robert Herring, Eva Heurich, Christophe Hezode, Holger Hinrichsen, Peter Holland Fischer, Yves Horsmans, Jonathan Huang, Hyder Hussaini, Antoine Jakiche, Lennox Jeffers, Blake Jones, Rosa Jorge, Francisco Jorquera, Shoba Joshi, Alisan Kahraman, Kelly Kaita, Nicholas Karyotakis, Zeid Kayali, Stergios Kechagias, Thomas Kepczyk, Mandana Khalili, Hicham Khallafi, Johannes Kluwe, Anita Kohli, Kevin Korenblat, Kris Kowdley, Aleksander Krag, Richard Krause, Andreas Kremer, Karen Krok, Miodrag Krstic, Marcelo Kugelmas, Sonal Kumar, Scott Kuwada, Damien Labarriere, Michelle Lai, Wim Laleman, Pietro Lampertico, Alice Lee, Vincent Leroy, Steven Lidofsky, Tina Huey Lim, Joseph Lim, Donald Lipkis, Ester Little, Amadeo Lonardo, Michelle Long, Velimir Anthony Christopher Luketic, Yoav Lurie, Guilherme Macedo, Joana Magalhaes, Mihály Makara, Benedict Maliakkal, Michael Manns, Pinelopi Manousou, Parvez Mantry, Giulio Marchesini, Carla Marinho, Paul Marotta, Hanns-Ulrich Marschall, Linda Martinez, Marlyn Mayo, Mark McCullen, William McLaughlin, Uta Merle, Raphael Merriman, Apurva Modi, Esther Molina, Aldo Montano-Loza, Carlos Monteverde, Amilcar Morales Cardona, Sulleman Moreea, Christophe Moreno, Filomena Morisco, Abdullah Mubarak, Beat Muellhaupt, Sandeep Mukherjee, Tobias Müller, Aleksandar Nagorni, Jahnavi Naik, Guy Neff, Moises Nevah, Philip Newsome, Eric Nguyen-Khac, Mazen Noureddin, Jude Oben, Hans Orlent, James Orr, Grisell Ortiz-Lasanta, Violaine Ozenne, Prashant Pandya, Angelo Paredes, James Park, Joykumar Patel, Keyur Patel, Sonali Paul, Heather Patton, Markus Peck-Radosavljevic, Salvatore Petta, Stephen Pianko, Anna Piekarska, Neville Pimstone, Joseph Pisegna, Paul Pockros, Stanislas Pol, Michael Porayko, John Poulos, David Pound, Joe Pouzar, Jose Presa Ramos, Nikolaos Pyrsopoulos, Nila Rafiq, Kate Muller, Alnoor Ramji, Ravi Ravinuthala, Chakradhar Reddy, Gautham Reddy K G, K. Rajender Reddy K R, Frederic Regenstein, Robert Reindollar, Justin Reynolds, Andres Riera, Jose Rivera Acosta, Geert Robaeys, Stuart Roberts, Federico Rodriguez-Perez, Sandor Romero, Manuel Romero-Gomez, Raymond Rubin, Mariagrazia Rumi, Simon Rushbrook, Christian Rust, Michael Ryan, Rifaat Safadi, Adnan Said, Kimmo Salminen, Didier Samuel, John Santoro, Arun Sanyal, Souvik Sarkar, Cynthia Schaeffer, Jörn Schattenberg, Ingolf Schiefke, Eugene Schiff, Wolfgang Schmidt, Jeffrey Schneider, Jeoffrey Schouten, Michael Schultz, Giada Sebastiani, David Semela, Thomas Sepe, Aasim Sheikh, Muhammad Sheikh, Kenneth Sherman, Oren Shibolet, Mitchell Shiffman, Asma Siddique, Cyril Sieberhagen, Samuel Sigal, Katarzyna Sikorska, Krzysztof Simon, Marie Sinclair, Richard Skoien, Joel Solis, Siddharth Sood, Bob Souder, James Spivey, Per Stal, Laura Stinton, Simone Strasser, Petar Svorcan, Gyongzi Szabo, Andrew Talal, Edward Tam, Brent Tetri, Paul Thuluvath, Hillel Tobias, Krzysztof Tomasiewicz, Dawn Torres, Albert Tran, Michael Trauner, Christian Trautwein, Emanuel Tsochatzis, Esther Unitt, Victor Vargas, Istvan Varkonyi, Ella Veitsman, Umberto Vespasiani Gentilucci, David Victor, John Vierling, Catherine Vincent, Aron Vincze, Manfred von der Ohe, Natasha Von Roenn, Raj Vuppalanchi, Michael Waters, Kymberly Watt, Julia Wattacheril, Martin Weltman, Amanda Wieland, Gregory Wiener, Alonzo Williams A, Jeffrey Williams J, Jason Wilson, Maria Yataco, Eric Yoshida, Ziad Younes, Liyun Yuan, Adam Zivony, Donald Zogg, Heinz Zoller, Fabien Zoulim, Eli Zuckerman, Massimo Zuin, Younossi Z.M., Ratziu V., Loomba R., Rinella M., Anstee Q.M., Goodman Z., Bedossa P., Geier A., Beckebaum S., Newsome P.N., Sheridan D., Sheikh M.Y., Trotter J., Knapple W., Lawitz E., Abdelmalek M.F., Kowdley K.V., Montano-Loza A.J., Boursier J., Mathurin P., Bugianesi E., Mazzella G., Olveira A., Cortez-Pinto H., Graupera I., Orr D., Gluud L.L., Dufour J.-F., Shapiro D., Campagna J., Zaru L., MacConell L., Shringarpure R., Harrison S., Sanyal A.J., Abdelmalek M., Abrams G., Aguilar H., Ahmed A., Aigner E., Aithal G., Ala A., Alazawi W., Albillos A., Allison M., Al-Shamma S., Andrade R., Andreone P., Angelico M., Ankoma-Sey V., Anstee Q., Anty R., Araya V., Arenas Ruiz J.I., Arkkila P., Arora M., Asselah T., Au J., Ayonrinde O., Bailey R.J., Balakrishnan M., Bambha K., Bansal M., Barritt S., Bate J., Beato J., Behari J., Bellot P., Ben Ari Z., Bennett M., Berenguer M., Beretta-Piccoli B.T., Berg T., Bonacini M., Bonet L., Borg B., Bourliere M., Bowman W., Bradley D., Brankovic M., Braun M., Bronowicki J.-P., Bruno S., Cai C., Calleja Panero J.L., Carey E., Carmiel M., Carrion J.A., Cave M., Chagas C., Chami T., Chang A., Coates A., Cobbold J., Corey K., Corless L., Crespo J., Cruz Pereira O., de Ledinghen V., deLemos A., Diago M., Dugalic P., Dunn W., Elkhashab M., Epstein M., Escudero-Garcia M.D., Etzion O., Evans L., Falcone R., Fernandez C., Ferreira J., Fink S., Finnegan K., Firpi-Morell R., Floreani A., Fontanges T., Ford R., Forrest E., Fowell A., Fracanzani A.L., Francque S., Freilich B., Frias J., Fuchs M., Fuentes J., Galambos M., Gallegos J., Geerts A., George J., Ghali M., Ghalib R., Gholam P., Gines P., Gitlin N., Goeser T., Goff J., Gordon S., Gordon F., Goria O., Greer S., Grigorian A., Gronbaek H., Guillaume M., Gunaratnam N., Halegoua-De Marzio D., Hameed B., Hametner S., Hamilton J., Hartleb M., Hassanein T., Haussinger D., Hellstern P., Herring R., Heurich E., Hezode C., Hinrichsen H., Holland Fischer P., Horsmans Y., Huang J., Jakiche A., Jeffers L., Jones B., Jorge R., Jorquera F., Kahraman A., Kaita K., Karyotakis N., Kayali Z., Kechagias S., Kepczyk T., Khalili M., Khallafi H., Kluwe J., Kohli A., Korenblat K., Kowdley K., Krag A., Krause R., Kremer A., Krok K., Krstic M., Kugelmas M., Kumar S., Labarriere D., Lai M., Lampertico P., Lee A., Leroy V., Lidofsky S., Lim T.H., Lim J., Lipkis D., Little E., Lonardo A., Long M., Lurie Y., Macedo G., Makara M., Maliakkal B., Manns M., Manousou P., Mantry P., Marchesini G., Marinho C., Marotta P., Marschall H.-U., Mayo M., McCullen M., McLaughlin W., Merriman R., Modi A., Molina E., Montano-Loza A., Monteverde C., Moreea S., Moreno C., Morisco F., Mubarak A., Muellhaupt B., Mukherjee S., Muller T., Nagorni A., Naik J., Neff G., Nevah M., Newsome P., Nguyen-Khac E., Noureddin M., Oben J., Orlent H., Orr J., Ortiz-Lasanta G., Ozenne V., Pandya P., Paredes A., Park J., Patel J., Patel K., Uta M., Patton H., Peck-Radosavljevic M., Petta S., Pianko S., Piekarska A., Pimstone N., Pockros P., Pol S., Porayko M., Poulos J., Pound D., Pouzar J., Presa Ramos J., Pyrsopoulos N., Rafiq N., Muller K., Ramji A., Ravinuthala R., Reddy C., Reddy K G G., Reddy K R K.R., Regenstein F., Reindollar R., Riera A., Rivera Acosta J., Robaeys G., Roberts S., Rodriguez-Perez F., Romero-Gomez M., Rubin R., Rumi M., Rushbrook S., Rust C., Ryan M., Safadi R., Said A., Salminen K., Samuel D., Santoro J., Sanyal A., Sarkar S., Schaeffer C., Schattenberg J., Schiefke I., Schiff E., Schmidt W., Schneider J., Schouten J., Schultz M., Sebastiani G., Semela D., Sepe T., Sheikh A., Sheikh M., Sherman K., Shibolet O., Shiffman M., Siddique A., Sieberhagen C., Sigal S., Sikorska K., Simon K., Sinclair M., Skoien R., Solis J., Sood S., Souder B., Spivey J., Stal P., Stinton L., Strasser S., Svorcan P., Szabo G., Talal A., Tam E., Tetri B., Thuluvath P., Tobias H., Tomasiewicz K., Torres D., Trauner M., Trautwein C., Tsochatzis E., Unitt E., Vargas V., Varkonyi I., Veitsman E., Vespasiani Gentilucci U., Victor D., Vierling J., Vincent C., Vincze A., von der Ohe M., Von Roenn N., Vuppalanchi R., Waters M., Watt K., Weltman M., Wieland A., Wiener G., Williams A A., Williams J J., Wilson J., Yataco M., Yoshida E., Younes Z., Yuan L., Zivony A., Zogg D., Zoller H., Zoulim F., Zuckerman E., Zuin M., Repositório da Universidade de Lisboa, Younossi, Z. M., Ratziu, V., Loomba, R., Rinella, M., Anstee, Q. M., Goodman, Z., Bedossa, P., Geier, A., Beckebaum, S., Newsome, P. N., Sheridan, D., Sheikh, M. Y., Trotter, J., Knapple, W., Lawitz, E., Abdelmalek, M. F., Kowdley, K. V., Montano-Loza, A. J., Boursier, J., Mathurin, P., Bugianesi, E., Mazzella, G., Olveira, A., Cortez-Pinto, H., Graupera, I., Orr, D., Gluud, L. L., Dufour, J. -F., Shapiro, D., Campagna, J., Zaru, L., Macconell, L., Shringarpure, R., Harrison, S., Sanyal, A. J., Abdelmalek, M., Abrams, G., Aguilar, H., Ahmed, A., Aigner, E., Aithal, G., Ala, A., Alazawi, W., Albillos, A., Allison, M., Al-Shamma, S., Andrade, R., Andreone, P., Angelico, M., Ankoma-Sey, V., Anstee, Q., Anty, R., Araya, V., Arenas Ruiz, J. I., Arkkila, P., Arora, M., Asselah, T., Au, J., Ayonrinde, O., Bailey, R. J., Balakrishnan, M., Bambha, K., Bansal, M., Barritt, S., Bate, J., Beato, J., Behari, J., Bellot, P., Ben Ari, Z., Bennett, M., Berenguer, M., Beretta-Piccoli, B. T., Berg, T., Bonacini, M., Bonet, L., Borg, B., Bourliere, M., Bowman, W., Bradley, D., Brankovic, M., Braun, M., Bronowicki, J. -P., Bruno, S., Cai, C., Calleja Panero, J. L., Carey, E., Carmiel, M., Carrion, J. A., Cave, M., Chagas, C., Chami, T., Chang, A., Coates, A., Cobbold, J., Corey, K., Corless, L., Crespo, J., Cruz Pereira, O., de Ledinghen, V., Delemos, A., Diago, M., Dugalic, P., Dunn, W., Elkhashab, M., Epstein, M., Escudero-Garcia, M. D., Etzion, O., Evans, L., Falcone, R., Fernandez, C., Ferreira, J., Fink, S., Finnegan, K., Firpi-Morell, R., Floreani, A., Fontanges, T., Ford, R., Forrest, E., Fowell, A., Fracanzani, A. L., Francque, S., Freilich, B., Frias, J., Fuchs, M., Fuentes, J., Galambos, M., Gallegos, J., Geerts, A., George, J., Ghali, M., Ghalib, R., Gholam, P., Gines, P., Gitlin, N., Goeser, T., Goff, J., Gordon, S., Gordon, F., Goria, O., Greer, S., Grigorian, A., Gronbaek, H., Guillaume, M., Gunaratnam, N., Halegoua-De Marzio, D., Hameed, B., Hametner, S., Hamilton, J., Hartleb, M., Hassanein, T., Haussinger, D., Hellstern, P., Herring, R., Heurich, E., Hezode, C., Hinrichsen, H., Holland Fischer, P., Horsmans, Y., Huang, J., Jakiche, A., Jeffers, L., Jones, B., Jorge, R., Jorquera, F., Kahraman, A., Kaita, K., Karyotakis, N., Kayali, Z., Kechagias, S., Kepczyk, T., Khalili, M., Khallafi, H., Kluwe, J., Kohli, A., Korenblat, K., Kowdley, K., Krag, A., Krause, R., Kremer, A., Krok, K., Krstic, M., Kugelmas, M., Kumar, S., Labarriere, D., Lai, M., Lampertico, P., Lee, A., Leroy, V., Lidofsky, S., Lim, T. H., Lim, J., Lipkis, D., Little, E., Lonardo, A., Long, M., Lurie, Y., Macedo, G., Makara, M., Maliakkal, B., Manns, M., Manousou, P., Mantry, P., Marchesini, G., Marinho, C., Marotta, P., Marschall, H. -U., Mayo, M., Mccullen, M., Mclaughlin, W., Merriman, R., Modi, A., Molina, E., Montano-Loza, A., Monteverde, C., Moreea, S., Moreno, C., Morisco, F., Mubarak, A., Muellhaupt, B., Mukherjee, S., Muller, T., Nagorni, A., Naik, J., Neff, G., Nevah, M., Newsome, P., Nguyen-Khac, E., Noureddin, M., Oben, J., Orlent, H., Orr, J., Ortiz-Lasanta, G., Ozenne, V., Pandya, P., Paredes, A., Park, J., Patel, J., Patel, K., Uta, M., Patton, H., Peck-Radosavljevic, M., Petta, S., Pianko, S., Piekarska, A., Pimstone, N., Pockros, P., Pol, S., Porayko, M., Poulos, J., Pound, D., Pouzar, J., Presa Ramos, J., Pyrsopoulos, N., Rafiq, N., Muller, K., Ramji, A., Ravinuthala, R., Reddy, C., Reddy K G, G., Reddy K R, K. R., Regenstein, F., Reindollar, R., Riera, A., Rivera Acosta, J., Robaeys, G., Roberts, S., Rodriguez-Perez, F., Romero-Gomez, M., Rubin, R., Rumi, M., Rushbrook, S., Rust, C., Ryan, M., Safadi, R., Said, A., Salminen, K., Samuel, D., Santoro, J., Sanyal, A., Sarkar, S., Schaeffer, C., Schattenberg, J., Schiefke, I., Schiff, E., Schmidt, W., Schneider, J., Schouten, J., Schultz, M., Sebastiani, G., Semela, D., Sepe, T., Sheikh, A., Sheikh, M., Sherman, K., Shibolet, O., Shiffman, M., Siddique, A., Sieberhagen, C., Sigal, S., Sikorska, K., Simon, K., Sinclair, M., Skoien, R., Solis, J., Sood, S., Souder, B., Spivey, J., Stal, P., Stinton, L., Strasser, S., Svorcan, P., Szabo, G., Talal, A., Tam, E., Tetri, B., Thuluvath, P., Tobias, H., Tomasiewicz, K., Torres, D., Trauner, M., Trautwein, C., Tsochatzis, E., Unitt, E., Vargas, V., Varkonyi, I., Veitsman, E., Vespasiani Gentilucci, U., Victor, D., Vierling, J., Vincent, C., Vincze, A., von der Ohe, M., Von Roenn, N., Vuppalanchi, R., Waters, M., Watt, K., Weltman, M., Wieland, A., Wiener, G., Williams A, A., Williams J, J., Wilson, J., Yataco, M., Yoshida, E., Younes, Z., Yuan, L., Zivony, A., Zogg, D., Zoller, H., Zoulim, F., Zuckerman, E., Zuin, M., Younossi, Zobair M, Ratziu, Vlad, Loomba, Rohit, Rinella, Mary, Anstee, Quentin M, Goodman, Zachary, Bedossa, Pierre, Geier, Andrea, Beckebaum, Susanne, Newsome, Philip N, Sheridan, David, Sheikh, Muhammad Y, Trotter, Jame, Knapple, Whitfield, Lawitz, Eric, Abdelmalek, Manal F, Kowdley, Kris V, Montano-Loza, Aldo J, Boursier, Jerome, Mathurin, Philippe, Bugianesi, Elisabetta, Mazzella, Giuseppe, Olveira, Antonio, Cortez-Pinto, Helena, Graupera, Isabel, Orr, David, Gluud, Lise Lotte, Dufour, Jean-Francoi, Shapiro, David, Campagna, Jason, Zaru, Luna, MacConell, Leigh, Shringarpure, Reshma, Harrison, Stephen, Sanyal, Arun J, Abdelmalek, Manal, Abrams, Gary, Aguilar, Humberto, Ahmed, Aijaz, Aigner, Elmar, Aithal, Guruprasad, Ala, Aftab, Alazawi, William, Albillos, Agustin, Allison, Michael, Al-Shamma, Sfa, Andrade, Raul, Andreone, Pietro, Angelico, Mario, Ankoma-Sey, Victor, Anstee, Quentin, Anty, Rodolphe, Araya, Victor, Arenas Ruiz, Juan Ignacio, Arkkila, Perttu, Arora, Marty, Asselah, Tarik, Au, Jennifer, Ayonrinde, Oyekoya, Bailey, Robert Jame, Balakrishnan, Maya, Bambha, Kiran, Bansal, Meena, Barritt, Sidney, Bate, John, Beato, Jorge, Behari, Jaideep, Bellot, Pablo, Ben Ari, Ziv, Bennett, Michael, Berenguer, Marina, Beretta-Piccoli, Benedetta Terziroli, Berg, Thoma, Bonacini, Maurizio, Bonet, Lucia, Borg, Brian, Bourliere, Marc, Bowman, William, Bradley, David, Brankovic, Marija, Braun, Mariu, Bronowicki, Jean-Pierre, Bruno, Savino, Cai, Cindy, Calleja Panero, José Lui, Carey, Elizabeth, Carmiel, Michal, Carrión, Jose Antonio, Cave, Matthew, Chagas, Cristina, Chami, Tawfik, Chang, Alan, Coates, Allan, Cobbold, Jeremy, Corey, Kathleen, Corless, Lynsey, Crespo, Javier, Cruz Pereira, Oscar, de Ledinghen, Victor, deLemos, Andrew, Diago, Moise, Dufour, Jean-Françoi, Dugalic, Predrag, Dunn, Winston, Elkhashab, Magby, Epstein, Michael, Escudero-Garcia, Maria Desamparado, Etzion, Ohad, Evans, Larry, Falcone, Robert, Fernandez, Conrado, Ferreira, Jose, Fink, Scott, Finnegan, Kevin, Firpi-Morell, Roberto, Floreani, Annarosa, Fontanges, Thierry, Ford, Ryan, Forrest, Ewan, Fowell, Andrew, Fracanzani, Anna Ludovica, Francque, Sven, Freilich, Bradley, Frias, Juan, Fuchs, Michael, Fuentes, Javier, Galambos, Michael, Gallegos, Juan, Geerts, Anja, George, Jacob, Ghali, Maged, Ghalib, Reem, Gholam, Pierre, Gines, Pere, Gitlin, Norman, Goeser, Tobia, Goff, John, Gordon, Stuart, Gordon, Frederic, Goria, Odile, Greer, Shaun, Grigorian, Alla, Gronbaek, Henning, Guillaume, Maeva, Gunaratnam, Naresh, Halegoua-De Marzio, Dina, Hameed, Bilal, Hametner, Stephanie, Hamilton, Jame, Hartleb, Marek, Hassanein, Tarek, Häussinger, Dieter, Hellstern, Paul, Herring, Robert, Heurich, Eva, Hezode, Christophe, Hinrichsen, Holger, Holland Fischer, Peter, Horsmans, Yve, Huang, Jonathan, Jakiche, Antoine, Jeffers, Lennox, Jones, Blake, Jorge, Rosa, Jorquera, Francisco, Kahraman, Alisan, Kaita, Kelly, Karyotakis, Nichola, Kayali, Zeid, Kechagias, Stergio, Kepczyk, Thoma, Khalili, Mandana, Khallafi, Hicham, Kluwe, Johanne, Kohli, Anita, Korenblat, Kevin, Kowdley, Kri, Krag, Aleksander, Krause, Richard, Kremer, Andrea, Krok, Karen, Krstic, Miodrag, Kugelmas, Marcelo, Kumar, Sonal, Labarriere, Damien, Lai, Michelle, Lampertico, Pietro, Lee, Alice, Leroy, Vincent, Lidofsky, Steven, Lim, Tina Huey, Lim, Joseph, Lipkis, Donald, Little, Ester, Lonardo, Amadeo, Long, Michelle, Lurie, Yoav, Macedo, Guilherme, Makara, Mihály, Maliakkal, Benedict, Manns, Michael, Manousou, Pinelopi, Mantry, Parvez, Marchesini, Giulio, Marinho, Carla, Marotta, Paul, Marschall, Hanns-Ulrich, Mayo, Marlyn, McCullen, Mark, McLaughlin, William, Merriman, Raphael, Modi, Apurva, Molina, Esther, Montano-Loza, Aldo, Monteverde, Carlo, Moreea, Sulleman, Moreno, Christophe, Morisco, Filomena, Mubarak, Abdullah, Muellhaupt, Beat, Mukherjee, Sandeep, Müller, Tobia, Nagorni, Aleksandar, Naik, Jahnavi, Neff, Guy, Nevah, Moise, Newsome, Philip, Nguyen-Khac, Eric, Noureddin, Mazen, Oben, Jude, Orlent, Han, Orr, Jame, Ortiz-Lasanta, Grisell, Ozenne, Violaine, Pandya, Prashant, Paredes, Angelo, Park, Jame, Patel, Joykumar, Patel, Keyur, Uta, Merle, Patton, Heather, Peck-Radosavljevic, Marku, Petta, Salvatore, Pianko, Stephen, Piekarska, Anna, Pimstone, Neville, Pockros, Paul, Pol, Stanisla, Porayko, Michael, Poulos, John, Pound, David, Pouzar, Joe, Presa Ramos, Jose, Pyrsopoulos, Nikolao, Rafiq, Nila, Muller, Kate, Ramji, Alnoor, Ravinuthala, Ravi, Reddy, Chakradhar, Reddy K G, Gautham, Reddy K R, K. Rajender, Regenstein, Frederic, Reindollar, Robert, Riera, Andre, Rivera Acosta, Jose, Robaeys, Geert, Roberts, Stuart, Rodriguez-Perez, Federico, Romero-Gomez, Manuel, Rubin, Raymond, Rumi, Mariagrazia, Rushbrook, Simon, Rust, Christian, Ryan, Michael, Safadi, Rifaat, Said, Adnan, Salminen, Kimmo, Samuel, Didier, Santoro, John, Sanyal, Arun, Sarkar, Souvik, Schaeffer, Cynthia, Schattenberg, Jörn, Schiefke, Ingolf, Schiff, Eugene, Schmidt, Wolfgang, Schneider, Jeffrey, Schouten, Jeoffrey, Schultz, Michael, Sebastiani, Giada, Semela, David, Sepe, Thoma, Sheikh, Aasim, Sheikh, Muhammad, Sherman, Kenneth, Shibolet, Oren, Shiffman, Mitchell, Siddique, Asma, Sieberhagen, Cyril, Sigal, Samuel, Sikorska, Katarzyna, Simon, Krzysztof, Sinclair, Marie, Skoien, Richard, Solis, Joel, Sood, Siddharth, Souder, Bob, Spivey, Jame, Stal, Per, Stinton, Laura, Strasser, Simone, Svorcan, Petar, Szabo, Gyongzi, Talal, Andrew, Tam, Edward, Tetri, Brent, Thuluvath, Paul, Tobias, Hillel, Tomasiewicz, Krzysztof, Torres, Dawn, Trauner, Michael, Trautwein, Christian, Tsochatzis, Emanuel, Unitt, Esther, Vargas, Victor, Varkonyi, Istvan, Veitsman, Ella, Vespasiani Gentilucci, Umberto, Victor, David, Vierling, John, Vincent, Catherine, Vincze, Aron, von der Ohe, Manfred, Von Roenn, Natasha, Vuppalanchi, Raj, Waters, Michael, Watt, Kymberly, Weltman, Martin, Wieland, Amanda, Wiener, Gregory, Williams A, Alonzo, Williams J, Jeffrey, Wilson, Jason, Yataco, Maria, Yoshida, Eric, Younes, Ziad, Yuan, Liyun, Zivony, Adam, Zogg, Donald, Zoller, Heinz, Zoulim, Fabien, Zuckerman, Eli, Zuin, Massimo, and REGENERATE Study Investigators
- Subjects
Male ,Biopsy ,Clinical Trial, Phase III ,Administration, Oral ,030204 cardiovascular system & hematology ,Chronic liver disease ,Settore MED/04 ,Biomarkers/analysis ,Gastroenterology ,chemistry.chemical_compound ,0302 clinical medicine ,Liver Function Tests ,Non-alcoholic Fatty Liver Disease ,Clinical endpoint ,Medicine ,030212 general & internal medicine ,610 Medicine & health ,Chenodeoxycholic Acid/administration & dosage ,education.field_of_study ,Liver Function Test ,Research Support, Non-U.S. Gov't ,Fatty liver ,Obeticholic acid ,NASH, OBETICHOLIC ACID ,General Medicine ,Middle Aged ,Multicenter Study ,Randomized Controlled Trial ,Administration ,Female ,Biomarkers ,Chenodeoxycholic Acid ,Double-Blind Method ,Humans ,Human ,Oral ,medicine.medical_specialty ,Population ,Placebo ,03 medical and health sciences ,Research Support, N.I.H., Extramural ,Internal medicine ,Journal Article ,education ,Intention-to-treat analysis ,business.industry ,Biomarker ,Interim analysis ,medicine.disease ,Non-alcoholic Fatty Liver Disease/drug therapy ,chemistry ,Human medicine ,business - Abstract
© 2019 Elsevier Ltd. All rights reserved., Background: Non-alcoholic steatohepatitis (NASH) is a common type of chronic liver disease that can lead to cirrhosis. Obeticholic acid, a farnesoid X receptor agonist, has been shown to improve the histological features of NASH. Here we report results from a planned interim analysis of an ongoing, phase 3 study of obeticholic acid for NASH. Methods: In this multicentre, randomised, double-blind, placebo-controlled study, adult patients with definite NASH, non-alcoholic fatty liver disease (NAFLD) activity score of at least 4, and fibrosis stages F2-F3, or F1 with at least one accompanying comorbidity, were randomly assigned using an interactive web response system in a 1:1:1 ratio to receive oral placebo, obeticholic acid 10 mg, or obeticholic acid 25 mg daily. Patients were excluded if cirrhosis, other chronic liver disease, elevated alcohol consumption, or confounding conditions were present. The primary endpoints for the month-18 interim analysis were fibrosis improvement (≥1 stage) with no worsening of NASH, or NASH resolution with no worsening of fibrosis, with the study considered successful if either primary endpoint was met. Primary analyses were done by intention to treat, in patients with fibrosis stage F2-F3 who received at least one dose of treatment and reached, or would have reached, the month 18 visit by the prespecified interim analysis cutoff date. The study also evaluated other histological and biochemical markers of NASH and fibrosis, and safety. This study is ongoing, and registered with ClinicalTrials.gov, NCT02548351, and EudraCT, 20150-025601-6. Findings: Between Dec 9, 2015, and Oct 26, 2018, 1968 patients with stage F1-F3 fibrosis were enrolled and received at least one dose of study treatment; 931 patients with stage F2-F3 fibrosis were included in the primary analysis (311 in the placebo group, 312 in the obeticholic acid 10 mg group, and 308 in the obeticholic acid 25 mg group). The fibrosis improvement endpoint was achieved by 37 (12%) patients in the placebo group, 55 (18%) in the obeticholic acid 10 mg group (p=0·045), and 71 (23%) in the obeticholic acid 25 mg group (p=0·0002). The NASH resolution endpoint was not met (25 [8%] patients in the placebo group, 35 [11%] in the obeticholic acid 10 mg group [p=0·18], and 36 [12%] in the obeticholic acid 25 mg group [p=0·13]). In the safety population (1968 patients with fibrosis stages F1-F3), the most common adverse event was pruritus (123 [19%] in the placebo group, 183 [28%] in the obeticholic acid 10 mg group, and 336 [51%] in the obeticholic acid 25 mg group); incidence was generally mild to moderate in severity. The overall safety profile was similar to that in previous studies, and incidence of serious adverse events was similar across treatment groups (75 [11%] patients in the placebo group, 72 [11%] in the obeticholic acid 10 mg group, and 93 [14%] in the obeticholic acid 25 mg group). Interpretation: Obeticholic acid 25 mg significantly improved fibrosis and key components of NASH disease activity among patients with NASH. The results from this planned interim analysis show clinically significant histological improvement that is reasonably likely to predict clinical benefit. This study is ongoing to assess clinical outcomes.
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- 2019
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84. A Placebo-Controlled Trial of Bezafibrate in Primary Biliary Cholangitis.
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Corpechot, C., Chazouillères, O., Rousseau, A., Le Gruyer, A., Habersetzer, F., Mathurin, P., Goria, O., Potier, P., Minello, A., Silvain, C., Abergel, A., Debette-Gratien, M., Larrey, D., Roux, O., Bronowicki, J.-P., Boursier, J., de Ledinghen, V., Heurgue-Berlot, A., Nguyen-Khac, E., and Zoulim, F.
- Abstract
BACKGROUND Patients with primary biliary cholangitis who have an inadequate response to therapy with ursodeoxycholic acid are at high risk for disease progression. Fibrates, which are agonists of peroxisome proliferator-activated receptors, in combination with ursodeoxycholic acid, have shown potential benefit in patients with this condition. METHODS In this 24-month, double-blind, placebo-controlled, phase 3 trial, we randomly assigned 100 patients who had had an inadequate response to ursodeoxycholic acid according to the Paris 2 criteria to receive bezafibrate at a daily dose of 400 mg (50 patients), or placebo (50 patients), in addition to continued treatment with ursodeoxycholic acid. The primary outcome was a complete biochemical response, which was defined as normal levels of total bilirubin, alkaline phosphatase, aminotransferases, and albumin, as well as a normal prothrombin index (a derived measure of prothrombin time), at 24 months. RESULTS The primary outcome occurred in 31% of the patients assigned to bezafibrate and in 0% assigned to placebo (difference, 31 percentage points; 95% confidence interval, 10 to 50; P<0.001). Normal levels of alkaline phosphatase were observed in 67% of the patients in the bezafibrate group and in 2% in the placebo group. Results regarding changes in pruritus, fatigue, and noninvasive measures of liver fibrosis, including liver stiffness and Enhanced Liver Fibrosis score, were consistent with the results of the primary outcome. Two patients in each group had complications from end-stage liver disease. The creatinine level increased 5% from baseline in the bezafibrate group and decreased 3% in the placebo group. Myalgia occurred in 20% of the patients in the bezafibrate group and in 10% in the placebo group. CONCLUSIONS Among patients with primary biliary cholangitis who had had an inadequate response to ursodeoxycholic acid alone, treatment with bezafibrate in addition to ursodeoxycholic acid resulted in a rate of complete biochemical response that was significantly higher than the rate with placebo and ursodeoxycholic acid therapy. [ABSTRACT FROM AUTHOR]
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- 2018
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85. Parkinson’s disease and dysphagia
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Thevenot, T., Cattan, S., Nguyen-Khac, E., Ucla, E., Welty, S., and Bailleul, O.
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- 2003
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86. Doxorubicin-loaded nanoparticles for patients with advanced hepatocellular carcinoma after sorafenib treatment failure (RELIVE): a phase 3 randomised controlled trial
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Inmaculada Ales, Hakan Harputluoglu, Marc Peeters, Jean-Marc Phelip, G. Pelletier, Zsuzsanna Kahan, Alice Gangloff, Fadi Farhat, Imam Waked, Luc Lasser, René Gerolami, Giovanni Luca, Thomas Berg, Julie Le Boulicaut, Jean-Pierre Zarski, Ivan Borbath, Wolfgang Sieghart, Ozlem Ata, Howard Ozer, Julie Vincent, Thierry Fontanges, Bartomeu Massuti, Christos Galanopoulos, Mohammed El Kassas, Audrey Molé, Imam Wakid, Philippe Merle, Nasr El Lahlouby, Andreas Maieron, Marilyne Debette-Gratien, Antonio Cubillo, György Bodoky, Sylvain Manfredi, Faiza Khemissa-Akouz, Jawad Makarem, Jean-Frédéric Blanc, Ahmet Coker, Carmen Guillén, Massimo Colombo, Michael Schultheiß, Joerg Trojan, Yann Touchefeu, Isabelle Ollivier-Hourmand, François Habersetzer, Vlad Ratziu, Amr Abdel, Amr S Saad, Miguel Marín, Magdolna Dank, Mohamed Bouattour, Hélène Regnault, Jean-Didier Grangé, Pierluigi Toniutto, Hanaa Kohail, Sameh Shamaa, Carine Richou, Erdem Goker, Eric Nguyen-Khac, Oscar Alabiso, G.-P. Pageaux, Andrea Casadei-Gardini, Moses Raj, Alexander Zipprich, Henning Wege, Ilkay Tugba, Aurore Baron, Victor Navarro, Domenico Amoroso, Issam Chehade, Nashat Gabrail, Pierre Attali, Barbara Dauvois, Stefano Tamberi, Driffa Moussata, Angela Buonadonna, Emiliano Tamburini, Muhammet Ali, Armand Abergel, Albert Tran, Suayib Yalcin, Ursula Ehmer, Hermini Manzano, Jean Delwaide, Andrés Muñoz, Carlos López, Jean-Pierre Bronowicki, Zsolt Horváth, Alper Sevinc, Gloria Sánchez, Ralph Hauke, Gabriele Luppi, Bérangère Vasseur, Nelson S. Yee, Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Cellules Souches, Plasticité Cellulaire, Médecine Régénératrice et Immunothérapies (IRMB), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM), Microbes évolution phylogénie et infections (MEPHI), Institut de Recherche pour le Développement (IRD)-Aix Marseille Université (AMU)-Centre National de la Recherche Scientifique (CNRS), Assistance Publique - Hôpitaux de Marseille (APHM), Service d'Hépato-Gastro-Entérologie et Nutrition [CHU Limoges], CHU Limoges, Service d'Hépato-Gastroentérologie [CHU Rouen], Hôpital Charles Nicolle [Rouen], CHU Rouen, Normandie Université (NU)-Normandie Université (NU)-CHU Rouen, Normandie Université (NU)-Normandie Université (NU)-Université de Rouen Normandie (UNIROUEN), Normandie Université (NU), Université de Montpellier (UM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Assistance Publique-Hôpitaux de Marseille (AP-HM), Hôpital Charles Nicolle [Rouen]-CHU Rouen, UCL - SSS/IREC/GAEN - Pôle d'Hépato-gastro-entérologie, UCL - (SLuc) Service de gastro-entérologie, Merle, P., Blanc, J. -F., Phelip, J. -M., Pelletier, G., Bronowicki, J. -P., Touchefeu, Y., Pageaux, G., Gerolami, R., Habersetzer, F., Nguyen-Khac, E., Casadei-Gardini, A., Borbath, I., Tran, A., Wege, H., Saad, A. S., Colombo, M., Abergel, A., Richou, C., Waked, I., Yee, N. S., Mole, A., Attali, P., Le Boulicaut, J., Vasseur, B., Moussata, D., Grange, J. -D., Ratziu, V., Khemissa-Akouz, F., Regnault, H., Dauvois, B., Zarski, J. -P., Ollivier-Hourmand, I., Manfredi, S., Debette-Gratien, M., Gangloff, A., Fontanges, T., Baron, A., Bouattour, M., Vincent, J., Sieghart, W., Maieron, A., Peeters, M., Delwaide, J., Lasser, L., Berg, T., Schultheiss, M., Zipprich, A., Trojan, J., Ehmer, U., Luppi, G., Luca, G., Tamberi, S., Amoroso, D., Alabiso, O., Buonadonna, A., Toniutto, P., Tamburini, E., Cubillo, A., Munoz, A., Guillen, C., Sanchez, G., Manzano, H., Navarro, V., Ales, I., Massuti, B., Dank, M., Bodoky, G., Kahan, Z., Horvath, Z., Gabrail, N., Ozer, H., Galanopoulos, C., Hauke, R., Raj, M., Harputluoglu, H., Sevinc, A., Goker, E., Coker, A., Yalcin, S., Ali, M., Ata, O., Tugba, I., Elkassas, M., Abdel, A., Wakid, I., Shamaa, S., El, N., Kohail, H., Makarem, J., Chehade, I., Farhat, F., Lopez, C., and Marin, M.
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Male ,Gastroenterology ,law.invention ,0302 clinical medicine ,Randomized controlled trial ,law ,[SDV.MHEP.MI]Life Sciences [q-bio]/Human health and pathology/Infectious diseases ,Clinical endpoint ,Treatment Failure ,ComputingMilieux_MISCELLANEOUS ,education.field_of_study ,[SDV.MHEP.ME]Life Sciences [q-bio]/Human health and pathology/Emerging diseases ,Antibiotics, Antineoplastic ,Liver Neoplasms ,Middle Aged ,Sorafenib ,3. Good health ,030220 oncology & carcinogenesis ,Hepatocellular carcinoma ,[SDV.MP.VIR]Life Sciences [q-bio]/Microbiology and Parasitology/Virology ,030211 gastroenterology & hepatology ,Female ,medicine.drug ,medicine.medical_specialty ,Carcinoma, Hepatocellular ,Neutropenia ,Population ,Antineoplastic Agents ,03 medical and health sciences ,[SDV.MHEP.CSC]Life Sciences [q-bio]/Human health and pathology/Cardiology and cardiovascular system ,Internal medicine ,Carcinoma ,medicine ,Humans ,[SDV.MP.PAR]Life Sciences [q-bio]/Microbiology and Parasitology/Parasitology ,education ,Adverse effect ,Aged ,Hepatology ,Dose-Response Relationship, Drug ,business.industry ,medicine.disease ,Thrombocytopenia ,[SDV.MP.BAC]Life Sciences [q-bio]/Microbiology and Parasitology/Bacteriology ,Doxorubicin ,Asthenia ,Nanoparticles ,business - Abstract
Summary Background Cytotoxic chemotherapy is generally ineffective in patients with hepatocellular carcinoma. We assessed the intravenous perfusion of doxorubicin-loaded nanoparticles in patients with hepatocellular carcinoma in whom previous sorafenib therapy had failed. Methods We did a multicentre, open-label, randomised, controlled phase 3 trial at 70 sites in 11 countries. Patients with hepatocellular carcinoma with one or more previous systemic therapies, including sorafenib, were randomly assigned to receive 30 mg/m2 doxorubicin-loaded nanoparticles (30 mg/m2 group), 20 mg/m2 doxorubicin-loaded nanoparticles (20 mg/m2 group), or standard care using a computer-generated randomisation list prepared by the funder and stratified by geographic region. Patients in the experimental groups received perfusion of the drug every 4 weeks and those in the control group received any systemic anticancer therapy (except sorafenib) as per investigator decision. The primary endpoint was overall survival in the intention-to-treat population. Safety was assessed in the population of patients who received at least one dose of their assigned treatment. This trial is registered with ClinicalTrials.gov , number NCT01655693 . Findings Between June 15, 2012, and Jan 27, 2017, 541 patients were screened, of whom 144 were excluded and 397 were randomly assigned to one of the groups (133 to the 30 mg/m2 group; 130 to the 20 mg/m2 group; and 134 to the control group). Median follow-up was 22·7 months (IQR 11·2–34·9). After pooling the doxorubicin groups for the efficacy analysis, median overall survival was 9·1 months (95% CI 8·1–10·4) in the pooled doxorubicin-loaded nanoparticles group and 9·0 months (7·1–11·8) in the control group (HR 1·00 [95% CI 0·78–1·28], two-sided p=0·99). 227 (94%) of 242 patients who received doxorubicin-loaded nanoparticles and 100 (75%) of 134 patients in the control group had at least one treatment-emergent adverse event. The most common drug-related grade 3 or 4 treatment-emergent adverse events were neutropenia (25 [10%] of 242 treated with doxorubicin-loaded nanoparticles and eight [6%] of 134 in the control group), asthenia (six [2%] and four [3%]), and thrombocytopenia (three [1%] and ten [7%]). Six (2%) patients treated with doxorubicin-loaded nanoparticles and one (1%) of those in the control group were deemed by investigators to have had a drug-related death. Serious adverse events occurred in 74 (31%) patients who received doxorubicin-loaded nanoparticles and 48 (36%) in the control group. Interpretation Doxorubicin-loaded nanoparticles did not improve overall survival for patients with hepatocellular carcinoma in whom previous sorafenib treatment had failed. Funding Onxeo.
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- 2019
87. Elafibranor, an Agonist of the Peroxisome Proliferator-Activated Receptor-alpha and -delta, Induces Resolution of Nonalcoholic Steatohepatitis Without Fibrosis Worsening
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Dean W. Hum, T. Foster, Tarik Asselah, Mario Angelico, Antonio Craxì, Lawrence Serfaty, J. Gournay, Albert Geerts, Philippe Lehert, Javier Crespo, M. A. Huang, M. Voiculescu, Sven Francque, G. Abouda, Ulrich Beuers, David Cassiman, Manuel Romero-Gómez, Frederik Nevens, Philippe Mathurin, V. Clark, Sanjaya K. Satapathy, Dominique Larrey, Christophe Moreno, Arun J. Sanyal, Guruprasad P. Aithal, Pierre Bedossa, Terry Box, Guillermo E. Umpierrez, L. Preotescu, J. Gallegos-Orozco, Jean Henrion, Eric Nguyen-Khac, Steve Caldwell, J. L. Callera, M. Bourliere, Ulrich Spengler, R. K. Reddy, Bart Staels, Gyongyi Szabo, Fred Poordad, Muhammad Y. Sheikh, M. W. Moehlen, Raúl J. Andrade, Vlad Ratziu, V. de Ledinghen, Stephen A. Harrison, Juan Caballería, Manal F. Abdelmalek, Velimir A. Luketic, S. Megnien, A. Roudot, Jérôme Boursier, A. Tran, Aftab Ala, N. Shores, Rémy Hanf, Peter R. Galle, Quentin M. Anstee, M. Maynard-Muet, C. Chang, Liana Gheorghe, Joost P.H. Drenth, Stuart C. Gordon, Elisabetta Bugianesi, S. Parekh, Silvia Fargion, Kiran Bambha, John M. Vierling, Paul J. Pockros, Service d'Hépato-Gastro-Entérologie [CHU Pitié-Salpêtrière], CHU Pitié-Salpêtrière [AP-HP], Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Antwerp University Hospital [Edegem] (UZA), Service d'anatomie pathologique [CHU Tenon], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-CHU Tenon [AP-HP], Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Faculty of Medicine, University of Melbourne, Faculty of Economics, UcLouvain - Louvain School of Management - Campus Mons Management department, CHU Saint-Antoine [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Unit for The Clinical Management of Digestive Diseases and CIBERehd, Hospital Universitario de Valme, Anenida de Bellavista s/n, Sevilla 41014, Spain, Hémodynamique, Interaction Fibrose et Invasivité tumorales Hépatiques (HIFIH), Université d'Angers (UA), Radboud University Medical Center [Nijmegen], Newcastle University [Newcastle], Genfit, Entreprise biopharmaceutique GENFIT Loos, Récepteurs nucléaires, maladies cardiovasculaires et diabète - U 1011 (RNMCD), Institut Pasteur de Lille, Réseau International des Instituts Pasteur (RIIP)-Réseau International des Instituts Pasteur (RIIP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lille-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Institut National de la Santé et de la Recherche Médicale (INSERM), Université de Lille, European Genomic Institute for Diabetes - FR 3508 (EGID), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lille-Centre National de la Recherche Scientifique (CNRS), Virginia Commonwealth University (VCU), Ratziu V., Harrison S.A., Francque S., Bedossa P., Lehert P., Serfaty L., Romero-Gomez M., Boursier J., Abdelmalek M., Caldwell S., Drenth J., Anstee Q.M., Hum D., Hanf R., Roudot A., Megnien S., Staels B., Sanyal A., Mathurin P., Gournay J., Nguyen-Khac E., De Ledinghen V., Larrey D., Tran A., Bourliere M., Maynard-Muet M., Asselah T., Henrion J., Nevens F., Cassiman D., Geerts A., Moreno C., Beuers U.H., Galle P.R., Spengler U., Bugianesi E., Craxi A., Angelico M., Fargion S., Voiculescu M., Gheorghe L., Preotescu L., Caballeria J., Andrade R.J., Crespo J., Callera J.L., Ala A., Aithal G., Abouda G., Luketic V., Huang M.A., Gordon S., Pockros P., Poordad F., Shores N., Moehlen M.W., Bambha K., Clark V., Satapathy S., Parekh S., Reddy R.K., Sheikh M.Y., Szabo G., Vierling J., Foster T., Umpierrez G., Chang C., Box T., Gallegos-Orozco J., CHU Tenon [AP-HP], Institut Européen de Génomique du Diabète - European Genomic Institute for Diabetes - FR 3508 (EGID), and Réseau International des Instituts Pasteur (RIIP)-Réseau International des Instituts Pasteur (RIIP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lille-Centre National de la Recherche Scientifique (CNRS)
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0301 basic medicine ,Liver Cirrhosis ,Male ,Time Factors ,Intention to Treat Analysi ,[SDV]Life Sciences [q-bio] ,Biopsy ,PLACEBO-CONTROLLED TRIAL ,THERAPY ,Gastroenterology ,Severity of Illness Index ,Chalcone ,0302 clinical medicine ,Chalcones ,Non-alcoholic Fatty Liver Disease ,Gastrointestinal Agent ,Nonalcoholic fatty liver disease ,Propionate ,Medicine and Health Sciences ,Odds Ratio ,Medicine ,Glucose homeostasis ,VITAMIN-E ,education.field_of_study ,Gastrointestinal agent ,Fatty liver ,Remission Induction ,Middle Aged ,3. Good health ,Intention to Treat Analysis ,PPARD ,Europe ,Treatment Outcome ,Liver ,ACID ,PIOGLITAZONE ,030211 gastroenterology & hepatology ,Female ,PPARA ,Human ,Signal Transduction ,Adult ,CLINICAL-OUTCOMES ,medicine.medical_specialty ,Logistic Model ,Time Factor ,Liver Cirrhosi ,Population ,fatty liver ,NAFLD ,Biomarkers ,Double-Blind Method ,Gastrointestinal Agents ,Humans ,Logistic Models ,PPAR alpha ,PPAR gamma ,Propionates ,United States ,Placebo ,03 medical and health sciences ,Internal medicine ,education ,FATTY LIVER-DISEASE ,Hepatology ,business.industry ,Biomarker ,AMERICAN ASSOCIATION ,Odds ratio ,medicine.disease ,Confidence interval ,Renal disorders Radboud Institute for Molecular Life Sciences [Radboudumc 11] ,030104 developmental biology ,Endocrinology ,Human medicine ,business - Abstract
International audience; BACKGROUND & AIMS: Elafibranor is an agonist of the peroxisome proliferator-activated receptor-α and peroxisome proliferator-activated receptor-δ. Elafibranor improves insulin sensitivity, glucose homeostasis, and lipid metabolism and reduces inflammation. We assessed the safety and efficacy of elafibranor in an international, randomized, double-blind placebo-controlled trial of patients with nonalcoholic steatohepatitis (NASH).METHODS: Patients with NASH without cirrhosis were randomly assigned to groups given elafibranor 80 mg (n= 93), elafibranor 120 mg (n= 91), or placebo (n= 92) each day for 52 weeks at sites in Europe and the United States. Clinical and laboratory evaluations were performed every 2 months during this 1-year period. Liver biopsies were then collected and patients were assessed 3 months later. The primary outcome was resolution of NASH without fibrosis worsening, using protocol-defined and modified definitions. Data from the groups given the different doses of elafibranor were compared with those from the placebo group using step-down logistic regression, adjusting for baseline nonalcoholic fatty liver disease activity score.RESULTS: In intention-to-treat analysis, there was no significant difference between the elafibranor and placebo groups in the protocol-defined primary outcome. However, NASH resolved without fibrosis worsening in a higher proportion of patients in the 120-mg elafibranor group vs the placebo group (19% vs 12%; odds ratio= 2.31; 95% confidence interval: 1.02-5.24; P= .045), based on a post-hoc analysis for the modified definition. In post-hoc analyses of patients with nonalcoholic fatty liver disease activity score ≥4 (n= 234), elafibranor 120 mg resolved NASH in larger proportions of patients than placebo based on the protocol definition (20% vs 11%; odds ratio= 3.16; 95% confidence interval: 1.22-8.13; P= .018) and the modified definitions (19% vs 9%; odds ratio= 3.52; 95% confidence interval: 1.32-9.40; P= .013). Patients with NASH resolution after receiving elafibranor 120 mg had reduced liver fibrosis stages compared with those without NASH resolution (mean reduction of 0.65 ± 0.61 in responders for the primary outcome vs an increase of 0.10 ± 0.98 in nonresponders; P < .001). Liver enzymes, lipids, glucose profiles, and markers of systemic inflammation were significantly reduced in the elafibranor 120-mg group vs the placebo group. Elafibranor was welltolerated and did not cause weight gain or cardiac events, but did produce a mild, reversible increase in serum creatinine (effect size vs placebo: increase of 4.31 ± 1.19 μmol/L; P < .001).CONCLUSIONS: A post-hoc analysis of data from trial of patients with NASH showed that elafibranor (120 mg/d for 1 year) resolved NASH without fibrosis worsening, based on a modified definition, in the intention-to-treat analysis and in patients with moderate or severe NASH. However, the predefined end point was not met in the intention to treat population. Elafibranor was well tolerated and improved patients' cardiometabolic risk profile. ClinicalTrials.gov number: NCT01694849.
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- 2016
88. Liver disease in germline mutations of telomere-related genes: Prevalence, clinical, radiological, pathological features, outcome, and risk factors.
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Sidali S, Borie R, Sicre de Fontbrune F, El Husseini K, Rautou PE, Lainey E, Goria O, Crestani B, Cadranel J, Cottin V, Bunel V, Dumortier J, Jacquemin E, Reboux N, Hirschi S, Bourdin A, Meszaros M, Dharancy S, Hilaire S, Mallet V, Reynaud-Gaubert M, Terriou L, Gottrand F, Abou Chahla W, Khan JE, Carrier P, Saliba F, Rubbia-Brandt L, Aubert JD, Elkrief L, de Lédinghen V, Abergel A, Olivier T, Houssel P, Jouneau S, Wemeau L, Bergeron A, Leblanc T, Ollivier-Hourmand I, Nguyen Khac E, Morisse-Pradier H, Ba I, Boileau C, Roudot-Thoraval F, Vilgrain V, Bureau C, Nunes H, Naccache JM, Durand F, Francoz C, Roulot D, Valla D, Paradis V, Kannengiesser C, and Plessier A
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- Humans, Male, Female, Retrospective Studies, Middle Aged, Adult, Risk Factors, Prevalence, Aged, Young Adult, Telomere genetics, Adolescent, DNA Helicases, Liver Diseases genetics, Liver Diseases epidemiology, Liver Diseases pathology, Germ-Line Mutation, Telomerase genetics
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Background and Aim: Germline mutations of telomere-related genes (TRG) induce multiorgan dysfunction, and liver-specific manifestations have not been clearly outlined. We aimed to describe TRG mutations-associated liver diseases., Approach and Results: Retrospective multicenter analysis of liver disease (transaminases > 30 IU/L and/or abnormal liver imaging) in patients with TRG mutations. Main measurements were characteristics, outcomes, and risk factors of liver disease in a TRG mutations cohort. The prevalence of liver disease was compared to a community-based control group (n = 1190) stratified for age and matched 1:3 for known risk factors of liver disease. Among 132 patients with TRG mutations, 95 (72%) had liver disease, with associated lung, blood, skin, rheumatological, and ophthalmological TRG diseases in 82%, 77%, 55%, 39%, and 30% of cases, respectively. Liver biopsy was performed in 52/95 patients, identifying porto-sinusoidal vascular disease in 48% and advanced fibrosis/cirrhosis in 15%. After a follow-up of 21 months (12-54), ascites, hepato-pulmonary syndrome, variceal bleeding, and HCC occurred in 14%, 13%, 13%, and 2% of cases, respectively. Five-year liver transplantation-free survival was 69%. A FIB-4 score ≥ 3·25 and ≥1 risk factor for cirrhosis were associated with poor liver transplantation-free survival. Liver disease was more frequent in patients with TRG mutations than in the paired control group [80/396, (20%)], OR 12.9 (CI 95%: 7.8-21.3, p < 0.001)., Conclusions: TRG mutations significantly increase the risk of developing liver disease. Although symptoms may be mild, they may be associated with severe disease. Porto-sinusoidal vascular disease and cirrhosis were the most frequent lesions, suggesting that the mechanism of action is multifactorial., (Copyright © 2023 American Association for the Study of Liver Diseases.)
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- 2024
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89. Serum bile acids profiles are altered without change of the gut microbiota composition following a seven-day prednisolone therapy in severe alcoholic hepatitis.
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Esparteiro D, Fouquet G, Courtois A, Jedraszak G, Marticho L, Gourdel M, Billon-Crossouard S, Croyal M, Naassila M, Nguyen-Khac E, and Marcq I
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- Humans, Male, Middle Aged, Female, Retrospective Studies, Adult, Bacteria classification, Bacteria genetics, Bacteria isolation & purification, Bacteria drug effects, Fatty Acids, Volatile metabolism, Fatty Acids, Volatile blood, Carrier Proteins genetics, Carrier Proteins blood, Acute-Phase Proteins metabolism, Membrane Glycoproteins blood, Membrane Glycoproteins genetics, Aged, Metagenomics, Gastrointestinal Microbiome drug effects, Hepatitis, Alcoholic drug therapy, Hepatitis, Alcoholic blood, Feces microbiology, Feces chemistry, Bile Acids and Salts blood, Bile Acids and Salts metabolism, Prednisolone administration & dosage
- Abstract
Severe Alcoholic Hepatitis (sAH) is an acute form of liver injury caused by chronic and heavy alcohol drinking. A one-month corticosteroids course is the only sAH reference treatment, and its interactions with the Gut Microbiota (GM), which is a key contributor to liver injury, remain unknown. To evaluate the evolution of the GM in sAH patients, we retrospectively investigated the composition of the GM of 27 sAH patients at the Amiens University Hospital before (D0) and after (D7) a 7-day corticotherapy course using fecal metagenomics sequencing. We also quantified fecal Short-Chain Fatty Acids (SCFA) and fecal and serum Bile Acids (BA), as well as serum Lipopolysaccharide-Binding Protein (LBP). Overall, the community and taxonomical analyses did not reveal any GM evolution between D0 and D7, nor did the SCFA profiles analysis. However, in serum but not fecal samples, the ratio of glyco-conjugated to tauro-conjugated BA was significantly reduced at D7, independently of the response to treatment, while two BA were enriched in non-responder patients. LBP concentration significantly diminished between D0 and D7, which may indicate an improvement of the gut barrier. The stability of the GM of sAH is interesting in the perspective of new treatments based on GM modulation.
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- 2024
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90. Positive margins and plexitis increase the risk of recurrence after ileocecal resection: A systematic review and meta-analysis.
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Yzet C, Riault C, Brazier F, Grados L, Nguyen-Khac E, Chatelain D, Sabbagh C, Buisson A, Diouf M, and Fumery M
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- Humans, Prognosis, Neoplasm Recurrence, Local pathology, Cecum surgery, Cecum pathology, Margins of Excision, Recurrence, Retrospective Studies, Ileum surgery, Ileum pathology, Crohn Disease complications
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Introduction: There is debate over the impact of residual microscopic disease after ileocecal resection in Crohn's disease (CD) to predict recurrence. We conducted a meta-analysis to evaluate the impact of positive histological margins and plexitis after ileocecal resection on the risk of postoperative recurrence., Methods: Using a systematic search, we identified. 30 studies evaluating the impact of inflammatory margins on CD recurrence. The primary outcome was the postoperative clinical recurrence and secondary outcomes were surgical, and endoscopic recurrence. We performed random-effects meta-analysis and estimated odds ratio (OR) and 95% CIs., Results: Thirty studies were analyzed, seven focused on myenteric plexitis, six on submucosal plexitis and twenty-three on positive margins. Inflammatory margins were associated with a higher rate of clinical and surgical recurrences: respectively 14 studies - OR 2.38; 95% CI, 1.54 - 3.68- I2 = 68.2%, Q test-p = 0.0003 and 8 studies - OR, 1.52; 95% CI, 1.07-2.16 - I2 =0%; Q test-p = 0.43. The presence of myenteric plexitis was associated with a higher rate of clinical recurrence (4 studies- OR, 1.60; 95%CI, 1.12-2.29; I2= 0%, Q-test-p = 0.61), and of endoscopic recurrence (4 studies - OR, 4.25; 95%CI; 2.06-8.76; I2= 0%, Q test-p = 0.97). Submucosal plexitis was not associated with an increased risk of endoscopic recurrence (4 studies - OR, 0.94; 95%CI; 0.58-1.52; I2= 0%, Q test-p = 0.79)., Conclusion: Inflammatory margins and/or plexitis were associated with postoperative recurrence after ileocecal resection for CD. These elements should be taken into account in future algorithm for prevention of postoperative recurrence., Competing Interests: Conflict of interest CS: Research grants from AbbVie and Janssen CY: Galapagos, Abbvie, Takeda, Ferring MF: Abbvie, Ferring, MSD, Janssen, Takeda, Tillots, Pfizer, Gilead, Celgene, Galapagos, Biogen, Amgen, Viatris, Fresenius, and Boehringer. No conflict to declare for other authors, (Copyright © 2023 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.)
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- 2023
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91. Unresectable hepatocellular carcinoma at dawn of immunotherapy era: real-world data from the French prospective CHIEF cohort.
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Nguyen-Khac E, Nahon P, Ganry O, Ben Khadhra H, Merle P, Amaddeo G, Ganne-Carrie N, Silvain C, Peron JM, Mathurin P, Anty R, Uguen T, Decaens T, Riachi G, Bouattour M, Baron A, Bronowicki JP, Pageaux GP, Rosmorduc O, Ducournau G, Gilberg M, Tanang A, Dupin J, Gilbert-Marceau A, and Blanc JF
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- Humans, Bevacizumab adverse effects, Retrospective Studies, Quality of Life, Prospective Studies, Immunotherapy adverse effects, Carcinoma, Hepatocellular therapy, Carcinoma, Hepatocellular drug therapy, Liver Neoplasms therapy, Liver Neoplasms drug therapy, Chemoembolization, Therapeutic adverse effects, Chemoembolization, Therapeutic methods
- Abstract
Background and Objectives: Hepatocellular carcinoma epidemiological data are limited in France. The Epidemio Liver Immunotherapy Tecentriq outcome research (ELITor) retrospective study, based on real-world data from the Carcinome HépatocellulaIrE en France (CHIEF) French cohort of hepatocellular carcinoma patients, aimed to get insight into the treatment patterns, the sociodemographic, clinical, biological, and etiological characteristics, and the quality of life of patients with unresectable hepatocellular carcinoma., Methods and Results: Between 1 September 2019 and 4 December 2020, 367 patients from the CHIEF cohort received at least one locoregional (52.8%) chemoembolization or radioembolization or systemic treatment (88.3%) and were selected for ELITor. Most patients had a Barcelona Clinic Liver Cancer (BCLC) C (93.2%) hepatocellular carcinoma stage and were affected by cirrhosis (67.7%). Alcohol was confirmed as the main etiology both as a single etiology (29.1%) and in association with other risk factors (26.9%), mainly metabolic disorders (16.2%).Tyrosine-kinase inhibitors, mainly sorafenib, were the most administered systemic treatments in first line. Patients who received at least one combination of atezolizumab and bevacizumab during the study period ( N = 53) had a better performance status and less portal hypertension frequency than the overall population and more hepatitis B virus infection and fewer metabolic disorders as single etiology. Overall, the global health score before treatment (62.3 ± 21.9) was in line with that of reference cancer patients and worsened in 51.9% of the cases after first-line palliative-intent treatment., Conclusion: This study provided real-life data on advanced hepatocellular carcinoma characteristics and treatment patterns and described the first patients to receive the atezolizumab-bevacizumab combination before it became the new standard of care for advanced hepatocellular carcinoma., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)
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- 2023
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92. International survey among hepatologists and pulmonologists on the hepatic hydrothorax: plea for recommendations.
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Cadranel JD, Ollivier-Hourmand I, Cadranel J, Thevenot T, Zougmore H, Nguyen-Khac E, Bureau C, Allaire M, Nousbaum JB, Loustaud-Ratti V, Causse X, Sogni P, Hanslik B, Bourliere M, Peron JM, Ganne-Carrie N, Dao T, Thabut D, Maitre B, Debzi N, Smadhi R, Sombie R, Kpossou R, Nouel O, Bissonnette J, Ruiz I, Medmoun M, Dastis SN, Deltenre P, Artru F, Raherison C, Elkrief L, and Lemagoarou T
- Subjects
- Humans, Pulmonologists, Hydrothorax diagnosis, Hydrothorax etiology, Hydrothorax therapy, Gastroenterologists, Pleural Effusion diagnosis, Pleural Effusion etiology, Pleural Effusion therapy, Hypertension, Portal
- Abstract
Background: The Hepatic hydrothorax is a pleural effusion related to portal hypertension; its diagnosis and therapeutic management may be difficult. The aims of this article are which follows: To gather the practices of hepatogastroenterologists or pulmonologists practitioners regarding the diagnosis and management of the hepatic hydrothorax., Methods: Practitioners from 13 French- speaking countries were invited to answer an online questionnaire on the hepatic hydrothorax diagnosis and its management., Results: Five hundred twenty-eight practitioners (80% from France) responded to this survey. 75% were hepatogastroenterologists, 20% pulmonologists and the remaining 5% belonged to other specialities. The Hepatic hydrothorax can be located on the left lung for 64% of the responders (66% hepatogastroenterologists vs 57% pulmonologists; p = 0.25); The Hepatic hydrothorax can exist in the absence of clinical ascites for 91% of the responders (93% hepatogastroenterologists vs 88% pulmonologists; p = 0.27). An Ultrasound pleural scanning was systematically performed before a puncture for 43% of the responders (36% hepatogastroenterologists vs 70% pulmonologists; p < 0.001). A chest X-ray was performed before a puncture for 73% of the respondeurs (79% hepatogastroenterologists vs 54% pulmonologists; p < 0.001). In case of a spontaneous bacterial empyema, an albumin infusion was used by 73% hepatogastroenterologists and 20% pulmonologists (p < 0.001). A drain was used by 37% of the responders (37% hepatogastroenterologists vs 31% pulmonologists; p = 0.26).An Indwelling pleural catheter was used by 50% pulmonologists and 22% hepatogastroenterologists (p < 0.01). TIPS was recommended by 78% of the responders (85% hepatogastroenterologists vs 52% pulmonologists; p < 0.001) and a liver transplantation, by 76% of the responders (86% hepatogastroenterologists vs 44% pulmonologists; p < 0.001)., Conclusions: The results of this large study provide important data on practices of French speaking hepatogastroenterologists and pulmonologists; it appears that recommendations are warranted., (© 2023. BioMed Central Ltd., part of Springer Nature.)
- Published
- 2023
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93. Effect of Prophylactic Antibiotics on Mortality in Severe Alcohol-Related Hepatitis: A Randomized Clinical Trial.
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Louvet A, Labreuche J, Dao T, Thévenot T, Oberti F, Bureau C, Paupard T, Nguyen-Khac E, Minello A, Bernard-Chabert B, Anty R, Wartel F, Carbonell N, Pageaux GP, Hilleret MN, Moirand R, Nahon P, Potey C, Duhamel A, and Mathurin P
- Subjects
- Female, Humans, Male, Middle Aged, End Stage Liver Disease drug therapy, End Stage Liver Disease etiology, End Stage Liver Disease mortality, Hepatitis drug therapy, Hepatitis etiology, Hepatitis mortality, Prednisolone adverse effects, Prednisolone therapeutic use, Severity of Illness Index, Hospitalization, Anti-Inflammatory Agents adverse effects, Anti-Inflammatory Agents therapeutic use, Glucocorticoids adverse effects, Glucocorticoids therapeutic use, Adult, Amoxicillin-Potassium Clavulanate Combination administration & dosage, Amoxicillin-Potassium Clavulanate Combination adverse effects, Amoxicillin-Potassium Clavulanate Combination therapeutic use, Anti-Bacterial Agents administration & dosage, Anti-Bacterial Agents adverse effects, Anti-Bacterial Agents therapeutic use, Antibiotic Prophylaxis adverse effects, Antibiotic Prophylaxis methods, Antibiotic Prophylaxis mortality, Hepatitis, Alcoholic drug therapy, Hepatitis, Alcoholic etiology, Hepatitis, Alcoholic mortality
- Abstract
Importance: The benefits of prophylactic antibiotics for hospitalized patients with severe alcohol-related hepatitis are unclear., Objective: To determine the efficacy of amoxicillin-clavulanate, compared with placebo, on mortality in patients hospitalized with severe alcohol-related hepatitis and treated with prednisolone., Design, Setting, and Participants: Multicenter, randomized, double-blind clinical trial among patients with biopsy-proven severe alcohol-related hepatitis (Maddrey function score ≥32 and Model for End-stage Liver Disease [MELD] score ≥21) from June 13, 2015, to May 24, 2019, in 25 centers in France and Belgium. All patients were followed up for 180 days. Final follow-up occurred on November 19, 2019., Intervention: Patients were randomly assigned (1:1 allocation) to receive prednisolone combined with amoxicillin-clavulanate (n = 145) or prednisolone combined with placebo (n = 147)., Main Outcome and Measures: The primary outcome was all-cause mortality at 60 days. Secondary outcomes were all-cause mortality at 90 and 180 days; incidence of infection, incidence of hepatorenal syndrome, and proportion of participants with a MELD score less than 17 at 60 days; and proportion of patients with a Lille score less than 0.45 at 7 days., Results: Among 292 randomized patients (mean age, 52.8 [SD, 9.2] years; 80 [27.4%] women) 284 (97%) were analyzed. There was no significant difference in 60-day mortality between participants randomized to amoxicillin-clavulanate and those randomized to placebo (17.3% in the amoxicillin-clavulanate group and 21.3% in the placebo group [P = .33]; between-group difference, -4.7% [95% CI, -14.0% to 4.7%]; hazard ratio, 0.77 [95% CI, 0.45-1.31]). Infection rates at 60 days were significantly lower in the amoxicillin-clavulanate group (29.7% vs 41.5%; mean difference, -11.8% [95% CI, -23.0% to -0.7%]; subhazard ratio, 0.62; [95% CI, 0.41-0.91]; P = .02). There were no significant differences in any of the remaining 3 secondary outcomes. The most common serious adverse events were related to liver failure (25 in the amoxicillin-clavulanate group and 20 in the placebo group), infections (23 in the amoxicillin-clavulanate group and 46 in the placebo group), and gastrointestinal disorders (15 in the amoxicillin-clavulanate group and 21 in the placebo group)., Conclusion and Relevance: In patients hospitalized with severe alcohol-related hepatitis, amoxicillin-clavulanate combined with prednisolone did not improve 2-month survival compared with prednisolone alone. These results do not support prophylactic antibiotics to improve survival in patients hospitalized with severe alcohol-related hepatitis., Trial Registration: ClinicalTrials.gov Identifier: NCT02281929.
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- 2023
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94. Low alcohol consumption influences outcomes in individuals with alcohol-related compensated cirrhosis in a French multicenter cohort.
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Louvet A, Bourcier V, Archambeaud I, d'Alteroche L, Chaffaut C, Oberti F, Moreno C, Roulot D, Dao T, Moirand R, Duclos-Vallée JC, Goria O, Nguyen-Khac E, Pol S, Carbonell N, Gournay J, Elkrief L, Fouchard-Hubert I, Chevret S, and Ganne-Carrié N
- Subjects
- Male, Humans, Female, Prospective Studies, Liver Cirrhosis complications, Ethanol, Liver Cirrhosis, Alcoholic complications, Liver Neoplasms
- Abstract
Background & Aims: The harmful impact of heavy alcohol consumption and recurrence in patients with alcohol-related cirrhosis is long-established, although this is based on old studies. However, the drivers of long-term outcome still need to be clearly investigated., Method: All patients with biopsy-proven compensated alcohol-related cirrhosis included in the CIRRAL cohort (22 centers) were prospectively studied. Prognostic variables of survival and liver event-free survival were assessed using multivariable Cox models with stepwise selection. The prognostic impact of alcohol recurrence during follow-up (computed in glass-years in the same way as pack-years for tobacco) was assessed using a time-dependent covariable., Results: From 2010 to 2016, 650 patients were included. The median age at baseline was 58.4 years, 67.4% were men and the median BMI was 27.8 kg/m
2 , 63.8% had a history of liver decompensation, and 70.2% had discontinued alcohol. At 5 years, recurrence occurred in 30.9% of abstinent patients and this risk was higher in patients with a history of drug abuse and in those with shorter alcohol discontinuation times. Median survival was 97 months. Age, alcohol consumption at baseline, platelet count and Child-Pugh score >5 were associated with overall and liver event-free survival on multivariate analysis. Alcohol consumption of more than 25 glass-years during follow-up was independently associated with lower survival and with a trend toward lower liver event-free survival, with the risk increasing from 1 glass-year, though not significantly. Simon & Makuch plots confirm the benefit of no alcohol consumption (<1 glass/week) on both outcomes and the dose-dependent impact of alcohol over time., Conclusion: This prospective study in patients with compensated alcohol-related cirrhosis identifies factors predictive of alcohol recurrence during follow-up and shows that moderate alcohol consumption during follow-up negatively impacts outcomes. Patients with alcohol-related cirrhosis should be advised to completely stop drinking alcohol., Registration: CIRRAL (NCT01213927) cohort was registered at ClinicalTrials.gov and the full protocol is available at the following link: https://clinicaltrials.gov/ct2/show/NCT01213927., Impact and Implications: In patients with alcohol-related cirrhosis, data are lacking about the impact of the amount of alcohol consumed on both survival and liver-related events. The present study based on the CIRRAL cohort demonstrates that alcohol recurrence occurs in more than 30% of patients with compensated cirrhosis and that even a moderate recurrence strongly influences outcomes. Patients with compensated alcohol-related cirrhosis should be advised to completely discontinue alcohol consumption, even in small amounts, as the present study shows that no alcohol consumption can be regarded as safe when cirrhosis has developed., (Copyright © 2022 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.)- Published
- 2023
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95. Correction: Endoscopic treatment of large gastric leaks after gastrectomy using the combination of double pigtail drains crossing a covered stent.
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Yzet C, Hakim S, Pioche M, Le Mouel JP, Deschepper C, Lafeuille P, Delcenserie R, Yzet T, Nguyen-Khac E, Fumery M, and Brazier F
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- 2023
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96. Endoscopic treatment of large gastric leaks after gastrectomy using the combination of double pigtail drains crossing a covered stent.
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Yzet C, Hakim S, Pioche M, Le Mouel JP, Deschepper C, Lafeuille P, Delcenserie R, Yzet T, Nguyen-Khac E, Fumery M, and Brazier F
- Subjects
- Humans, Retrospective Studies, Anastomotic Leak etiology, Anastomotic Leak surgery, Gastrectomy adverse effects, Gastrectomy methods, Stents adverse effects, Treatment Outcome, Endoscopy, Gastrointestinal adverse effects, Fistula complications, Obesity, Morbid surgery
- Abstract
Background: Endoscopy is the gold standard for the treatment of postoperative gastric leaks (GL). Large fistulas are associated with high rate of treatment failure. The objective of this study was to assess the clinical efficacy of a combining technique using a covered stent (CS) crossing through pigtails (PDs) for large postsurgical GL leaks., Methods: All consecutive patients with large (> 10 mm) postsurgical GL treated endoscopically with a combination of a CS and PDs were included in a single-center retrospective study. The primary endpoint was the rate of GL closure., Results: A total of 29 patients were included. Twenty-five patients underwent sleeve gastrectomy. The fistula (median diameter 15 mm) was diagnosed 6 days (IQR 4-9) after surgery. Technical success was observed in all procedures. After a median follow-up of 10.7 months (IQR 3.8-20.7), GL closure was observed in 82.7% with a median time of 63 days (IQR 40-90). Surgical management was finally necessary in four patients after a median of 186 days (IQR 122-250). No complications related to combined endoscopic treatment were observed especially stent migration during the follow-up., Conclusion: An endoscopic strategy combining CS crossing through PDs appears to be effective, safe and well tolerated for the treatment of large GL., (© 2022. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)
- Published
- 2022
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97. Neo-Adjuvant Use of Sorafenib for Hepatocellular Carcinoma Awaiting Liver Transplantation.
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Minoux K, Lassailly G, Ningarhari M, Lubret H, El Amrani M, Canva V, Truant S, Mathurin P, Louvet A, Lebuffe G, Goria O, Nguyen-Khac E, Boleslawski E, and Dharancy S
- Subjects
- Humans, Sorafenib therapeutic use, Neoadjuvant Therapy, Carcinoma, Hepatocellular drug therapy, Carcinoma, Hepatocellular surgery, Liver Transplantation adverse effects, Liver Neoplasms drug therapy, Liver Neoplasms surgery
- Abstract
Data on efficacy and safety of sorafenib in a neoadjuvant setting for HCC awaiting liver transplantation (LT) are heterogeneous and scarce. We aimed to investigate the trajectory of patients treated with sorafenib while awaiting LT. All patients listed for HCC and treated with sorafenib were included in a monocentric observational study. A clinical and biological evaluation was performed every month. Radiological tumor response evaluation was realized every 3 months on the waiting list and every 6 months after LT. Among 327 patients listed for HCC, 62 (19%) were treated with Sorafenib. Sorafenib was initiated for HCC progression after loco-regional therapy (LRT) in 50% of cases and for impossibility of LRT in 50% of cases. The mean duration of treatment was 6 months. Thirty six patients (58%) dropped-out for tumor progression and 26 (42%) patients were transplanted. The 5-year overall and recurrent-free survival after LT was 77% and 48% respectively. Patients treated for impossibility of LRT had acceptable 5-year intention-to-treat overall and post-LT survivals. Conversely, patients treated for HCC progression presented high dropout rate and low intention-to-treat survival. Our results suggest that it is very questionable in terms of utility that patients treated for HCC progression should even be kept listed once the tumor progression has been observed., Competing Interests: SD reports receiving lecture fees from Novartis, Sandroz, Intercept, Astellas, Roche, Ipsen and Abbvie and serving as a board member of Novartis and Biotest. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Minoux, Lassailly, Ningarhari, Lubret, El Amrani, Canva, Truant, Mathurin, Louvet, Lebuffe, Goria, Nguyen-Khac, Boleslawski and Dharancy.)
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- 2022
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98. Alfapump ® implantable device in management of refractory ascites: An update.
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Weil-Verhoeven D, Di Martino V, Stirnimann G, Cervoni JP, Nguyen-Khac E, and Thévenot T
- Abstract
Refractory ascites (RA) is a frequent and life-threatening complication of cirrhosis. In selected patients with RA, transjugular intrahepatic portosystemic shunt (TIPS) placement and liver transplantation (LT) are currently considered the best therapeutic alternatives to repeated large volume paracentesis. In patients with a contraindication to TIPS or LT, the alfapump
® system (Sequana Medical, Ghent, Belgium) has been developed to reduce the need for iterative paracentesis, and consequently to improve the quality of life and nutritional status. We report here recent data on technical progress made since the first implantation, the efficacy and tolerance of the device, the position of the pump in the therapeutic arsenal for refractory ascites, and the grey areas that remain to be clarified regarding the optimal selection of patients who are potential candidates for this treatment., Competing Interests: Conflict-of-interest statement: Stirnimann G has received support for travel and meeting attendance, served as a speaker, and participated in Advisory Boards for Sequana Medical. There is no conflict of interest associated with any of the senior author or other coauthors contributed their efforts in this manuscript., (©The Author(s) 2022. Published by Baishideng Publishing Group Inc. All rights reserved.)- Published
- 2022
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99. ABO blood group does not influence Child-Pugh A cirrhosis outcome: An observational study from CIRRAL and ANRS CO12 CIRVIR cohorts.
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Ollivier-Hourmand I, Repesse Y, Nahon P, Chaffaut C, Dao T, Nguyen TTN, Marcellin P, Roulot D, De Ledinghen V, Pol S, Guyader D, Archambeaud I, Zoulim F, Oberti F, Tran A, Bronowicki JP, D'Alteroche L, Ouzan D, Peron JM, Zarski JP, Bourliere M, Larrey D, Louvet A, Cales P, Abergel A, Mathurin P, Mallat A, Blanc JF, Nguyen-Khac E, Riachi G, Alric L, Serfaty L, Antonini T, Moreno C, Attali P, Thabut D, Pilette C, Grange JD, Silvain C, Carbonell N, Bernard-Chabert B, Goria O, Wartelle C, Moirand R, Christidis C, Perlemuter G, Ozenne V, Henrion J, Hillaire S, Di Martino V, Amiot X, Sutton A, Barget N, Chevret S, and Ganne-Carrie N
- Subjects
- Disease Progression, Humans, Liver Cirrhosis, Prospective Studies, ABO Blood-Group System, Hypertension, Portal complications
- Abstract
Background and Aims: Non-O blood group promotes deep vein thrombosis and liver fibrosis in both general population and hepatitis C. We aimed to evaluate the influence of Non-O group on the outcome of Child-Pugh A cirrhotic patients., Methods: We used two prospective cohorts of Child-Pugh A cirrhosis due to either alcohol or viral hepatitis. Primary end point was the cumulated incidence of 'Decompensation' at 3 years, defined as the occurrence of ascites , hydrothorax, encephalopathy, gastrointestinal bleeding related to portal hypertension, or bilirubin >45 μmol/L. Secondary end points were the cumulated incidences of (1) 'Disease Progression' including a « decompensation» or « the occurrence of one or more parameters » among: prothrombin time (PT) <45%, albumin <28 g/L, Child-Pugh worsening (B or C vs A or B, C vs B), hepatorenal syndrome, and hepato-pulmonary syndrome, (2) other events such as non-malignant portal vein thrombosis (nmPVT), and (3) overall survival., Results: Patients (n = 1789; 59.9% Non-O group; 40.1% group O) were followed during a median of 65.4 months. At 3 years cumulated incidence of Decompensation was 8.3% in Non-O group and 7.2% in group O (P = .27). Cumulated incidence of Disease Progression was 20.7% in Non-O group and 18.9% in group O (P = .26). Cumulated incidence of nmPVT was 2.7% in Non-O group and 2.8% in group O (P = .05). At 3 years overall survival was 92.4% in Non-O group and 93.4% in group O (P = 1)., Conclusion: Non-O group does not influence disease outcome in Child-Pugh A cirrhotic patients. Clinicals trial number NCT03342170., (© 2022 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.)
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- 2022
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100. Management of alcohol-related liver disease: the French Association for the Study of the Liver and the French Alcohol Society clinical guidelines.
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Louvet A, Trabut JB, Moreno C, Moirand R, Aubin HJ, Ntandja Wandji LC, Nourredine M, Ningarhari M, Ganne-Carrié N, Pageaux GP, Bailly F, Boursier J, Daeppen JB, Luquiens A, Nguyen-Khac E, Anty R, Orban T, Donnadieu-Rigole H, Mallat A, Bureau C, Pariente EA, Paupard T, Benyamina A, Perney P, Mathurin P, and Rolland B
- Subjects
- Ethanol, France epidemiology, Humans, Liver Diseases etiology, Liver Diseases therapy
- Abstract
Excessive alcohol consumption is the leading cause of liver diseases in Western countries, especially in France. Alcohol-related liver disease (ARLD) is an extremely broad context and there remains much to accomplish in terms of identifying patients, improving prognosis and treatment, and standardising practices. The French Association for the Study of the Liver wished to organise guidelines together with the French Alcohol Society in order to summarise the best evidence available about several key clinical points in ARLD. These guidelines have been elaborated based on the level of evidence available in the literature and each recommendation has been analysed, discussed and voted by the panel of experts. They describe how patients with ARLD should be managed nowadays and discuss the main unsettled issues in the field., (© 2022 John Wiley & Sons A/S . Published by John Wiley & Sons Ltd.)
- Published
- 2022
- Full Text
- View/download PDF
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