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1. 128 - TENDENCIAS TEMPORALES DE PRESCRIPCIÓN DE TRATAMIENTOS ERRADICADORES Y DE SU EFECTIVIDAD EN PACIENTES NAÏVE EN ESPAÑA ENTRE 2013 Y 2022: 10 AÑOS DE EXPERIENCIA DEL REGISTRO EUROPEO SOBRE EL MANEJO DE LA INFECCIÓN POR H. PYLORI (HP-EUREG)

Author

Luis Hernández, Maria Ángeles Pérez-Aisa, Samuel Jesús Martínez- Domínguez, Manuel Pabón-Carrasco, Luis Bujanda, Alfredo Lucendo, Luis Rodrigo, Ana Garre, Jose María Huguet, Noelia Alcaide, Mónica Perona, Jesús Barrio, Óscar Núñez, Javier Tejedor Tejada, Pilar Mata, Diego Ledro, Juan Ortuño, Manuel Dominguez Cajal, Gema Ladrón, Judith Gómez Camarero, Blas José Gómez Rodríguez, Olga P. Nyssen, Francis Megraud, Colm O’Morain, and Javier P. Gisbert

Subjects
Hepatology, Gastroenterology
Published
2023
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2. 139 - EFECTIVIDAD EN SEGUNDA LÍNEA DE TRATAMIENTO FRENTE A HELICOBACTER PYLORI: SUBANÁLISIS DE LOS DATOS ESPAÑOLES DEL REGISTRO EUROPEO SOBRE EL MANEJO DE LA INFECCIÓN POR H. PYLORI (HPEUREG)

Author

Luis Hernández, Maria Ángeles Pérez-Aisa, Samuel Jesús Martínez- Domínguez, Manuel Pabón-Carrasco, Luis Bujanda, Alfredo Lucendo, Luis Rodrigo, Ana Garre, Jose María Huguet, Noelia Alcaide, Mónica Perona, Jesús Barrio, Óscar Núñez, Javier Tejedor Tejada, Pilar Mata, Diego Ledro, Juan Ortuño, Manuel Domínguez Cajal, Gema Ladrón, Judith Gómez Camarero, Blas José Gómez Rodríguez, Olga P. Nyssen, Francis Megraud, Colm O’Morain, and Javier P. Gisbert

Subjects
Hepatology, Gastroenterology
Published
2023
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3. 138 - EFECTIVIDAD EN PRIMERA LÍNEA DE TRATAMIENTO FRENTE A HELICOBACTER PYLORI: SUBANÁLISIS DE LOS DATOS ESPAÑOLES DEL REGISTRO EUROPEO SOBRE EL MANEJO DE LA INFECCIÓN POR H. PYLORI (HPEUREG)

Author

Luis Hernández, Maria Ángeles Pérez-Aisa, Samuel Jesús Martínez- Domínguez, Manuel Pabón-Carrasco, Luis Bujanda, Alfredo Lucendo, Luis Rodrigo, Ana Garre, Jose María Huguet, Noelia Alcaide, Mónica Perona, Jesús Barrio, Óscar Núñez, Javier Tejedor Tejada, Pilar Mata, Diego Ledro, Juan Ortuño, Manuel Domínguez Cajal, Gema Ladrón, Judith Gómez Camarero, Blas José Gómez Rodríguez, Olga P. Nyssen, Francis Megraud, Colm O’Morain, and Javier P. Gisbert

Subjects
Hepatology, Gastroenterology
Published
2023
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4. 135 - TENDENCIAS DE PRESCRIPCIÓN DE TRATAMIENTOS ERRADICADORES Y DE SU EFECTIVIDAD EN PACIENTES NAÏVE A LO LARGO DE 10 AÑOS (2013-2022) EN EUROPA: DATOS DEL REGISTRO EUROPEO SOBRE EL MANEJO DE LA INFECCIÓN POR HELICOBACTER PYLORI (HP-EUREG)

Author

Olga P. Nyssen, Laimas Jonaitis, Ángeles Pérez-Aísa, Dino Vaira, Giulia Fiorini, Ilaria Maria Saracino, Bojan Tepes, Dmitry Bordin, Alma Keco- Huerga, Manuel Castro-Fernández, Alfredo Lucendo, Liudmila Vologzhanina, Luis Bujanda, Natasa Brglez Jurecic, Maja Denkovski, Angel Lanas, Samuel Martínez-Dominguez, Enrique Alfaro, Marcis Leja, Renate Bumane, Emin Mammadov, Gulustan Babayeva, Umud Mahmudov, María Caldas, Luis Rodrigo, Frode Lerang, Galyna Fadieienko, Rustam Abdulkhakov, Jose María Huguet Malavés, Oleg Zaytsev, Tatiana Ilchishina, Luis Fernández-Salazar, Noelia Alcaide, Benito Velayos, Aiman Silkanovna Sarsenbaeva, Igor Bakulin, Antonietta G. Gravina, Marco Romano, Mónica Perona, Sergey Alekseenko, Jesús Barrio, Miguel Areia, Óscar Nuñez, Pavel Bogomolov, Blas José Gómez Rodríguez, Manuel Dominguez- Cajal, Judith Gomez Camarero, Manuel Jiménez Moreno, Sotirios Georgopoulos, Pedro Almela Notari, Ante Tonkic, Rinaldo Pellicano, Halis Simsek, Lumír Kunovský, Antonio Gasbarrini, Jose Maria Botargues Bote, Gyorgy M Buzas, Miguel Fernández-Bermejo, Perminder Phull, Marino Venerito, Peter Malfertheiner, Rosa Rosania, Alexander Link, Eduardo Iyo, Juozas Kupinskas, Oleg Shvets, Ricardo Marcos Pinto, Theodore Rokkas, Ilkay Simsek, Sinead Smith, Doron Boltin, Dominique Lamarque, Daniela Dobru, Wojciech Marlicz, Vladimir Milivojevic, Lyudmila Boyanova, Vincent Lamy, Michael Doulberis, Peter Bytzer, Lisette Capelle, Oleksiy Gridnyev, Ari Ristimaki, Anna Cano-Català, Ignasi Puig, Francis Mégraud, Colm O’Morain, and Javier P. Gisbert

Subjects
Hepatology, Gastroenterology
Published
2023
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7. 881: BUDESONIDE ORODISPERSIBLE TABLETS MAINTAIN CLINICAL, HISTOLOGICAL AND ENDOSCOPIC REMISSION IN ADULT PATIENTS WITH EOSINOPHILIC ESOPHAGITIS: RESULTS FROM THE 96-WEEKS OPEN-LABEL EXTENSION PHASE FOLLOWING THE 1-YEAR DOUBLE-BLIND EOS-2 TRIAL

Author

Christoph Schlag, Alex Straumann, Alfredo Lucendo, Stephan Miehlke, Michael Vieth, Luc Biedermann, Cecilio Santander, Constanza Ciriza De Los Ríos, Christoph Schmöcker, Ahmed Madisch, Petr Hruz, Jamal O. Hayat, Ulrike Von Arnim, Arjan Bredenoord, Stefan Schubert, Ralph Mueller, Roland Greinwald, Alain M. Schoepfer, and Stephen E. Attwood

Subjects
Hepatology, Gastroenterology
Published
2022
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8. 867a: CLINICAL AND HISTOLOGICAL IMPROVEMENTS WITH WEEKLY DUPILUMAB TREATMENT IN ADULT AND ADOLESCENT PATIENTS WITH EOSINOPHILIC ESOPHAGITIS AT WEEK 24: WEEKLY AND EVERY 2 WEEKS’ RESULTS FROM PART B OF THE 3-PART LIBERTY EOE TREET STUDY

Author

Evan S. Dellon, Marc E. Rothenberg, Arjan Bredenoord, Margaret H. Collins, Ikuo Hirano, Mirna Chehade, Alfredo Lucendo, Jonathan Spergel, Xian Sun, Jennifer D. Hamilton, Eilish McCann, Leda Mannent, Bolante Akinlade, Elizabeth Laws, Jennifer Maloney, Kiran Patel, Bethany Beazley, Angeliki Giannelou, and Arsalan Shabbir

Subjects
Hepatology, Gastroenterology
Published
2022
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9. Budesonide orodispersible tablets maintain remission in a randomized, placebo-controlled trial of patients with eosinophilic esophagitis

Author

Alex Straumann, Alfredo J. Lucendo, Stephan Miehlke, Michael Vieth, Christoph Schlag, Luc Biedermann, Cecilio Santander Vaquero, Constanza Ciriza de los Rios, Christoph Schmoecker, Ahmed Madisch, Petr Hruz, Jamal Hayat, Ulrike von Arnim, Albert Jan Bredenoord, Stefan Schubert, Ralph Mueller, Roland Greinwald, Alain Schoepfer, Stephen Attwood, Jan Tack, Monther Bajbouj, Stefan Brückner, Christiane Fibbe, Sebastian Haag, Christoph Schmöcker, Dirk Hartmann, Frank Lammert, Max Reinshagen, Norbert Börner, Dieter Witzemann, Karel Caca, Jörg Albert, Stefan Zeuzem, Felix Wiedbrauck, Helmut Messmann, Robert Verdonk, Franciscus Wolfhagen, Alfredo Lucendo Villarin, Constanza Ciriza de los Ríos, Antonia Perelló Juan, Isabel Perez Martinez, Joaquin Rodriguez Sanchez-Migallon, Jesús Barrio Andrés, ÁngelesPérez Aisa, Anjan Dhar, Gastroenterology and Hepatology, and AGEM - Amsterdam Gastroenterology Endocrinology Metabolism

Subjects
0301 basic medicine, Budesonide, Adult, Male, medicine.medical_specialty, Time Factors, Patient-Reported Outcomes, Dose, Remission, medicine.drug_class, Placebo-controlled study, Proton-pump inhibitor, Administration, Oral, Placebo, Gastroenterology, Topical Corticosteroids, 03 medical and health sciences, 0302 clinical medicine, Double-Blind Method, Adrenal Cortex Hormones, Internal medicine, medicine, Humans, ddc:610, Eosinophilic esophagitis, Adverse effect, Hepatology, business.industry, Remission Induction, Dysphagia, Eosinophilic Esophagitis, Middle Aged, medicine.disease, Europe, 030104 developmental biology, Treatment Outcome, 030211 gastroenterology & hepatology, Female, medicine.symptom, business, medicine.drug, Tablets
Abstract

Background & Aims: Eosinophilic esophagitis (EoE) is a chronic inflammatory disorder. Swallowed topical-acting corticosteroids are effective in bringing active EoE into remission. However, it is not clear whether these drugs are effective for long-term maintenance of remission. Methods: We performed a double-blind trial to compare the efficacy and safety of 2 dosages of a budesonide orodispersible tablet (BOT) vs placebo in maintaining remission of EoE. Maintenance of remission was defined as absence of clinical and histologic relapse and no premature withdrawal for any reason. Two hundred and four adults with EoE in clinical and histologic remission, from 29 European study sites, were randomly assigned to groups given BOT 0.5 mg twice daily (n = 68), BOT 1.0 mg twice daily (n = 68), or placebo twice daily (n = 68) for up to 48 weeks. Results: At end of treatment, 73.5% of patients receiving BOT 0.5 mg twice daily and 75% receiving BOT 1.0 mg twice daily were in persistent remission compared with 4.4% of patients in the placebo group (P < .001 for both comparisons of BOT with placebo). Median time to relapse in the placebo group was 87 days. The frequency of adverse events was similar in the BOT and placebo groups. Morning serum levels of cortisol were in the normal range at baseline and did not significantly change during treatment. Four patients receiving BOT developed asymptomatic, low serum levels of cortisol. Clinically manifested candidiasis was suspected in 16.2% of patients in the BOT 0.5 mg group and in 11.8% of patients in the BOT 1.0 mg group; all infections resolved with treatment. Conclusions: In a phase 3 trial, up to 48 weeks of treatment with BOT (0.5 mg or 1.0 mg twice daily) was superior to placebo in maintaining remission of EoE. Both dosages were equally effective and well tolerated. EudraCT number; 2014-001485-99; ClinicalTrials.gov number, NCT02434029.

Published
2020

10. Efficacy of Budesonide Orodispersible Tablets as Induction Therapy for Eosinophilic Esophagitis in a Randomized Placebo-Controlled Trial

Author

Alfredo J. Lucendo, Stephan Miehlke, Christoph Schlag, Michael Vieth, Ulrike von Arnim, Javier Molina-Infante, Dirk Hartmann, Albert Jan Bredenoord, Constanza Ciriza de los Rios, Stefan Schubert, Stefan Brückner, Ahmed Madisch, Jamal Hayat, Jan Tack, Stephen Attwood, Ralph Mueller, Roland Greinwald, Alain Schoepfer, Alex Straumann, Tim Vanuytsel, Hubert Louis, Carmen Musala, Dorothea Frederking, Monther Bajbouj, Simon Nennstiel, Renate Schmelz, Schmelz Heimerl, Anna-Magdalena Stephan, Christiane Fibbe, Niels Liedtke (née Laschinsky), Jutta Keller, Ulrich Rosien, Sebastian Haag, Arne Schneider, Christoph Schmöcker, Hendrik Buchholz, Frank Lammert, Markus Casper, Matthias Reichert, Dirk Sommer, Hubert Mönnikes, Miriam Stengel, Marco Schmidtmann, Michaela Müller, Alexander Eckardt, Till Wehrmann, Peter Armerding, Wolf Peter Hofmann, Thomas Liceni, Arne Kandulski, Jochen Weigt, Norbert Börner, Anne Lutz-Vorderbrügge, Jörg Albert, Stefan Zeuzem, Irina Blumenstein, Kathrin Sprinzl, Johannes Hausmann, Arjan Bredenoord, Marijn Warners, Alfredo Lucendo Villarin, Ángel Arias Arias, Maria Ángeles Tejero Bustos, María Jesús Carrillo Ramos, José María Olalla Gallardo, Rocío Juárez Tosina, José Zamorano, Cecilio Santander Vaquero, Sergio Casabona Francés, Teresa Pérez, Teresa Rodriguez, Constanza Ciriza de los Ríos, Fernando Canga Rodríguez-Valcárcel, Isabel Castel de Lucas, Antonia Perelló Juan, Merce Barenys, Carlos Pons, Isabel Perez Martinez, M. Eugenia Lauret, Andrés Castaño García, Esmeralda Rubio, Petr Hruz, Simon Brunner, Andrew Poullis, Gastroenterology and Hepatology, AGEM - Digestive immunity, and AGEM - Endocrinology, metabolism and nutrition

Subjects
0301 basic medicine, Budesonide, Adult, Male, medicine.medical_specialty, Antifungal Agents, phase 3 trial, Placebo-controlled study, Administration, Oral, Placebo, Gastroenterology, immune response, law.invention, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, Double-Blind Method, law, Candidiasis, Oral, Internal medicine, medicine, Clinical endpoint, Humans, Eosinophilic esophagitis, Glucocorticoids, esophagus, Hepatology, business.industry, Eosinophilic Esophagitis, Middle Aged, medicine.disease, ddc, 030104 developmental biology, Treatment Outcome, Tolerability, patient-reported outcomes, 030211 gastroenterology & hepatology, Female, Esophagoscopy, medicine.symptom, business, Odynophagia, medicine.drug, Tablets
Abstract

BACKGROUND & AIMS: Swallowed topical-acting corticosteroids are recommended as first-line therapy for eosinophilic esophagitis (EoE). Asthma medications not optimized for esophageal delivery are sometimes effective, although given off-label. We performed a randomized, placebo-controlled trial to assess the effectiveness and tolerability of a budesonide orodispersible tablet (BOT), which allows the drug to be delivered to the esophagus in adults with active EoE. METHODS: We performed a double-blind, parallel study of 88 adults with active EoE in Europe. Patients were randomly assigned to groups that received BOT (1 mg twice daily; n = 59) or placebo (n = 29) for 6 weeks. The primary end point was complete remission, based on clinical and histologic factors, including dysphagia and odynophagia severity ≤2 on a scale of 0-10 on each of the 7 days before the end of the double-blind phase and a peak eosinophil count

Published
2019

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