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1. Role of compliance in Helicobacter pylorieradication treatment: Results of the European Registry on H. pylorimanagement

Author: Huguet, Jose M., Ferrer‐Barceló, Luis, Suárez, Patrícia, Barcelo‐Cerda, Susana, Sempere, Javier, Saracino, Ilaria Maria, Fiorini, Giulia, Vaira, Dino, Pérez‐Aísa, Ángeles, Jonaitis, Laimas, Tepes, Bojan, Castro‐Fernandez, M., Pabón‐Carrasco, Manuel, Keco‐Huerga, Alma, Voynovan, Irina, Lucendo, Alfredo J., Lanas, Ángel, Martínez‐Domínguez, Samuel J., Alfaro Almajano, Enrique, Rodrigo, Luis, Vologzanina, Ludmila, Bordin, Dmitry S., Gasbarrini, Antonio, Babayeva, Gülüstan, Lerang, Frode, Leja, Mārcis, Kupčinskas, Juozas, Rokkas, Theodore, Marcos‐Pinto, Ricardo, Meštrović, Antonio, Gridnyev, Oleksiy, Phull, Perminder S., Smith, Sinead M., Boltin, Doron, Buzás, György Miklós, Kral, Jan, Şimşek, Halis, Matysiak‐Budnik, Tamara, Milivojevic, Vladimir, Marlicz, Wojciech, Venerito, Marino, Boyanova, Lyudmila, Doulberis, Michael, Capelle, Lisette G., Cano‐Català, Anna, Moreira, Leticia, Nyssen, Olga P., Mégraud, Francis, O’Morain, Colm, and Gisbert, Javier P.
Abstract: Adherence to Helicobacter pylori (H. pylori)eradication treatment is a cornerstone for achieving adequate treatment efficacy. To determine which factors influence compliance with treatment. A systematic prospective non‐interventional registry (Hp‐EuReg) of the clinical practice of European gastroenterologists. Compliance was considered adequate if ≥90% drug intake. Data were collected until September 2021 using the AEG‐REDCap e‐CRF and were subjected to quality control. Modified intention‐to‐treat analyses were performed. Multivariate analysis carried out the factors associated with the effectiveness of treatment and compliance. Compliance was inadequate in 646 (1.7%) of 38,698 patients. The non‐compliance rate was higher in patients prescribed longer regimens (10‐, 14‐days) and rescue treatments, patients with uninvestigated dyspepsia/functional dyspepsia, and patients reporting adverse effects. Prevalence of non‐adherence was lower for first‐line treatment than for rescue treatment (1.5% vs. 2.2%; p< 0.001). Differences in non‐adherence in the three most frequent first‐line treatments were shown: 1.1% with proton pump inhibitor + clarithromycin + amoxicillin; 2.3% with proton pump inhibitor clarithromycin amoxicillin metronidazole; and 1.8% with bismuth quadruple therapy. These treatments were significantly more effective in compliant than in non‐compliant patients: 86% versus 44%, 90% versus 71%, and 93% versus 64%, respectively (p< 0.001). In the multivariate analysis, the variable most significantly associated with higher effectiveness was adequate compliance (odds ratio, 6.3 [95%CI, 5.2–7.7]; p< 0.001). Compliance with Helicobacter pylorieradication treatment is very good. Factors associated with poor compliance include uninvestigated/functional dyspepsia, rescue‐treatment, prolonged treatment regimens, the presence of adverse events, and the use of non‐bismuth sequential and concomitant treatment. Adequate treatment compliance was the variable most closely associated with successful eradication.
Published: 2024
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2. European Registry on Helicobacter pylori management (Hp-EuReg): patterns and trends in first-line empirical eradication prescription and outcomes of 5 years and 21 533 patients

Author: Nyssen OP, Bordin D, Tepes B, Pérez-Aisa Á, Vaira D, Caldas M, Bujanda L, Castro-Fernandez M, Lerang F, Leja M, Rodrigo L, Rokkas T, Kupcinskas L, Pérez- Lasala J, Jonaitis L, Shvets O, Gasbarrini A, Simsek H, Axon ATR, Buzás G, Machado JC, Niv Y, Boyanova L, Goldis A, Lamy V, Tonkic A, Przytulski K, Beglinger C, Venerito M, Bytzer P, Capelle L, Milosavljević T, Milivojevic V, Veijola L, Molina-Infante J, Vologzhanina L, Fadeenko G, Ariño I, Fiorini G, Garre A, Garrido J, F Pérez C, Puig I, Heluwaert F, Megraud F, O'Morain C, Gisbert JP, Romano M, Universidad Autónoma de Madrid (UAM), AS Loginov Moscow Clinical Scientific Center [Moscow, Russian Federation], A.I. Yevdokimov Moscow State University of Medicine and Dentistry [Moscow, Russian Federation], AM DC Rogaska [Rogaska Slatina, Slovenia], Red de Investigación en Servicios de Salud en Enfermedades Crónicas (REDISSEC), University of Bologna/Università di Bologna, Universidad del Pais Vasco / Euskal Herriko Unibertsitatea [Espagne] (UPV/EHU), Centro de Investigación Biomédica en Red en el Área temática de Enfermedades Hepáticas y Digestivas (CIBERehd), Liver Unit, Clínica Universitaria, CIBER-EHD, Østfold Hospital, University of Latvia (LU), Universidad de Oviedo [Oviedo], Henry Dunant Hospital [Athens, Greece], Lithuanian University of Health Sciences [Kaunas, Lithuania], Hospital Universitario HM Sanchinarro [Madrid, Spain], Università cattolica del Sacro Cuore = Catholic University of the Sacred Heart [Roma] (Unicatt), Faculty of Medicine [Hacettepe University], Hacettepe University = Hacettepe Üniversitesi, Leeds General Infirmary (LGI), Leeds Teaching Hospitals NHS Trust, Ferencváros Health Centre [Budapest, Hungary], Faculdade de Medicina da Universidade do Porto (FMUP), Universidade do Porto = University of Porto, Tel Aviv University (TAU), Medical University of Sofia [Bulgarie], Timisoara Hospital [Timisoara, Romania], Centre Hospitalier Universitaire de Charleroi, University of Split, Medical Centre for Postgraduate Education [Warsaw, Poland], University Hospital Basel [Basel], Otto-von-Guericke-Universität Magdeburg = Otto-von-Guericke University [Magdeburg] (OVGU), Copenhagen University Hospital, Meander Medical Center [Amersfoort, Netherlands], University of Belgrade [Belgrade], Herttoniemi Hospital [Helsinki, Finland], San Pedro de Alcantara Hospital [Cáceres, Espagne], Gastrocentr [Perm, Russian Federation], Digestive Ukrainian Academy of Medical Sciences [Kyiv, Ukraine], Hospital Clínico Universitario 'Lozano Blesa' [Zaragoza, Spain], Althaia Xarxa Assistencial Universitària de Manresa [Manresa, Spain], Universitat de Vic-Universitat Central de Catalunya [Manresa, Spain] (UVicUCC), Complejo Hospitalario Universitario de Santiago de Compostela [Saint-Jacques-de-Compostelle, Espagne] (CHUS), Centre Hospitalier Annecy-Genevois [Saint-Julien-en-Genevois], Physiopathologie du cancer du foie, Université Bordeaux Segalen - Bordeaux 2-Institut National de la Santé et de la Recherche Médicale (INSERM), Hôpital Pellegrin, CHU Bordeaux [Bordeaux]-Groupe hospitalier Pellegrin, Trinity College Dublin, Hp-EuReg Investigators: Jen Hinojosa, Inmaculada Santaella, Nuria Fernandez Moreno, Ilaria Maria Saracino, Horacio Alonso Galán, Almudena Durán, Jennifer Fernandez Pacheco, Miroslav Vujasinovic, Rinaldo Pellicano Molinette, Zdenko Kikec, Pedro-Luis Gonzalez Cordero, Maia Donday, Polona Lampic, Vid Leban, Aleksander Gruncic Krajnc, Natasa Brglez Jurecic, Galyna Dmytrivna Fadieienko, Lorena Lee, Irene V Barbado, Alfredo José Lucendo, Alfredo José Lucendo, Jesus Barrio RIo Hortega, Tatiana Alekseevna Ilchishina, Irina Voynovan, Luis Ignacio Fernández-Salazar, Jose María Huguet, Pilar Canelles, Aiman Silkanovna Sarsenbaeva, Ines Modolell Consorci, Pedro Almela, Marina Roldán Lafuente, Josep Maria Botargues, Miguel Areia, Luís Elvas, Susana Isabel Alves, Daniel Brito, Ana Teresa Cadime, Sandra Lúcia Madeira Saraiva, Charalampos Tzathas, Vassiliki Ntouli, Alicia C Marin, Cem Simsek, Alba Rocco, Juan Antonio Ortuño, Tommaso Di Maira, Sotirios D Georgopoulos, Stephan Brackmann, Vendel Kristensen Lovisenberg, Blas Jose Gomez-Rodriguez, Perminder Singh Phull, Sergey Alekseyevich, Monica Perona, Rustam Abdulkhakov, Deirdre McNamara, Sinead M Smith, Denise Elizabeth Brennan, Marina Fedorovna Osipenko, Cristobal de la Coba, Pilar Varela, Maria Anatolyevna Livzan, Oleg V Zaytsev, Vladislav Vladimirovich Tsukanov, Alexander Viktorovich Vasyutin, Olga Sergeevna Amelchugova, Spiros Michopoulus, Sergey Gennadievich Burkov, Dan Dumitrascu, Bogdan Ianosi, Ingrid Prytz Berset, Rafael Ruiz-Zorrilla Lopez, Charo Antón, Anne Courillon-Mallet, Natasa Brglez Jurecic, Judith Gomez-Camarero, Manuel Jimenez-Moreno, Ahmet Uygun, Ian Leonard Phillip Beales, Alain Huerta-Madrigal, Javier Alcedo, Mercè Barenys, Francesco Franceschi, Jean-Charles Delchier, Liliana Silvia Pozzati, Monika Augustyn, Maja Seruga, Miriam Hiestand, Patric Mosler, Zaza Beniashvili, Doron Boltin, Hubert Louis, Ramon Pajares, Natalia Valerievna Zakharova, Natalia Nikolaevna Dekhnich, Victor Asparuhov Kamburov, Maria Pina Dore, Lorena Sancho, Oscar Núñez, Katrine Dvergsnes Sørlandet, Peter Malfertheiner, Ana Campillo, Miguel Fernandez-Bermejo, Manuel Domínguez-Cajal, José Luis Domínguez Jiménez, Alicia Algaba, Fernando Bermejo, Borislav Vladimirov, László Czakó, Teresa Angueira, Eduardo Iyo, Ekaterina Yuryevna, Larissa Tarasova, Ludmila Grigorieva, Judith Millastre, Aldis Pukitis, Valeriy Kryvy, Roald Torp, Albert Tomàs, Edurne Amorena, Fermin Estremera, Rossen Nikolov, Asghar Quasim, Yury Aleksandrovich Kucheryavyy, Natalia Baryshnikova, Xavier Calvet, Ariadna Figuerola, Marco Romano, Antonietta Gerarda Gravina, Oscar Núñez, Fazia Mana, Pilar Sánchez-Pobre, Zoya Spassova, Jesús M González-Santiago, Ricardo Marcos-Pinto, F Wolfhagen, Svetlana Cui, Ivonne Leeuwenburgh, Driffa Moussata, Adi Lahat-Zok, Sergii Hryhorovych, Rasmus Goll, Tatyana Vasilyevna, Juris Pokrotnieks, Philippe Émile, Nadiya Byelyayeva, Marta Lozano, Mette Wildner-Christensen, Bengt Odman, Yana Valerieva, Alenka Forte, Antonio Cuadrado, Patrice Pienkowski, Ilze Kikuste, Dag Arne Lihaug Hoff, Jane Moeller Hansen, Konrads Funka, Alla Kononova, Sergey Kolbasnikov, Michael Selgrad, Jolanta Sumskiene, Jonathan Hirsch, Francisco Javier Zozaya Larequi, Alain C Burette, Nora Dancs Petz-Aladar, Janne Rajala Herttoniemi, Christina Reimer, Diogo Libanio, Pedro Pimentel-Nunes, Ivailo Evstatiev, Juozas Kupcinskas, Mikhail Butov, Peter Mensink, T Tang, Andrey Yurevich Baranovsky, Natalya Marchenko, Boris Bastens, Lyudmila Mateva, Dominique Lamarque, Leonardo Henry, Mario Ribeiro, M Ter Borg, Alexander C Ford, Enrique Medina, Manuel Rodriguez-Tellez, Francisco José Rancel, Elisa Martin, Carolina Torres Gonzalez, Lissa Maria Franco, Angel Lanas, Pilar Canelles, Noelia Alcaide, Bruno Richard-Molard, Megraud, Francis, Nyssen O.P., Bordin D., Tepes B., Perez-Aisa A., Vaira D., Caldas M., Bujanda L., Castro-Fernandez M., Lerang F., Leja M., Rodrigo L., Rokkas T., Kupcinskas L., Perez-Lasala J., Jonaitis L., Shvets O., Gasbarrini A., Simsek H., Axon A.T.R., Buzas G., Machado J.C., Niv Y., Boyanova L., Goldis A., Lamy V., Tonkic A., Przytulski K., Beglinger C., Venerito M., Bytzer P., Capelle L., Milosavljevic T., Milivojevic V., Veijola L., Molina-Infante J., Vologzhanina L., Fadeenko G., Arino I., Fiorini G., Garre A., Garrido J., F Perez C., Puig I., Heluwaert F., Megraud F., O'Morain C., Gisbert J.P., Universidad Autonoma de Madrid (UAM), University of Bologna, Università cattolica del Sacro Cuore [Roma] (Unicatt), Universidade do Porto, Tel Aviv University [Tel Aviv], Otto-von-Guericke University [Magdeburg] (OVGU), Nyssen, Op, Bordin, D, Tepes, B, Pérez-Aisa, Á, Vaira, D, Caldas, M, Bujanda, L, Castro-Fernandez, M, Lerang, F, Leja, M, Rodrigo, L, Rokkas, T, Kupcinskas, L, Pérez- Lasala, J, Jonaitis, L, Shvets, O, Gasbarrini, A, Simsek, H, Axon, Atr, Buzás, G, Machado, Jc, Niv, Y, Boyanova, L, Goldis, A, Lamy, V, Tonkic, A, Przytulski, K, Beglinger, C, Venerito, M, Bytzer, P, Capelle, L, Milosavljević, T, Milivojevic, V, Veijola, L, Molina-Infante, J, Vologzhanina, L, Fadeenko, G, Ariño, I, Fiorini, G, Garre, A, Garrido, J, F Pérez, C, Puig, I, Heluwaert, F, Megraud, F, O'Morain, C, Gisbert, Jp, and Romano, M
Subjects: Male, Registrie, Proton Pump Inhibitor, Practice Patterns, 0302 clinical medicine, Clarithromycin, Prospective Studies, Registries, Practice Patterns, Physicians', [SDV.MHEP] Life Sciences [q-bio]/Human health and pathology, biology, Gastroenterology, Middle Aged, Anti-Bacterial Agents, 3. Good health, Europe, 030220 oncology & carcinogenesis, Combination, 030211 gastroenterology & hepatology, Drug Therapy, Combination, Female, medicine.drug, Human, Adult, medicine.medical_specialty, TRIPLE THERAPY, QUADRUPLE THERAPY, CONSENSUS, INFECTION, METAANALYSIS, CLARITHROMYCIN, GUIDELINES, RESISTANCE, ARTICLE, Settore MED/12 - GASTROENTEROLOGIA, First line, Helicobacter Infections, 03 medical and health sciences, Drug Therapy, Internal medicine, Anti-Bacterial Agent, medicine, Humans, Medical prescription, Adverse effect, Aged, Physicians', Helicobacter pylori, business.industry, helicobacter pylori - treatment, Proton Pump Inhibitors, Amoxicillin, biology.organism_classification, Metronidazole, Prospective Studie, Concomitant, helicobacter pylori, business, Helicobacter Infection, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology
Abstract: ObjectiveThe best approach for Helicobacter pylori management remains unclear. An audit process is essential to ensure clinical practice is aligned with best standards of care.DesignInternational multicentre prospective non-interventional registry starting in 2013 aimed to evaluate the decisions and outcomes in H. pylori management by European gastroenterologists. Patients were registered in an e-CRF by AEG-REDCap. Variables included demographics, previous eradication attempts, prescribed treatment, adverse events and outcomes. Data monitoring was performed to ensure data quality. Time-trend and geographical analyses were performed.Results30 394 patients from 27 European countries were evaluated and 21 533 (78%) first-line empirical H. pylori treatments were included for analysis. Pretreatment resistance rates were 23% to clarithromycin, 32% to metronidazole and 13% to both. Triple therapy with amoxicillin and clarithromycin was most commonly prescribed (39%), achieving 81.5% modified intention-to-treat eradication rate. Over 90% eradication was obtained only with 10-day bismuth quadruple or 14-day concomitant treatments. Longer treatment duration, higher acid inhibition and compliance were associated with higher eradication rates. Time-trend analysis showed a region-dependent shift in prescriptions including abandoning triple therapies, using higher acid-inhibition and longer treatments, which was associated with an overall effectiveness increase (84%–90%).ConclusionManagement of H. pylori infection by European gastroenterologists is heterogeneous, suboptimal and discrepant with current recommendations. Only quadruple therapies lasting at least 10 days are able to achieve over 90% eradication rates. European recommendations are being slowly and heterogeneously incorporated into routine clinical practice, which was associated with a corresponding increase in effectiveness.
Published: 2020
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3. Room for Improvement in the Treatment of Helicobacter pylori Infection: Lessons from the European Registry on H. pylori Management (Hp-EuReg)

Author: Nyssen, O. P., Vaira, D., Tepes, B., Kupcinskas, L., Bordin, D., Perez-Aisa, A., Gasbarrini, Antonio, Castro-Fernandez, M., Bujanda, L., Garre, A., Lucendo, A., Vologzhanina, L., Jurecic, N. B., Rodrigo-Saez, L., Huguet, J. M., Voynovan, I., Perez-Lasala, J., Romero, P. M., Vujasinovic, M., Abdulkhakov, R., Barrio, J., Fernandez-Salazar, L., Megraud, F., O'Morain, C., Gisbert, J. P., Gasbarrini A. (ORCID:0000-0002-7278-4823), Nyssen, O. P., Vaira, D., Tepes, B., Kupcinskas, L., Bordin, D., Perez-Aisa, A., Gasbarrini, Antonio, Castro-Fernandez, M., Bujanda, L., Garre, A., Lucendo, A., Vologzhanina, L., Jurecic, N. B., Rodrigo-Saez, L., Huguet, J. M., Voynovan, I., Perez-Lasala, J., Romero, P. M., Vujasinovic, M., Abdulkhakov, R., Barrio, J., Fernandez-Salazar, L., Megraud, F., O'Morain, C., Gisbert, J. P., and Gasbarrini A. (ORCID:0000-0002-7278-4823)
Abstract: Background: Managing Helicobacter pylori infection requires constant decision making, and each decision is open to possible errors. Aim: The aim was to evaluate common mistakes in the eradication of H. pylori, based on the "European Registry on Helicobacter pylori management". Methods: European Registry on Helicobacter pylori management is an international multicentre prospective noninterventional registry evaluating the decisions and outcomes of H. pylori management by European gastroenterologists in routine clinical practice. Results: Countries recruiting more than 1000 patients were included (26,340 patients). The most common mistakes (percentages) were: (1) To use the standard triple therapy where it is ineffective (46%). (2) To prescribe eradication therapy for only 7 to 10 days (69%). (3) To use a low dose of proton pump inhibitors (48%). (4) In patients allergic to penicillin, to prescribe always a triple therapy with clarithromycin and metronidazole (38%). (5) To repeat certain antibiotics after eradication failure (>15%). (6) Failing to consider the importance of compliance with treatment (2%). (7) Not to check the eradication success (6%). Time-trend analyses showed progressive greater compliance with current clinical guidelines. Conclusion: The management of H. pylori infection by some European gastroenterologists is heterogeneous, frequently suboptimal and discrepant with current recommendations. Clinical practice is constantly adapting to updated recommendations, although this shift is delayed and slow.
Published: 2022

4. P792 Modulation of the fecal metagenome in patients with Crohnʼs disease

Author: Rojas-Feria, M., Fernández Caballero-Rico, J.A., Pastor Ramírez, H., Castro-Fernandez, M., Chueca Porcuna, N., Grande Santamaría, L., Romero-Gmez, M., García, F., and Del Campo, J.A.
Published: 2017
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5. Empirical Second-Line Therapy in 5,000 Patients of the European Registry on Helicobacter pylori Management (Hp-EuReg)

Author: Nyssen OP, Vaira D, Pérez Aísa Á, Rodrigo L, Castro-Fernandez M, Jonaitis L, Tepes B, Vologzhanina L, Caldas M, Lanas A, Lucendo AJ, Bujanda L, Ortuño J, Barrio J, Huguet JM, Voynovan I, Lasala JP, Sarsenbaeva AS, Fernandez-Salazar L, Molina-Infante J, Jurecic NB, Areia M, Gasbarrini A, Kupcinskas J, Bordin D, Marcos-Pinto R, Lerand F, Leja M, Buzas GM, Niv Y, Rokkas T, Phull P, Smith S, Shvets O, Venerito M, Milivojevic V, Simsek I, Lamy V, Bytzer P, Boyanova L, Kunovský L, Beglinger C, Doulberis M, Marlicz W, Goldis A, Tonkic A, Capelle L, Puig I, Megraud F, Morain CO, Gisbert JP, and European Registry on Helicobacter pylori Management Hp-EuReg Investigators
Subjects: Helicobacter pylori, Clarithromycin, Rescue, Levofloxacin, Bismuth
Abstract: BACKGROUND & AIMS: After a first Helicobacter pylori eradication attempt, approximately 20% of patients will remain infected. The aim of the current study was to assess the effectiveness and safety of second-line empiric treatment in Europe. METHODS: This international, multicenter, prospective, noninterventional registry aimed to evaluate the decisions and outcomes of H pylori management by European gastroenterologists. All infected adult cases with a previous eradication treatment attempt were registered with the Spanish Association of Gastroenterology-Research Electronic Data Capture until February 2021. Patients allergic to penicillin and those who received susceptibility-guided therapy were excluded. Data monitoring was performed to ensure data quality. RESULTS: Overall, 5055 patients received empiric second-line treatment. Triple therapy with amoxicillin and levofloxacin was prescribed most commonly (33%). The overall effectiveness was 82% by modified intention-to-treat analysis and 83% in the per-protocol population. After failure of first-line clarithromycin-containing treatment, optimal eradication (>90%) was obtained with moxifloxacin-containing triple therapy or levofloxacin-containing quadruple therapy (with bismuth). In patients receiving triple therapy containing levofloxacin or moxifloxacin, and levofloxacin-bismuth quadruple treatment, cure rates were optimized with 14-day regimens using high doses of proton pump inhibitors. However, 3-in-1 single capsule or levofloxacin-bismuth quadruple therapy produced reliable eradication rates regardless of proton pump inhibitor dose, duration of therapy, or previous first-line treatment. The overall incidence of adverse events was 28%, and most (85%) were mild. Three patients developed serious adverse events (0.3%) requiring hospitalization. CONCLUSIONS: Empiric second-line regimens including 14-day quinolone triple therapies, 14-day levofloxacin-bismuth quadruple therapy, 14-day tetracycline-bismuth classic quadruple therapy, and 10-day bismuth quadruple therapy (as a single capsule) provided optimal effectiveness. However, many other second-line treatments evaluated reported low eradication rates. ClincialTrials.gov number: NCT02328131.
Published: 2022

6. Role of the proton pump inhibitors in Helicobacter pylori eradication: results from the European registry on H. pylori management (HP-EUREG)

Author: M. Castro Fernandez, M. Pabón-Carrasco, A. Keco- Huerga1, Á. Pérez-Aísa, D. Vaira, L. Jonaitis, B. Tepes, D. Bordin, A. Lucendo, L. Vologzhanina, L. Bujanda, N. Brglez Jurecic, A. Lanas, M. Leja, E. Mammadov, U. Mahmudov, M. Caldas, L. Rodrigo, F. Lerang, G. Fadieienko, R. Abdulkhakov, J.M. Huguet Malavés, O. Zaytsev, T. Ilchishina, L. Fernández- Salazar, A. Silkanovna Sarsenbaeva, I. Bakulin, A.G. Gravina, M. Perona, S. Alekseenko, J. Barrio, M. Areia, Ó. Nuñez, P. Bogomolov, B.J. Gomez Rodriguez, M. Dominguez-Cajal, J. Gomez Camarero, S. Georgopoulos, P. Almela Notari, Ante Tonkić, R. Pellicano, H. Simsek, L. Kunovský, A. Gasbarrini, J.M. Botargues Bote, I. Puig, O. Perez Nyssen, F. Mégraud, C. O’Morain, J. P. Gisbert
Subjects: Helicobacter pylori, proton pump inhibitors
Abstract: Introduction: Management of Helicobacter pylori infection (H. pylori) re-quires co- treatment with proton pump inhibitors (PPIs) and the use of an- tibiotics to achieve successful eradicationAims & Methods: To evaluate the role of PPIs in the eradication of H. py-lori, based on the “European Registry onHelicobacter pylori Management” (Hp- EuReg).The Hp-EuReg is a multicentre, prospective, non-interventional, registry assessing decisions and outcomes of H. pylori management by European gastroenterologists in routine clinical practice. Countries recruiting more than 1, 000 patients were included. Effectiveness was assessed by modi- fied intention-to-treat (mITT). Data were quality reviewed.Results: Overall, 22, 078 patients from 5 countries were analysed. Optimal (»90%) first-line mITT effectiveness was achieved with the following treatments: 14-day clarithromycin- amoxicillin- bismuth quadruple therapy, and 14- day metronidazole-tetracycline-bismuth quadruple therapy, both inde-pendently of the PPI dose prescribed ; in all 10- or 14-day therapies with high-dose PPIs (except with standard 10-day triple therapy) ; in 10-day se-quential and 10- day quadruple clarithromycin-amoxicillin- bismuth, and 10-day quadruple metronidazole- tetracycline- bismuth with standard-dose PPIs. None of the 7-day therapies achieved optimal cure rates re-gardless of the PPI dose used. The PPI dose was significantly associated with the effectiveness of: 10- or 14- day standard triple and quadruple con-comitant therapies, and 10-day quadruple sequential and metronidazole-tetracycline-bismuth therapies. Table 1 details the mITT effectiveness by duration and PPI dose used.Conclusion: In first-lineH. pylori treatment, ≥90% effectiveness is obtained with standard-dose PPIs in 10-day sequential and 10- or 14-day bismuth quadruple therapies and with high-dose PPIs in all 10- or 14-day therapies except with standard 10-day triple therapy.
Published: 2022

7. Room for Improvement in the Treatment of Helicobacter pylori Infection: Lessons from the European Registry on H. pylori Management (Hp-EuReg)

Author: Nyssen O. P., Vaira D., Tepes B., Kupcinskas L., Bordin D., Perez-Aisa A., Gasbarrini A., Castro-Fernandez M., Bujanda L., Garre A., Lucendo A. J., Vologzhanina L., Jurecic N. B., Rodrigo-Saez L., Huguet J. M., Voynovan I., Perez-Lasala J., Romero P. M., Vujasinovic M., Abdulkhakov R., Barrio J., Fernandez-Salazar L., Megraud F., O'Morain C., Gisbert J. P., Ilchishina T., Arino I., Zaytsev O., Perona M., Sarsenbaeva A. S., Ortuno J., Alekseenko S., Dominguez-Cajal M., Rodriguez B. J. G., Notari P. A., Pellicano R., Consorci I. M., Nardone G., Bote J. M. B. -A., Nunez O., Gomez-Camarero J., Guadix J. H., Fiorini G., Jonaitis L., Galan H. A., Ferrer L., Molina-Infante J., Kikec Z., Alcaide N., Lanas A., Sant'Orsola V. C., Medina-Chulia E., Canelles P., Santos-Fernandez J., Velayos B., Di Maira T., Lafuente M. R., Moreno M. J., Dekhnich N. N., Varela P., de la Coba C., Osipenko M. F., Lopez R. R. -Z., Huerta-Madrigal A., Livzan M. A., Pozzati L. S., Iyo E., Amelchugova O. S., Vasyutin A. V., Tsukanov V. V., Barenys M., Burkov S. G., Gravina A. G., Romano M., Bakulina N. V., Fernandez-Bermejo M., Alcedo J., Franceschi F., Campillo A., Seruga M., Villarroya R. P., Mego M., Dore M. P., Tito L., Gmez B., Jimenez J. L. D., Bermejo F., Algaba A., Belousova L. N., Plotnikova E. Y., Calvet X., Figuerola A., Tarasova L., Grigorieva L., Amorena E., Estremera F., Sanchez-Pobre P., Millastre J., Tomas A., Baryshnikova N., Kucheryavyy Y. A., Kononova A., Bakulin I., Cerezo F. J. M., Venciene R., Zhestkova T. V., Rocco A., Gonzalez Santiago J. M., Nyssen, O. P., Vaira, D., Tepes, B., Kupcinskas, L., Bordin, D., Perez-Aisa, A., Gasbarrini, A., Castro-Fernandez, M., Bujanda, L., Garre, A., Lucendo, A. J., Vologzhanina, L., Jurecic, N. B., Rodrigo-Saez, L., Huguet, J. M., Voynovan, I., Perez-Lasala, J., Romero, P. M., Vujasinovic, M., Abdulkhakov, R., Barrio, J., Fernandez-Salazar, L., Megraud, F., O'Morain, C., Gisbert, J. P., Ilchishina, T., Arino, I., Zaytsev, O., Perona, M., Sarsenbaeva, A. S., Ortuno, J., Alekseenko, S., Dominguez-Cajal, M., Rodriguez, B. J. G., Notari, P. A., Pellicano, R., Consorci, I. M., Nardone, G., Bote, J. M. B. -A., Nunez, O., Gomez-Camarero, J., Guadix, J. H., Fiorini, G., Jonaitis, L., Galan, H. A., Ferrer, L., Molina-Infante, J., Kikec, Z., Alcaide, N., Lanas, A., Sant'Orsola, V. C., Medina-Chulia, E., Canelles, P., Santos-Fernandez, J., Velayos, B., Di Maira, T., Lafuente, M. R., Moreno, M. J., Dekhnich, N. N., Varela, P., de la Coba, C., Osipenko, M. F., Lopez, R. R. -Z., Huerta-Madrigal, A., Livzan, M. A., Pozzati, L. S., Iyo, E., Amelchugova, O. S., Vasyutin, A. V., Tsukanov, V. V., Barenys, M., Burkov, S. G., Gravina, A. G., Romano, M., Bakulina, N. V., Fernandez-Bermejo, M., Alcedo, J., Franceschi, F., Campillo, A., Seruga, M., Villarroya, R. P., Mego, M., Dore, M. P., Tito, L., Gmez, B., Jimenez, J. L. D., Bermejo, F., Algaba, A., Belousova, L. N., Plotnikova, E. Y., Calvet, X., Figuerola, A., Tarasova, L., Grigorieva, L., Amorena, E., Estremera, F., Sanchez-Pobre, P., Millastre, J., Tomas, A., Baryshnikova, N., Kucheryavyy, Y. A., Kononova, A., Bakulin, I., Cerezo, F. J. M., Venciene, R., Zhestkova, T. V., Rocco, A., Gonzalez Santiago, J. M., Lucendo, A., and the Hp-EuReg, Investigator
Subjects: Registrie, medicine.medical_specialty, Proton Pump Inhibitor, medicine.drug_class, Settore MED/12 - GASTROENTEROLOGIA, Antibiotics, MEDLINE, Helicobacter Infections, 03 medical and health sciences, 0302 clinical medicine, Pharmacotherapy, Drug Therapy, Clarithromycin, Internal medicine, Metronidazole, Anti-Bacterial Agent, bismuth, medicine, non-bismuth, Humans, Prospective Studies, Registries, Disease management (health), levofloxacin, biology, Helicobacter pylori, business.industry, mistake, Gastroenterology, Amoxicillin, Proton Pump Inhibitors, biology.organism_classification, error, Anti-Bacterial Agents, Penicillin, Prospective Studie, 030220 oncology & carcinogenesis, Combination, 030211 gastroenterology & hepatology, Drug Therapy, Combination, business, Helicobacter Infection, H. pylori, medicine.drug, Human
Abstract: BACKGROUND: Managing Helicobacter pylori infection requires constant decision making, and each decision is open to possible errors. AIM: The aim was to evaluate common mistakes in the eradication of H. pylori, based on the "European Registry on Helicobacter pylori management". METHODS: European Registry on Helicobacter pylori management is an international multicentre prospective noninterventional registry evaluating the decisions and outcomes of H. pylori management by European gastroenterologists in routine clinical practice. RESULTS: Countries recruiting more than 1000 patients were included (26,340 patients). The most common mistakes (percentages) were: (1) To use the standard triple therapy where it is ineffective (46%). (2) To prescribe eradication therapy for only 7 to 10 days (69%). (3) To use a low dose of proton pump inhibitors (48%). (4) In patients allergic to penicillin, to prescribe always a triple therapy with clarithromycin and metronidazole (38%). (5) To repeat certain antibiotics after eradication failure (>15%). (6) Failing to consider the importance of compliance with treatment (2%). (7) Not to check the eradication success (6%). Time-trend analyses showed progressive greater compliance with current clinical guidelines. CONCLUSION: The management of H. pylori infection by some European gastroenterologists is heterogeneous, frequently suboptimal and discrepant with current recommendations. Clinical practice is constantly adapting to updated recommendations, although this shift is delayed and slow.
Published: 2020

8. European Registry on Helicobacter pylori management (Hp-EuReg): Patterns and trends in first-line empirical eradication prescription and outcomes of 5 years and 21 533 patients

Author: Nyssen, O. P., Bordin, D., Tepes, B., Perez-Aisa, A., Vaira, D., Caldas, M., Bujanda, L., Castro-Fernandez, M., Lerang, F., Leja, M., Rodrigo, L., Rokkas, T., Kupcinskas, L., Perez-Lasala, J., Jonaitis, L., Shvets, O., Gasbarrini, Antonio, Simsek, H., Axon, A. T. R., Buzas, G., Machado, J. C., Niv, Y., Boyanova, L., Goldis, A., Lamy, V., Tonkic, A., Przytulski, K., Beglinger, C., Venerito, M., Bytzer, P., Capelle, L., Milosavljevic, T., Milivojevic, V., Veijola, L., Molina-Infante, J., Vologzhanina, L., Fadeenko, G., Arino, I., Fiorini, G., Garre, A., Garrido, J., F Perez, C., Puig, I., Heluwaert, F., Megraud, F., O'Morain, C., Gisbert, J. P., Gasbarrini A. (ORCID:0000-0002-7278-4823), Nyssen, O. P., Bordin, D., Tepes, B., Perez-Aisa, A., Vaira, D., Caldas, M., Bujanda, L., Castro-Fernandez, M., Lerang, F., Leja, M., Rodrigo, L., Rokkas, T., Kupcinskas, L., Perez-Lasala, J., Jonaitis, L., Shvets, O., Gasbarrini, Antonio, Simsek, H., Axon, A. T. R., Buzas, G., Machado, J. C., Niv, Y., Boyanova, L., Goldis, A., Lamy, V., Tonkic, A., Przytulski, K., Beglinger, C., Venerito, M., Bytzer, P., Capelle, L., Milosavljevic, T., Milivojevic, V., Veijola, L., Molina-Infante, J., Vologzhanina, L., Fadeenko, G., Arino, I., Fiorini, G., Garre, A., Garrido, J., F Perez, C., Puig, I., Heluwaert, F., Megraud, F., O'Morain, C., Gisbert, J. P., and Gasbarrini A. (ORCID:0000-0002-7278-4823)
Abstract: Objective The best approach for Helicobacter pylori management remains unclear. An audit process is essential to ensure clinical practice is aligned with best standards of care. Design International multicentre prospective non-interventional registry starting in 2013 aimed to evaluate the decisions and outcomes in H. pylori management by European gastroenterologists. Patients were registered in an e-CRF by AEG-REDCap. Variables included demographics, previous eradication attempts, prescribed treatment, adverse events and outcomes. Data monitoring was performed to ensure data quality. Time-trend and geographical analyses were performed. Results 30 394 patients from 27 European countries were evaluated and 21 533 (78%) first-line empirical H. pylori treatments were included for analysis. Pretreatment resistance rates were 23% to clarithromycin, 32% to metronidazole and 13% to both. Triple therapy with amoxicillin and clarithromycin was most commonly prescribed (39%), achieving 81.5% modified intention-to-treat eradication rate. Over 90% eradication was obtained only with 10-day bismuth quadruple or 14-day concomitant treatments. Longer treatment duration, higher acid inhibition and compliance were associated with higher eradication rates. Time-trend analysis showed a region-dependent shift in prescriptions including abandoning triple therapies, using higher acid-inhibition and longer treatments, which was associated with an overall effectiveness increase (84%-90%). Conclusion Management of H. pylori infection by European gastroenterologists is heterogeneous, suboptimal and discrepant with current recommendations. Only quadruple therapies lasting at least 10 days are able to achieve over 90% eradication rates. European recommendations are being slowly and heterogeneously incorporated into routine clinical practice, which was associated with a corresponding increase in effectiveness.
Published: 2021

9. European Registry on Helicobacter pylori management: Single-capsule bismuth quadruple therapy is effective in real-world clinical practice

Author: Nyssen, O. P., Perez-Aisa, A., Castro-Fernandez, M., Pellicano, R., Huguet, J. M., Rodrigo, L., Ortun, J., O, Gomez-Rodriguez, B. J., Pinto, R. M., Areia, M., Perona, M., Nunez, O., Romano, M., Gravina, A. G., Pozzati, L., Fernandez-Bermejo, M., Venerito, M., Malfertheiner, P., Fernanadez-Salazar, L., Gasbarrini, Antonio, Vaira, D., Puig, I., Megraud, F., O'Morain, C., Gisbert, J. P., Gasbarrini A. (ORCID:0000-0002-7278-4823), Nyssen, O. P., Perez-Aisa, A., Castro-Fernandez, M., Pellicano, R., Huguet, J. M., Rodrigo, L., Ortun, J., O, Gomez-Rodriguez, B. J., Pinto, R. M., Areia, M., Perona, M., Nunez, O., Romano, M., Gravina, A. G., Pozzati, L., Fernandez-Bermejo, M., Venerito, M., Malfertheiner, P., Fernanadez-Salazar, L., Gasbarrini, Antonio, Vaira, D., Puig, I., Megraud, F., O'Morain, C., Gisbert, J. P., and Gasbarrini A. (ORCID:0000-0002-7278-4823)
Abstract: Background: There has been resurgence in the use of bismuth quadruple therapy (proton pump inhibitor, bismuth, tetracycline and metronidazole) for treating Helicobacter pylori infection thanks to a three-in-one single-capsule formulation. Objective: To evaluate the effectiveness and safety of the single-capsule bismuth quadruple therapy. Methods: Data were collected in a multicentre, prospective registry of the clinical practice of gastroenterologists on the management of H. pylori infection, where patients were registered at the Asociación Española de Gastroenterologia REDCap database on an electronic case report form until January 2020. Effectiveness by modified intention-to-treat and per-protocol as well as multivariable analysis were performed. Independent factors evaluated were: age, gender, indication, compliance, proton pump inhibitor dose and treatment line. Results: Finally, 2100 patients were prescribed single-capsule bismuth quadruple therapy following the technical sheet (i.e., three capsules every 6 h for 10 days). The majority of these patients were naive (64%), with an average age of 50 years, 64% women and 16% with peptic ulcer. An overall modified intention-to-treat effectiveness of 92% was achieved. Eradication was over 90% in first-line treatment (95% modified intention-to-treat, n = 1166), and this was maintained as a rescue therapy, both in second (89% modified intention-to-treat, n = 375) and subsequent lines of therapy (third to sixth line: 92% modified intention-to-treat, n = 236). Compliance was the factor most closely associated with treatment effectiveness. Adverse events were generally mild to moderate, and 3% of patients reported a severe adverse event, leading to discontinuation of treatment in 1.7% of cases. Conclusions: Single-capsule bismuth quadruple therapy achieved H. pylori eradication in approximately 90% of patients in real-world clinical practice, both as a first-line and rescue treatment, with good compliance and a favourab
Published: 2021

10. P328 Ustekinumab is an effective and safe therapy in anti-TNF refractory Crohn’s Disease: a two year real-life observational study from Spain

Author: Rueda Sanchez, J, primary, Cabello Ramirez, M, additional, Camara Baena, S, additional, Keco Huerga, A, additional, Garcia de la Borbolla Serres, J, additional, Castro Fernandez, M, additional, and Grande Santamaria, L, additional
Published: 2021
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11. Impact of Helicobacter pylori clarithromycin resistance on the treatment effectiveness: data of the European registry on H. pylori management (HP- EUREG)

Author: Bujanda L., Nyssen O.P., Cosme A., Bordin D.S., Tepeš B., Pere-Aisa A., Vaira D., Caldas Álvarez M., Castro-Fernandez M., Lerang F., Leja M., Rodrigo L., Rokkas T., Kupcinskas L., Perez-Lasala J., Jonaitis L., Shvets O., Gasbarrini A., Simsek H., Axon A.T.R., Buzas G.M., Machado J.C., Niv Y., Boyanova L., Goldis A., Lamy V., Tonkić Ante, Marlicz W., Beglinger C., Venerito M., Bytzer P., Capelle L.G., Milosavljevic T., Veijola L.I., Molina Infante J., Vologhzanina L., Fadeenko G., Ariño I., Fiorini G., Resina E., Muñoz R., Puig I., Megraud F., O’ Morain C., Gisbert J.P.
Subjects: Helicobacter pylori, clarithromycin, resistance
Abstract: Introduction: Antibiotic resistance is the major factor affecting our ability to cure Helicobacter pylori infection. Quadruple therapy is currently recommended ; however, triple therapy with two antibiotics may be sufficient in those patients without clarithromycin resistance. Aims & Methods: To evaluate the effectiveness of the treatments according to the clarithromycin H. pylori resistance in Europe. International multicenter prospective non-interventional European Registry on H. pylori Management (Hp-EuReg) aiming to evaluate the decisions and outcomes of H. pylori infection. Infected adult patients diagnosed with culture registered at AEG-REDCap e- CRF from 2013 to 2019. Per-protocol (PP) analysis was performed based on the presence or absence of clarithromycin bacterial resistance. Results: Overall, 5, 036 patients were included: 1, 747 (35%) were resistant and 3, 289 (65%) sensitive to clarithromycin. The overall eradication rate was higher in clarithromycin-susceptible patients (91% vs. 84% ; p< 0.001). Triple therapy with a PPI, clarithromycin and amoxicillin achieved over 90% eradication rates in clarithromycin- susceptible patients. However, in those with clarithromycin- resistance, optimal effectiveness was only achieved when treated with quadruple therapy with a PPI, clarithromycin, amoxicillin and bismuth. Conclusion: Classic triple therapy with a PPI, clarithromycin and amoxicillin achieves optimal results (>90%) in patients susceptible to clarithromycin. However, when clarithromycin resistance is unknown, quadruple therapy with a PPI, clarithromycin, amoxicillin and bismuth may be a better treatment option.
Published: 2020

12. Helicobacter pylori antibiotic resistance: data from the European registry on H. pylori management (HP-EUREG)

Author: Bujanda L., Nyssen O.P., Cosme A., Bordin D.S., Tepeš B., Pere-Aisa A., Vaira D., Caldas Álvarez M., Castro-Fernandez M., Lerang F., Leja M., Rodrigo L., Rokkas T., Kupcinskas L., Perez-Lasala J., Jonaitis L., Shvets O., Gasbarrini A., Simsek H., Axon A.T.R., Buzas G.M., Machado J.C., Niv Y., Boyanova L., Goldis A., Lamy V., Tonkić Ante, Marlicz W., Beglinger C., Venerito M., Bytzer P., Capelle L.G., Milosavljevic T., Veijola L.I., Molina Infante J., Vologhzanina L., Fadeenko G., Ariño I., Fiorini G., Resina E., Muñoz R., Puig I., Megraud F., O’ Morain C., Gisbert J.P.
Subjects: Helicobacter pylori, antibiotic resistance
Abstract: Introduction: Antibiotic resistance is the major factor affecting our ability to cure Helicobacter pylori infection. Understanding the different H. pylori antibiotic resistances could be the key to improve treatment effectiveness. Aims & Methods: To evaluate the H. pylori antibiotic resistance both prior and after one or several eradication treatments, in order to provide the most appropriate recommendations for the eradication of H. pylori. International multicenter prospective non-interventional European Regis-try on H. pylori Management (Hp- EuReg) aiming to evaluate the decisions and outcomes of H. pylori infection by European gastroenterologists. Infected adult patients diagnosed with culture and with a result of the antibiotic resistance test registered at AEG- REDCap e-CRF from 2013 to 2019. Per-protocol (PP) analysis was performed. The antibiotic bacterial resistances were described by treatment line. Results: A total of 32, 447 patients were included, and culture was performed in 3, 474 (11%). In naïve patients, 21% reported single clarithromycin resistance, and 11% dual (clarithromycin and metronidazole) resistance. Antibiotic resistance increased markedly from the first treatment, reaching over 37% dual resistance in second-line treatment. Conclusion: In Europe, culture testing to determine antibiotic resistance against H. pylori is scarce. H. pylori single clarithromycin resistance remains high (>15%) in all treatment lines, and greater than 20% in naïve patients. Dual or triple resistances are frequent and increase remarkably after the first treatment failure. Resistance to amoxicillin or tetracycline is exceptional.
Published: 2020

13. European Registry on Helicobacter pylori Management: single-capsule bismuth quadruple therapy is effective in real-world clinical practice

Author: Nyssen OP, Perez-Aisa A, Castro-Fernandez M, Pellicano R, Huguet JM, Rodrigo L, Ortuño J, Gomez-Rodriguez BJ, Pinto RM, Areia M, Perona M, Nuñez O, Romano M, Gerarda Gravina A, Pozzati L, Fernandez-Bermejo M, Venerito M, Malfertheiner P, Fernanadez-Salazar L, Gasbarrini A, Vaira D, Puig I, Megraud F, O'Morain C, and Gisbert JP
Subjects: inorganic chemicals, Helicobacter pylori, Pylera, Helicobacter pylori, Pylera, bismuth, eradication, quadruple, quadruple, equipment and supplies, bacterial infections and mycoses, digestive system, digestive system diseases, bismuth, eradication
Abstract: BACKGROUND: There has been resurgence in the use of bismuth quadruple therapy (proton pump inhibitor, bismuth, tetracycline and metronidazole) for treating Helicobacter pylori infection thanks to a three-in-one single-capsule formulation. OBJECTIVE: To evaluate the effectiveness and safety of the single-capsule bismuth quadruple therapy. METHODS: Data were collected in a multicentre, prospective registry of the clinical practice of gastroenterologists on the management of H. pylori infection, where patients were registered at the Asociacion Espanola de Gastroenterologia REDCap database on an electronic case report form until January 2020. Effectiveness by modified intention-to-treat and per-protocol as well as multivariable analysis were performed. Independent factors evaluated were: age, gender, indication, compliance, proton pump inhibitor dose and treatment line. RESULTS: Finally, 2100 patients were prescribed single-capsule bismuth quadruple therapy following the technical sheet (i.e. three capsules every 6 hours for 10 days). The majority of these patients were naive (64%), with an average age of 50 years, 64% women and 16% with peptic ulcer. An overall modified intention-to-treat effectiveness of 92% was achieved. Eradication was over 90% in first-line treatment (95% modified intention-to-treat, n=1166), and this was maintained as a rescue therapy, both in second (89% modified intention-to-treat, n=375) and subsequent lines of therapy (third to sixth line: 92% modified intention-to-treat, n=236). Compliance was the factor most closely associated with treatment effectiveness. Adverse events were generally mild to moderate, and 3% of patients reported a severe adverse event, leading to discontinuation of treatment in 1.7% of cases. CONCLUSIONS: Single-capsule bismuth quadruple therapy achieved H. pylori eradication in approximately 90% of patients in real-world clinical practice, both as a first-line and rescue treatment, with good compliance and a favourable safety profile.
Published: 2020

14. Antibiotic resistance trends of Helicobacter pylori naïve patients in the period 2013-2019: analysis of the European registry on H. pylori management (HP-EUREG)

Author: Bujanda L., Nyssen O.P., Cosme A., Bordin D.S., Tepeš B., Pere-Aisa A., Vaira D., Caldas Álvarez M., Castro-Fernandez M., Lerang F., Leja M., Rodrigo L., Rokkas T., Kupcinskas L., Perez-Lasala J., Jonaitis L., Shvets O., Gasbarrini A., Simsek H., Axon A.T.R., Buzas G.M., Machado J.C., Niv Y., Boyanova L., Goldis A., Lamy V., Tonkić Ante, Marlicz W., Beglinger C., Venerito M., Bytzer P., Capelle L.G., Milosavljevic T., Veijola L.I., Molina Infante J., Vologhzanina L., Fadeenko G., Ariño I., Fiorini G., Resinas E., Muñoz R., Puig I., Megraud F., O’ Morain C., Gisbert J.P.
Subjects: Helicobacter pylori, antibiotic resistance
Abstract: Introduction: Bacterial antibiotic resistance changes over time based on multiple factors. It is essential to study these trends to apply preventive strategies to help reducing such resistances.Aims & Methods: To conduct a time-trend analysis of the antibiotic resistance to H. pylori infection in the European Registry on H. pylori (Hp-EuReg). International multicenter prospective non- interventional European Registry on H. pylori Management (Hp-EuReg) aiming to evaluate the decisions and outcomes of H. pylori infection by European gastroenterologists. All infected adult patients diagnosed with culture and with a result of the antibiotic resistance test were registered at AEG-REDCap e-CRF from 2013 to 2019.Results: A total of 32, 447 patients were included, and culture was performed in 3, 474 (11%), where 2, 483 näive patients were included for analysis. Resistance to at least one antibiotic was described in 57% of the patients. Resistance to metronidazole (27%) was most frequent, whereas resistance to tetracycline and amoxicillin was below 1%. Clarithromycin resistance remained above 15% throughout the studied years. A significant decrease in the metronidazole resistance rate was observed between 2013 (38%) and 2018 (21%).Conclusion: In naïve patients, resistance to clarithromycin remained above 15% in the period 2013-2019. A progressive decrease in metronidazole resistance was observed. No increasing or decreasing trend was observed in the bacterial resistance to other antibiotics.
Published: 2020

15. Helicobacter pylori first-line and rescue treatments in patients allergic to penicillin: Experience from the European Registry on H pylori management (Hp-EuReg)

Author: Nyssen, O. P., Perez-Aisa, A., Tepes, B., Rodrigo-Saez, L., Romero, P. M., Lucendo, A., Castro-Fernandez, M., Phull, P., Barrio, J., Bujanda, L., Ortuno, J., Areia, M., Brglez Jurecic, N., Huguet, J. M., Alcaide, N., Voynovan, I., Maria Botargues Bote, J., Modolell, I., Perez Lasala, J., Arino, I., Jonaitis, L., Dominguez-Cajal, M., Buzas, G., Lerang, F., Perona, M., Bordin, D., Axon, T., Gasbarrini, Antonio, Marcos Pinto, R., Niv, Y., Kupcinskas, L., Tonkic, A., Leja, M., Rokkas, T., Boyanova, L., Shvets, O., Venerito, M., Bytzer, P., Goldis, A., Simsek, I., Lamy, V., Przytulski, K., Kunovsky, L., Capelle, L., Milosavljevic, T., Caldas, M., Garre, A., Megraud, F., O'Morain, C., Gisbert, J. P., Hinojosa, J., Fernandez, N., Molina Infante, J., Alonso Galan, H., Di Maira, T., Alves, S. I., Saraiva, S., Elvas, L., Brito, D., Teresa Cadime, A., Lampic, P., Gruncic, A., Leban, V., Ferrer, L., Fernandez Salazar, L., Lanas, A., Kristensen, V., Brackmann, S., Delchier, J. C., Anton, C., Gomez Rodriguez, B. J., Pellicano, R., Boltin, D., and Gastroenterology & Hepatology
Subjects: medicine.medical_specialty, Allergy, Settore MED/12 - GASTROENTEROLOGIA, allergic, Penicillins, Gastroenterology, Helicobacter Infections, Drug Hypersensitivity, 03 medical and health sciences, 0302 clinical medicine, Levofloxacin, Metronidazole, Clarithromycin, Internal medicine, bismuth, medicine, Humans, Prospective Studies, Registries, Adverse effect, levofloxacin, biology, Helicobacter pylori, business.industry, Settore MED/09 - MEDICINA INTERNA, allergy, clarithromycin, penicillin, Proton Pump Inhibitors, General Medicine, Tetracycline, biology.organism_classification, medicine.disease, Anti-Bacterial Agents, 3. Good health, Penicillin, Regimen, Infectious Diseases, 030220 oncology & carcinogenesis, Drug Therapy, Combination, 030211 gastroenterology & hepatology, business, medicine.drug
Abstract: Background Experience in Helicobacter pylori eradication treatment of patients allergic to penicillin is very scarce. A triple combination with a PPI, clarithromycin (C), and metronidazole (M) is often prescribed as the first option, although more recently the use of a quadruple therapy with PPI, bismuth (B), tetracycline (T), and M has been recommended. Aim To evaluate the efficacy and safety of first-line and rescue treatments in patients allergic to penicillin in the "European Registry of H pylori management" (Hp-EuReg). Methods A systematic prospective registry of the clinical practice of European gastroenterologists (27 countries, 300 investigators) on the management of H pylori infection. An e-CRF was created on AEG-REDCap. Patients with penicillin allergy were analyzed until June 2019. Results One-thousand eighty-four patients allergic to penicillin were analyzed. The most frequently prescribed first-line treatments were as follows: PPI + C + M (n = 285) and PPI + B + T + M (classic or Pylera(R); n = 250). In first line, the efficacy of PPI + C + M was 69%, while PPI + B + T + M reached 91% (P < .001). In second line, after the failure of PPI + C + M, two rescue options showed similar efficacy: PPI + B + T + M (78%) and PPI + C + levofloxacin (L) (71%) (P > .05). In third line, after the failure of PPI + C + M and PPI + C + L, PPI + B + T + M was successful in 75% of cases. Conclusion In patients allergic to penicillin, a triple combination with PPI + C + M should not be generally recommended as a first-line treatment, while a quadruple regimen with PPI + B + T + M seems to be a better option. As a rescue treatment, this quadruple regimen (if not previously prescribed) or a triple regimen with PPI + C + L could be used but achieved suboptimal (
Published: 2020

16. First line H. pylori eradication therapy in Europe: results from 24,882 cases of the European registry on H. pylori management (HP-EUREG)

Author: Nyssen O.P., Bordin D.S., Tepeš B., Perez Aisa M.Á., Caldas Álvarez M., Bujanda Fernández de Piérola L., Pabon Carrasco M., Castro Fernandez M., Lerang F., Leja M., Rokkas T., Kupcinskas L., Jonaitis L., Shvets O., Gasbarrini A., Axon A., Şimşek H., Buzás G.M., Machado J.C.L., Niv Y., Boyanova L., Rodrigo L., Perez-Lasala J., Goldis E.-A., Lamy V., Tonkić Ante, Przytulski K., Beglinger C., Venerito M., Bytzer P., Capelle L., Milivojević V., Veijola L., Molina Infante J., Vologzhanina L., Dino V., Fadeenko G., Ariño Pérez I., Fiorini G., Garre A., Keko-Huerga A., Heluwaert F., Garrido J., Fernandez Perez C., Puig I., Megraud F., O’Morain C., Gisbert J.P.
Subjects: Helicobacter pylori, eradication therapy
Abstract: Introduction: The best approach for Helicobacter pylori management remains unclear. An audit process is essential to ensure clinical practice is aligned with best standards of care.Aims & Methods: International multicentre prospective non-interventional registry starting in 2013 aimed to evaluate the decisions and outcomes in H. pylori management by European gastroenterologists. Patients were registered in an e-CRF by AEG-REDCap up to April 2020. Variables included: demographics, previous eradication attempts, prescribed treatment, adverse events, and outcomes. Modified intention-to-treat (mITT) and per-protocol (PP) analyses were performed and data were subject to quality review to ensure information reliability.Results: In total 36, 319 patients from 29 European countries were evaluated and 24, 882 (70%) first-line empirical H. pylori treatments were included for analysis. Triple therapy with amoxicillin and clarithromycin was most commonly prescribed (40%), followed by concomitant treatment (19%) and bismuth quadruple (Pylera®) (10%) achieving 83%, 91% and 95% mITT eradication rate, respectively. Over 90% effectiveness was obtained only with 10 and 14-day bismuth quadruple or 14-day concomitant treatment (Table). Longer treatment duration, higher acid inhibition and compliance were associated with higher eradication rates.Conclusion: Management of H. pylori infection by European gastroenterologists is heterogeneous. Only quadruple therapies lasting at least ten days are able to achieve over 90% eradication rates.
Published: 2020

17. THIRD-LINE RESCUE THERAPY WITH BISMUTH-CONTAINING QUADRUPLE REGIMEN AFTER FAILURE OF TWO TREATMENTS (WITH CLARITHROMYCIN AND LEVOFLOXACIN) TO ERADICATE HELICOBACTER PYLORI INFECTION: Abstract no.: P11.18

Author: Gisbert, J. P., Perez-Aisa, A., Rodrigo, L., Molina-Infante, J., Modolell, I., Bermejo, F., Castro-Fernandez, M., Anton, R., Sacristan, B., Cosme, A., Barrio, J., Harb, Y., Gonzalez-Barcenas, M., Fernandez-Bermejo, M., Algaba, A., Marin, A. C., and McNicholl, A. G.
Published: 2013

18. RANDOMISED CLINICAL TRIAL COMPARING SEQUENTIAL AND CONCOMITANT THERAPIES FOR HELICOBACTER PYLORI ERADICATION IN ROUTINE CLINICAL PRACTICE: Abstract no.: P11.07

Author: McNicholl, A. G., Marin, A. C., Molina-Infante, J., Castro-Fernandez, M., Barrio, J., Ducons, J., Calvet, X., de la Coba, C., Montoro, M., Bory, F., Perez-Aisa, A., Forne, M., Ramas, M., Millan, R., Araguren, P., Garcia-Iglesias, P., Belloc, B., Bessa, X., Sainz, E., Gisbert, J. L., Lamas, E., Marcos, E., Moreno, M. I., Abad-Santos, F., and Gisbert, J. P.
Published: 2013

19. SECOND-LINE RESCUE THERAPY WITH LEVOFLOXACIN AFTER FAILURE OF TREATMENT TO ERADICATE HELICOBACTER PYLORI INFECTION: TIME TRENDS IN A SPANISH MULTICENTER STUDY OF 1300 PATIENTS: Abstract no.: P11.01

Author: Gisbert, J. P., Perez-Aisa, A., Bermejo, F., Castro-Fernandez, M., Almela, P., Barrio, J., Cosme, A., Modolell, I., Bory, F., Fernandez-Bermejo, M., Rodrigo, L., Ortuño, J., Sanchez-Pobre, P., Khorrami, S., Franco, A., Tomas, A., Guerra, I., Lamas, E., Ponce, J., and Calvet, X.
Published: 2013

20. FOURTH-LINE RESCUE THERAPY WITH RIFABUTIN IN PATIENTS WITH THREE H. PYLORI ERADICATION FAILURES: Abstract no.: P11.05

Author: Gisbert, J. P., Castro-Fernandez, M., Perez-Aisa, A., Cosme, A., Molina-Infante, J., Rodrigo, L., Modolell, I., Cabriada, J. L., Gisbert, J. L., Lamas, E., Marcos, S., and Calvet, X.
Published: 2013

21. Fourth-line rescue therapy with rifabutin in patients with three Helicobacter pylori eradication failures

Author: Gisbert, J. P., Castro-Fernandez, M., Perez-Aisa, A., Cosme, A., Molina-Infante, J., Rodrigo, L., Modolell, I., Cabriada, J. L., Gisbert, J. L., Lamas, E., Marcos, E., and Calvet, X.
Published: 2012
Full Text: View/download PDF

22. 130 - COMPARACIÓN DE LA EFECTIVIDAD DE LOS TRATAMIENTOS ERRADICADORES MÁS FRECUENTES ENTRE LAS POBLACIONES MÁS MAYORES Y MÁS JÓVENES DE EUROPA: DATOS DEL REGISTRO EUROPEO SOBRE EL MANEJO DE LA INFECCIÓN POR HELICOBACTER PYLORI (HP-EUREG)

Author: Jonaitis, Paulius, Nyssen, Olga P., Saracino, Ilaria Maria, Fiorini, Giulia, Vaira, Dino, Pérez-Aísa, Ángeles, Tepes, Bojan, Castro-Fernández, M., Pabón-Carrasco, Manuel, Keco-Huerga, Alma, Voynovan, Irina, Lucendo, Alfredo J, Lanas, Ángel, Martínez-Domínguez, Samuel J, Almajano, Enrique Alfaro, Rodrigo, Luis, Vologzanina, Ludmila, Jurecic, Natasa Brglez, Denkovski, Maja, Bujanda, Luis, Mahmudov, Umud, Leja, Mrcis, Lerang, Frode, Babayeva, Gülüstan, Bordin, Dmitry S., Gasbarrini, Antonio, Kupcinskas, Juozas, Gridnyev, Oleksiy, Rokkas, Theodore, Marcos-Pinto, Ricardo, Phull, Perminder S., Smith, Sinead M., Tonki, Ante, Boltin, Doron, Buzás, György Miklós, Kunovský, Lumír, imek, Halis, Matysiak-Budnik, Tamara, Milivojevic, Vladimir, Marlicz, Wojciech, Venerito, Marino, Boyanova, Lyudmila, Doulberis, Michael, Capelle, Lisette G., Cano-Català, Anna, Moreira, Leticia, Mégraud, Francis, O’Morain, Colm, Gisbert, Javier P., and Jonaitis, Laimas
Published: 2023
Full Text: View/download PDF

23. C01/43 HEPATITIS C VIRUS INFECTION IN PREGNANCY AND AFTER DELIVERY

Author: Romero-Gomez, M., Suarez-Garcia, E., Casanovas, J., Castilla, L., Nogales, M. C., Vargas, J., and Castro-Fernandez, M.
Published: 1997

24. Measurement of top quark polarisation in t-channel single top quark production

Author: Khachatryan, V. Sirunyan, A. M. Tumasyan, A. Adam, W. and Asilar, E. Bergauer, T. Brandstetter, J. Brondolin, E. and Dragicevic, M. Eroe, J. Flechl, M. Friedl, M. and Fruehwirth, R. Ghete, V. M. Hartl, C. Hoermann, N. and Hrubec, J. Jeitler, M. Knuenz, V. Koenig, A. Krammer, M. and Kraetschmer, I. Liko, D. Matsushita, T. Mikulec, I. and Rabady, D. Rahbaran, B. Rohringer, H. Schieck, J. and Schoefbeck, R. Strauss, J. Treberer-Treberspurg, W. and Waltenberger, W. Wulz, C-E Mossolov, V. Shumeiko, N. and Gonzalez, J. Suarez Alderweireldt, S. Cornelis, T. De Wolf, E. A. Janssen, X. Knutsson, A. Lauwers, J. Luyckx, S. and Van de Klundert, M. Van Haevermaet, H. Van Mechelen, P. and Van Remortel, N. Van Spilbeeck, A. Abu Zeid, S. Blekman, F. and D'Hondt, J. Daci, N. De Bruyn, I. Deroover, K. and Heracleous, N. Keaveney, J. Lowette, S. Moreels, L. and Olbrechts, A. Python, Q. Strom, D. Tavernier, S. Van Doninck, W. Van Mulders, P. Van Onsem, G. P. Van Parijs, I. and Barria, P. Brun, H. Caillol, C. Clerbaux, B. De Lentdecker, G. Fasanella, G. Favart, L. Grebenyuk, A. and Karapostoli, G. Lenzi, T. Leonard, A. Maerschalk, T. and Marinov, A. Pernie, L. Randle-Conde, A. Seva, T. Vander Velde, C. Vanlaer, P. Yonamine, R. Zenoni, F. Zhang, F. and Beernaert, K. Benucci, L. Cimmino, A. Crucy, S. and Dobur, D. Fagot, A. Garcia, G. Gul, M. Mccartin, J. and Rios, A. A. Ocampo Poyraz, D. Ryckbosch, D. Salva, S. and Sigamani, M. Tytgat, M. Van Driessche, W. Yazgan, E. and Zaganidis, N. Basegmez, S. Beluffi, C. Bondu, O. and Brochet, S. Bruno, G. Caudron, A. Ceard, L. Da Silveira, G. G. Delaere, C. Favart, D. Forthomme, L. Giammanco, A. and Hollar, J. Jafari, A. Jez, P. Komm, M. Lemaitre, V. and Mertens, A. Musich, M. Nuttens, C. Perrini, L. Pin, A. Piotrzkowski, K. Popov, A. Quertenmont, L. Selvaggi, M. Marono, M. Vidal Beliy, N. Hammad, G. H. Alda Junior, W. L. Alves, F. L. Alves, G. A. Brito, L. Correa Martins Junior, M. Hamer, M. Hensel, C. Mora Herrera, C. Moraes, A. Pol, M. 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Flowers, S. Hart, A. Hill, C. and Hughes, R. Ji, W. Kotov, K. Ling, T. Y. Liu, B. and Luo, W. Puigh, D. Rodenburg, M. Winer, B. L. Wulsin, H. W. Driga, O. Elmer, P. Hardenbrook, J. Hebda, P. and Koay, S. A. Lujan, P. Marlow, D. Medvedeva, T. Mooney, M. Olsen, J. Palmer, C. Piroue, P. Saka, H. and Stickland, D. Tully, C. Zuranski, A. Barnes, V. E. and Benedetti, D. Bortoletto, D. Gutay, L. Jha, M. K. Jones, M. Jung, K. Miller, D. H. Neumeister, N. Radburn-Smith, B. C. Shi, X. Shipsey, I. Silvers, D. Sun, J. and Svyatkovskiy, A. Wang, F. Xie, W. Xu, L. Parashar, N. and Stupak, J. Adair, A. Akgun, B. Chen, Z. Ecklund, K. M. Geurts, F. J. M. Guilbaud, M. Li, W. Michlin, B. and Northup, M. Padley, B. P. Redjimi, R. Roberts, J. Rorie, J. Tu, Z. Zabel, J. Betchart, B. Bodek, A. de Barbaro, P. Demina, R. Eshaq, Y. Ferbel, T. Galanti, M. and Garcia-Bellido, A. Han, J. Harel, A. Hindrichs, O. and Khukhunaishvili, A. Petrillo, G. Tan, P. Verzetti, M. and Arora, S. Barker, A. Chou, J. P. Contreras-Campana, C. and Contreras-Campana, E. Ferencek, D. Gershtein, Y. Gray, R. and Halkiadakis, E. Hidas, D. Hughes, E. Kaplan, S. and Elayavalli, R. Kunnawalkam Lath, A. Nash, K. Panwalkar, S. and Park, M. Salur, S. Schnetzer, S. Sheffield, D. and Somalwar, S. Stone, R. Thomas, S. Thomassen, P. Walker, M. Foerster, M. Riley, G. Rose, K. Spanier, S. York, A. Bouhali, O. Hernandez, A. Castaneda Celik, A. and Dalchenko, M. De Mattia, M. Delgado, A. Dildick, S. and Eusebi, R. Gilmore, J. Huang, T. Kamon, T. Krutelyov, V. and Mueller, R. Osipenkov, I. Pakhotin, Y. Patel, R. and Perloff, A. Rose, A. Safonov, A. Tatarinov, A. Ulmer, K. A. Akchurin, N. Cowden, C. Damgov, J. Dragoiu, C. and Dudero, P. R. Faulkner, J. Kunori, S. Lamichhane, K. and Lee, S. W. Libeiro, T. Undleeb, S. Volobouev, I. Appelt, E. Delannoy, A. G. Greene, S. Gurrola, A. Janjam, R. and Johns, W. Maguire, C. Melo, A. Ni, H. Sheldon, P. and Snook, B. Tuo, S. Velkovska, J. Xu, Q. Arenton, M. W. and Cox, B. Francis, B. Goodell, J. Hirosky, R. and Ledovskoy, A. Li, H. Lin, C. Neu, C. Sinthuprasith, T. and Sun, X. Wang, Y. Wolfe, E. Wood, J. Xia, F. and Clarke, C. Harr, R. Karchin, P. E. Don, C. Kottachchi Kankanamge Lamichhane, P. Sturdy, J. Belknap, D. A. and Carlsmith, D. Cepeda, M. Dasu, S. Dodd, L. Duric, S. and Gomber, B. Grothe, M. Hall-Wilton, R. Herndon, M. Herve, A. Klabbers, P. Lanaro, A. Levine, A. Long, K. and Loveless, R. Mohapatra, A. Ojalvo, I. Perry, T. Pierro, G. A. Polese, G. Ruggles, T. Sarangi, T. Savin, A. and Smith, N. Smith, W. H. Taylor, D. Woods, N. CMS Collaboration
Subjects: High Energy Physics::Phenomenology, Physics::Atomic and Molecular Clusters, High Energy Physics::Experiment
Abstract: A first measurement of the top quark spin asymmetry, sensitive to the top quark polarisation, in t-channel single top quark production is presented. It is based on a sample of pp collisions at a centre-of-mass energy of 8TeV corresponding to an integrated luminosity of 19.7 fb(-1). A high-purity sample of t-channel single top quark events with an isolated muon is selected. Signal and background components are estimated using a fit to data. A differential cross section measurement, corrected for detector effects, of an angular observable sensitive to the top quark polarisation is performed. The differential distribution is used to extract a top quark spin asymmetry of 0.26 +/- 0.03(stat) +/- 0.10(syst), which is compatible with a p-value of 4.6% with the standard model prediction of 0.44.
Published: 2016

25. Remote sensing of harmful algal events in optically complex waters using regionally specific neural network-based algorithms for MERIS data

Author: Gonzalez Vilas, L., primary, Castro Fernandez, M., additional, Spyrakos, E., additional, and Torres Palenzuela, J., additional
Published: 2013
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26. Invasive pulmonary aspergillosis in a young man with Crohn’s disease

Author: Rojas-Feria, M., primary, Eslam, M., additional, and Castro-Fernandez, M., additional
Published: 2012
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27. Su1722a Eradication of Helicobacter pylori for the prevention of peptic ulcer rebleeding: Long-term follow-up study of 1,000 patients

Author: Gisbert, J.P., primary, Garcia-Gravalos, R., additional, Calvet, X., additional, Cosme, A., additional, Almela, P., additional, Benages, A., additional, Feu, F., additional, Piqué, J., additional, Bory, F., additional, Canete, N., additional, Santolaria, S., additional, Montoro, M.A., additional, Aznarez, R., additional, Borda, F., additional, Castro-Fernandez, M., additional, Fernandez, N., additional, Aisa, A. Perez, additional, and Gisbert, J.P., additional
Published: 2012
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28. Recurrence of Helicobacter pylori infection after several eradication therapies: long-term follow-up of 1000 patients

Author: GISBERT, J. P., primary, LUNA, M., additional, GOMEZ, B., additional, HERRERIAS, J. M., additional, MONES, J., additional, CASTRO-FERNANDEZ, M., additional, SANCHEZ-POBRE, P., additional, COSME, A., additional, OLIVARES, D., additional, and PAJARES, J. M., additional
Published: 2006
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29. Acute pancreatitis associated withCampylobacter enteritis

Author: Castilla-Higuero, L., Castro-Fernandez, M., and Guerrero-Jimenez, P.
Published: 1989
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30. Remote sensing of harmful algal events in optically complex waters using regionally specific neural network-based algorithms for MERIS data

Author: Hadjimitsis, Diofantos G., Themistocleous, Kyriacos, Michaelides, Silas, Papadavid, George, Gonzalez Vilas, L., Castro Fernandez, M., Spyrakos, E., and Torres Palenzuela, J.
Published: 2013
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31. Pan-European Registry on H. pylori management (Hp-EuReg): bacterial resistance of 2684 H. pylori isolates

Author: Mcnicholl, A. G., Nyssen, O. P., Bordin, D., Tepes, B., Perez-Aisa, A., Vaira, D., Luis Bujanda, Castro-Fernandez, M., Lerang, F., Leja, M., Rodrigo, L., Rokkas, T., Jonaitis, L. V., Perez-Lasala, J., Shvets, O., Gasbarrini, A., Simsek, H., Axon, A., Buzas, G. M., Machado, J. C., Niv, Y., Boyanova, L., Goldis, A., Lamy, V., Katicic, M., Przytulski, K., Venerito, M., Bytzer, P., Milosavljevic, T., Fiorini, G., Donday, M. G., Arino, I., Veijola, L. I., Molina-Infante, J., Megraud, F., O Morain, C., and Gisbert, J. P.

32. Pan-European Registry on H. pylori management (Hp-EuReg): Impact of resistance on efficacy

Author: Mcnicholl, A. G., Nyssen, O. P., Bordin, D. S., Tepes, B., Perez-Aisa, A., Vaira, D., Caldas, M., Bujanda, L., Castro-Fernandez, M., Lerang, F., Leja, M., Luis Rodrigo, Rokkas, T., Jonaitis, L. V., Perez-Lasala, J., Shvets, O., Gasbarrini, A., Simsek, H., Axon, A., Buzas, G. M., Machado, J. C., Niv, Y., Boyanova, L., Goldis, A., Lamy, V., Katicic, M., Przytulski, K., Venerito, M., Bytzer, P., Milosavljevic, T., Fiorini, G., Donday, M. G., Arino, I., Capelle, L. G., Veijola, L. I., Molina-Infante, J., Vologhzanina, L., Fadeenko, G., O Morain, C., Megraud, F., and Gisbert, J. P.

33. Fourth-Line Rescue Therapy With Rifabutin in Patients With Three H. pylori Eradication Failures

Author: Gisbert, J. P., Castro-Fernandez, M., Perez-Aisa, A., Cosme, A., Molina-Infante, J., Luis Rodrigo, Modolell, I., Cabriada, J., Gisbert, J. L., Lamas, E., Marcos, S., and Calvet, X.

34. Pan-European Registry on H. pylori management (Hp-EuReg): interim analysis of 16 600 first-line treatments

Author: Mcnicholl, A. G., Nyssen, O. P., Bordin, D. S., Tepes, B., Perez-Aisa, A., Vaira, D., Caldas, M., Bujanda, L., Castro-Fernandez, M., Lerang, F., Leja, M., Luis Rodrigo, Rokkas, T., Jonaitis, L. V., Perez-Lasala, J., Shvets, O., Gasbarrini, A., Simsek, H., Axon, A., Buzas, G. M., Machado, J. C., Niv, Y., Boyanova, L., Goldis, A., Lamy, V., Katicic, M., Przytulski, K., Venerito, M., Bytzer, P., Milosavljevic, T., Fiorini, G., Donday, M. G., Arino, I., Capelle, L. G., Veijola, L. I., Molina-Infante, J., Vologhzanina, L., Fadeenko, G., Ramas, M., Megraud, F., O Morain, C., and Gisbert, J. P.

35. Pan-European Registry on H. pylori management (Hp-EuReg): analysis of 3532 second-line treatments

Author: Nyssen, O. P., Mcnicholl, A. G., Vaira, D., Perez-Aisa, A., Caldas, M., Tepes, B., Bordin, D., Bujanda, L., Castro-Fernandez, M., Lerang, F., Leja, M., Luis Rodrigo, Rokkas, T., Jonaitis, L. V., Perez-Lasala, J., Shvets, O., Gasbarrini, A., Simsek, H., Axon, A., Buzas, G., Machado, J. C., Niv, Y., Boyanova, L., Goldis, A., Lamy, V., Katicic, M., Przytulski, K., Venerito, M., Bytzer, P., Milosavljevic, T., Fiorini, G., Donday, M. G., Arino, I., Capelle, L. G., Veijola, L. I., Molina-Infante, J., Vologhzanina, L., Ramas, M., O Morain, C., Megraud, F., and Gisbert, J. P.

36. [Septic arthritis caused by Streptococcus agalactiae in a patient with liver cirrhosis]

Author: JOSE GUTIERREZ-FERNANDEZ, Jimenez Ocana, C., Martin Mazuelos, E., Castro Fernandez, M., and Lopez Cortes, L.

37. SECOND-LINE RESCUE THERAPY WITH LEVOFLOXACIN AFTER H. PYLORI TREATMENT FAILURE. TIME TRENDS OF ERADICATION IN A SPANISH MULTICENTER STUDY OF 936 PATIENTS

Author: Gisbert, J. P., Perez-Aisa, A., Bermejo, F., Almela, P., Castro-Fernandez, M., Barrio, J., Cosme, A., Bory, F., Modolell, I., Fernandez-Bermejo, M., Luis Rodrigo, Ortuno, J., Sanchez-Pobre, P., Khorrami, S., Franco, A., Guerra, I., Lamas, E., Tomas, A., Ponce, J., and Calvet, X.

38. Pan-European Registry on H. pylori Management (Hp-EuReg): first-line treatment use and efficacy trends from 2013 to 2018

Author: Mcnicholl, A. G., Nyssen, O. P., Bordin, D. S., Tepes, B., Perez-Aisa, A., Vaira, D., Caldas, M., Luis Bujanda, Castro-Fernandez, M., Lerang, F., Leja, M., Rodrigo, L., Rokkas, T., Jonaitis, L. V., Perez-Lasala, J., Shvets, O., Gasbarrini, A., Simsek, H., Axon, A., Buzas, G., Machado, J. C., Niv, Y., Boyanova, L., Goldis, A., Lamy, V., Katicic, M., Przytulski, K., Venerito, M., Bytzer, P., Milosavljevic, T., Fiorini, G., Donday, M. G., Arino, I., Capelle, L. G., Veijola, L. I., Molina-Infante, J., Vologhzanina, L., Fadeenko, G., Ramas, M., Megraud, F., O Morain, C., and Gisbert, J. P.

39. European Registry on Helicobacter pylori management: Single-capsule bismuth quadruple therapy is effective in real-world clinical practice

Author: Nyssen, Olga P, Perez-Aisa, Angeles, Castro-Fernandez, Manuel, Pellicano, Rinaldo, Huguet, Jose M, Rodrigo, Luis, Ortuñ, Juan, O, Gomez-Rodriguez, Blas J, Pinto, Ricardo M, Areia, Miguel, Perona, Monica, Nuñez, Oscar, Romano, Marco, Gravina, Antonietta G, Pozzati, Liliana, Fernandez-Bermejo, Miguel, Venerito, Marino, Malfertheiner, Peter, Fernanadez-Salazar, Luis, Gasbarrini, Antonio, Vaira, Dino, Puig, Ignasi, Megraud, Francis, O'Morain, Colm, Gisbert, Javier P, Hp-EuReg investigators, UAM. Departamento de Medicina, Nyssen O.P., Perez-Aisa A., Castro-Fernandez M., Pellicano R., Huguet J.M., Rodrigo L., Ortun J., Gomez-Rodriguez B.J., Pinto R.M., Areia M., Perona M., Nunez O., Romano M., Gravina A.G., Pozzati L., Fernandez-Bermejo M., Venerito M., Malfertheiner P., Fernanadez-Salazar L., Gasbarrini A., Vaira D., Puig I., Megraud F., O'Morain C., Gisbert J.P., Nyssen, Op, Perez-Aisa, A, Castro-Fernandez, M, Pellicano, R, Huguet, Jm, Rodrigo, L, Ortuño, J, Gomez-Rodriguez, Bj, Pinto, Rm, Areia, M, Perona, M, Nuñez, O, Romano, M, Gerarda Gravina, A, Pozzati, L, Fernandez-Bermejo, M, Venerito, M, Malfertheiner, P, Fernanadez-Salazar, L, Gasbarrini, A, Vaira, D, Puig, I, Megraud, F, O'Morain, C, and Gisbert, Jp
Subjects: Registrie, Male, Helicobacter pylori infection, Proton Pump Inhibitor, Intention to Treat Analysi, Gastrointestinal Diseases, Drug Resistance, Gastroenterology, Bismuth, 0302 clinical medicine, Drug Combination, eradication, Registries, Capsule, biology, Bacterial, Middle Aged, Anti-Bacterial Agents, Intention to Treat Analysis, Clinical Practice, Europe, Drug Combinations, Oncology, 030220 oncology & carcinogenesis, 030211 gastroenterology & hepatology, Female, Original Article, Human, medicine.drug, inorganic chemicals, Adult, medicine.medical_specialty, Adolescent, Medicina, medicine.drug_class, Tetracycline, Gastrointestinal Disease, Settore MED/12 - GASTROENTEROLOGIA, quadruple, Proton-pump inhibitor, chemistry.chemical_element, Capsules, digestive system, Helicobacter Infections, Medication Adherence, Neurogastroenterology, 03 medical and health sciences, Young Adult, Internal medicine, Metronidazole, Anti-Bacterial Agent, Drug Resistance, Bacterial, bismuth, medicine, Humans, Helicobacter pylori, business.industry, Settore MED/09 - MEDICINA INTERNA, Proton Pump Inhibitors, equipment and supplies, bacterial infections and mycoses, biology.organism_classification, Pylera, digestive system diseases, chemistry, business, Helicobacter Infection
Abstract: Artículo escrito por un elevado número de autores, solo se referencian el que aparece en primer lugar, el nombre del grupo de colaboración, si le hubiere, y los autores pertenecientes a la UAM, Background: There has been resurgence in the use of bismuth quadruple therapy (proton pump inhibitor, bismuth, tetracycline and metronidazole) for treating Helicobacter pylori infection thanks to a three-in-one single-capsule formulation. Objective: To evaluate the effectiveness and safety of the single-capsule bismuth quadruple therapy. Methods: Data were collected in a multicentre, prospective registry of the clinical practice of gastroenterologists on the management of H. pylori infection, where patients were registered at the Asociación Española de Gastroenterologia REDCap database on an electronic case report form until January 2020. Effectiveness by modified intention-to-treat and per-protocol as well as multivariable analysis were performed. Independent factors evaluated were: age, gender, indication, compliance, proton pump inhibitor dose and treatment line. Results: Finally, 2100 patients were prescribed single-capsule bismuth quadruple therapy following the technical sheet (i.e., three capsules every 6 h for 10 days). The majority of these patients were naive (64%), with an average age of 50 years, 64% women and 16% with peptic ulcer. An overall modified intention-to-treat effectiveness of 92% was achieved. Eradication was over 90% in first-line treatment (95% modified intention-to-treat, n = 1166), and this was maintained as a rescue therapy, both in second (89% modified intention-to-treat, n = 375) and subsequent lines of therapy (third to sixth line: 92% modified intention-to-treat, n = 236). Compliance was the factor most closely associated with treatment effectiveness. Adverse events were generally mild to moderate, and 3% of patients reported a severe adverse event, leading to discontinuation of treatment in 1.7% of cases. Conclusions: Single-capsule bismuth quadruple therapy achieved H. pylori eradication in approximately 90% of patients in real-world clinical practice, both as a first-line and rescue treatment, with good compliance and a favourable safety profile, The author(s) would like to thank the Spanish Association of Gastroenterology (AEG) for providing the electronic case report form service free of charge. The authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This project was promoted and funded by the European Helicobacterand Microbiota Study Group, and received support from the Spanish Association of Gastroenterology (AEG) and the Centro de Investigación Biomedica en Red de Enfermedades Hepaticas y Digestivas
Published: 2020

40. Evolution of the use, effectiveness and safety of bismuth-containing quadruple therapy for Helicobacter pylori infection between 2013 and 2021: results from the European registry on H. pylori management (Hp-EuReg).

Author: Olmedo L, Calvet X, Gené E, Bordin DS, Voynovan I, Castro-Fernandez M, Pabón-Carrasco M, Keco-Huerga A, Perez-Aisa Á, Lucendo AJ, Rodrigo L, Sarsenbaeva AS, Khlinov IB, Fadieienko G, Zaytsev O, Lanas Á, Martínez-Domínguez SJ, Alfaro E, Jonaitis L, Núñez Ó, Pellicano R, Hernández L, Gridnyev O, Kupcinskas J, Gasbarrini A, Boltin D, Niv Y, Babayeva G, Marcos-Pinto R, Tepes B, Venerito M, Papp V, Lerang F, Leja M, Phull PS, Marlicz W, Doulberis M, Smith SM, Milivojevic V, Kunovsky L, Mestrovic A, Matysiak-Budnik T, Simsek H, Cano-Català A, Puig I, Moreira L, Parra P, Nyssen OP, Megraud F, O'Morain C, and Gisbert JP
Abstract: Background: Bismuth quadruple therapies (BQTs) including bismuth, a proton pump inhibitor (PPI) and two antibiotics have been shown to be highly effective for treating Helicobacter pylori infection even in areas of high bacterial antibiotic resistance., Objective: To describe the time trends of use, effectiveness and safety of BQT in Europe using the European Registry on Helicobacter pylori Management (Hp-EuReg)., Design: Patients registered in the Hp-EuReg from 2013 to 2021 who had received BQT were included. The regimens prescribed, the number of eradication attempts, effectiveness, adherence and safety were analysed. The effectiveness was assessed by modified intention to treat (mITT). Time-trend and multivariate analyses were performed to determine variables that predicted treatment success., Results: Of the 49 690 patients included in the Hp-EuReg, 15 582 (31%) had received BQT. BQT use increased from 8.6% of all treatments in 2013 to 39% in 2021. Single-capsule BQT-containing bismuth, metronidazole and tetracycline-plus a PPI (single-capsule BQT, ScBQT) was the most frequent treatment mode (43%). Schemes that obtained an effectiveness above 90% were the 10-day ScBQT and 14-day BQT using tetracycline plus metronidazole, or amoxicillin plus either clarithromycin or metronidazole. Only ScBQT achieved above 90% cure rates in all the geographical areas studied. Using the ScBQT scheme, adherence, the use of standard or high-dose PPIs, 14-day prescriptions and the use of BQT as first-line treatment were significantly associated with higher mITT effectiveness., Conclusion: The use of BQT increased notably in Europe over the study period. A 10-day ScBQT was the scheme that most consistently achieved optimal effectiveness., Trial Registration Number: NCT02328131., Competing Interests: Competing interests: XC has received research grants and fees for lectures from Allergan. JPG has served as speaker, consultant and advisory member for or has received research funding from Mayoly Spindler, Allergan, Diasorin, Richen, Biocodex and Juvisé. OPN received research funding from Allergan, Mayoly Spindler, Richen, Biocodex and Juvisé. DSB served as a lecturer for Astellas, AstraZeneca, KRKA and Abbott. FM is a consultant for PHATHOM, DaVoltera and has received grants from Allergan, bioMerieux and Mobidiag. The remaining authors declare no conflict of interest., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
Published: 2024
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41. Role of compliance in Helicobacter pylori eradication treatment: Results of the European Registry on H. pylori management.

Author: Huguet JM, Ferrer-Barceló L, Suárez P, Barcelo-Cerda S, Sempere J, Saracino IM, Fiorini G, Vaira D, Pérez-Aísa Á, Jonaitis L, Tepes B, Castro-Fernandez M, Pabón-Carrasco M, Keco-Huerga A, Voynovan I, Lucendo AJ, Lanas Á, Martínez-Domínguez SJ, Alfaro Almajano E, Rodrigo L, Vologzanina L, Bordin DS, Gasbarrini A, Babayeva G, Lerang F, Leja M, Kupčinskas J, Rokkas T, Marcos-Pinto R, Meštrović A, Gridnyev O, Phull PS, Smith SM, Boltin D, Buzás GM, Kral J, Şimşek H, Matysiak-Budnik T, Milivojevic V, Marlicz W, Venerito M, Boyanova L, Doulberis M, Capelle LG, Cano-Català A, Moreira L, Nyssen OP, Mégraud F, O'Morain C, and Gisbert JP
Subjects: Humans, Male, Female, Middle Aged, Prospective Studies, Europe, Adult, Treatment Outcome, Clarithromycin therapeutic use, Aged, Dyspepsia drug therapy, Dyspepsia microbiology, Metronidazole therapeutic use, Metronidazole administration & dosage, Bismuth therapeutic use, Bismuth administration & dosage, Bismuth adverse effects, Helicobacter Infections drug therapy, Helicobacter pylori drug effects, Medication Adherence statistics & numerical data, Proton Pump Inhibitors therapeutic use, Proton Pump Inhibitors administration & dosage, Registries, Anti-Bacterial Agents therapeutic use, Anti-Bacterial Agents adverse effects, Drug Therapy, Combination, Amoxicillin therapeutic use, Amoxicillin administration & dosage
Abstract: Background: Adherence to Helicobacter pylori (H. pylori) eradication treatment is a cornerstone for achieving adequate treatment efficacy., Objective: To determine which factors influence compliance with treatment., Methods: A systematic prospective non-interventional registry (Hp-EuReg) of the clinical practice of European gastroenterologists. Compliance was considered adequate if ≥90% drug intake. Data were collected until September 2021 using the AEG-REDCap e-CRF and were subjected to quality control. Modified intention-to-treat analyses were performed. Multivariate analysis carried out the factors associated with the effectiveness of treatment and compliance., Results: Compliance was inadequate in 646 (1.7%) of 38,698 patients. The non-compliance rate was higher in patients prescribed longer regimens (10-, 14-days) and rescue treatments, patients with uninvestigated dyspepsia/functional dyspepsia, and patients reporting adverse effects. Prevalence of non-adherence was lower for first-line treatment than for rescue treatment (1.5% vs. 2.2%; p < 0.001). Differences in non-adherence in the three most frequent first-line treatments were shown: 1.1% with proton pump inhibitor + clarithromycin + amoxicillin; 2.3% with proton pump inhibitor clarithromycin amoxicillin metronidazole; and 1.8% with bismuth quadruple therapy. These treatments were significantly more effective in compliant than in non-compliant patients: 86% versus 44%, 90% versus 71%, and 93% versus 64%, respectively (p < 0.001). In the multivariate analysis, the variable most significantly associated with higher effectiveness was adequate compliance (odds ratio, 6.3 [95%CI, 5.2-7.7]; p < 0.001)., Conclusions: Compliance with Helicobacter pylori eradication treatment is very good. Factors associated with poor compliance include uninvestigated/functional dyspepsia, rescue-treatment, prolonged treatment regimens, the presence of adverse events, and the use of non-bismuth sequential and concomitant treatment. Adequate treatment compliance was the variable most closely associated with successful eradication., (© 2024 The Authors. United European Gastroenterology Journal published by Wiley Periodicals LLC on behalf of United European Gastroenterology.)
Published: 2024
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42. Effectiveness of Helicobacter pylori Treatments According to Antibiotic Resistance.

Author: Bujanda L, Nyssen OP, Ramos J, Bordin DS, Tepes B, Perez-Aisa A, Pavoni M, Castro-Fernandez M, Lerang F, Leja M, Rodrigo L, Rokkas T, Kupcinskas J, Jonaitis L, Shvets O, Gasbarrini A, Simsek H, Phull PS, Buzás GM, Machado JC, Boltin D, Boyanova L, Tonkić A, Marlicz W, Venerito M, Vologzanina L, Fadieienko GD, Fiorini G, Resina E, Muñoz R, Cano-Català A, Puig I, García-Morales N, Hernández L, Moreira L, Megraud F, Morain CO, Montes M, and Gisbert JP
Subjects: Adult, Humans, Anti-Bacterial Agents pharmacology, Bismuth pharmacology, Clarithromycin pharmacology, Drug Resistance, Microbial, Drug Therapy, Combination, Levofloxacin pharmacology, Metronidazole pharmacology, Prospective Studies, Tinidazole pharmacology, Helicobacter Infections drug therapy, Helicobacter Infections microbiology, Helicobacter pylori
Abstract: Introduction: Antibiotic resistance is one of the main factors that determine the efficacy of treatments to eradicate Helicobacter pylori infection. Our aim was to evaluate the effectiveness of first-line and rescue treatments against H. pylori in Europe according to antibiotics resistance., Methods: Prospective, multicenter, international registry on the management of H. pylori (European Registry on H. pylori Management). All infected and culture-diagnosed adult patients registered in the Spanish Association of Gastroenterology-Research Electronic Data Capture from 2013 to 2021 were included., Results: A total of 2,852 naive patients with culture results were analyzed. Resistance to clarithromycin, metronidazole, and quinolones was 22%, 27%, and 18%, respectively. The most effective treatment, regardless of resistance, were the 3-in-1 single capsule with bismuth, metronidazole, and tetracycline (91%) and the quadruple with bismuth, offering optimal cure rates even in the presence of bacterial resistance to clarithromycin or metronidazole. The concomitant regimen with tinidazole achieved an eradication rate of 99% (90/91) vs 84% (90/107) with metronidazole. Triple schedules, sequential, or concomitant regimen with metronidazole did not achieve optimal results. A total of 1,118 non-naive patients were analyzed. Resistance to clarithromycin, metronidazole, and quinolones was 49%, 41%, and 24%, respectively. The 3-in-1 single capsule (87%) and the triple therapy with levofloxacin (85%) were the only ones that provided encouraging results., Discussion: In regions where the antibiotic resistance rate of H. pylori is high, eradication treatment with the 3-in-1 single capsule, the quadruple with bismuth, and concomitant with tinidazole are the best options in naive patients. In non-naive patients, the 3-in-1 single capsule and the triple therapy with levofloxacin provided encouraging results., (Copyright © 2023 by The American College of Gastroenterology.)
Published: 2024
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43. Author Correction: Comparison of the management of Helicobacter pylori infection between the older and younger European populations.

Author: Jonaitis P, Nyssen OP, Saracino IM, Fiorini G, Vaira D, Pérez-Aísa Á, Tepes B, Castro-Fernandez M, Pabón-Carrasco M, Keco-Huerga A, Voynovan I, Lucendo AJ, Lanas Á, Martínez-Domínguez SJ, Almajano EA, Rodrigo L, Vologzanina L, Brglez Jurecic N, Denkovski M, Bujanda L, Mahmudov U, Leja M, Lerang F, Babayeva G, Bordin DS, Gasbarrini A, Kupcinskas J, Gridnyev O, Rokkas T, Marcos-Pinto R, Phull PS, Smith SM, Tonkić A, Boltin D, Buzás GM, Šembera Š, Şimşek H, Matysiak-Budnik T, Milivojevic V, Marlicz W, Venerito M, Boyanova L, Doulberis M, Capelle LG, Cano-Català A, Moreira L, Mégraud F, O'Morain C, Gisbert JP, and Jonaitis L
Published: 2023
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44. Bismuth quadruple three-in-one single capsule three times a day increases effectiveness compared with the usual four times a day schedule: results from the European Registry on Helicobacter pylori Management (Hp-EuReg).

Author: Pérez-Aisa Á, Nyssen OP, Keco-Huerga A, Rodrigo L, Lucendo AJ, Gomez-Rodriguez BJ, Ortuño J, Perona M, Huguet JM, Núñez O, Fernandez-Salazar L, Barrio J, Lanas A, Iyo E, Romero PM, Fernández-Bermejo M, Gomez B, Garre A, Gomez-Camarero J, Lamuela LJ, Campillo A, de la Peña-Negro L, Dominguez Cajal M, Bujanda L, Burgos-Santamaría D, Bermejo F, González-Carrera V, Pajares R, Notari PA, Tejedor-Tejada J, Planella M, Jiménez I, Lázaro YA, Cuadrado-Lavín A, Pérez-Martínez I, Amorena E, Gonzalez-Santiago JM, Angueira T, Flores V, Martínez-Domínguez SJ, Pabón-Carrasco M, Velayos B, Algaba A, Ramírez C, Almajano EA, Castro-Fernandez M, Alcaide N, Sanz Segura P, Cano-Català A, García-Morales N, Moreira L, Mégraud F, O'Morain C, Calvet X, and Gisbert JP
Subjects: Adult, Humans, Female, Middle Aged, Male, Bismuth adverse effects, Anti-Bacterial Agents therapeutic use, Drug Therapy, Combination, Metronidazole therapeutic use, Proton Pump Inhibitors, Registries, Amoxicillin therapeutic use, Helicobacter Infections drug therapy, Helicobacter pylori
Abstract: Background: The recommended schedule for single capsule bismuth quadruple therapy (scBQT, Pylera) includes a proton pump inhibitor (PPI) two times a day and three scBQT capsules four times a day. Four times a day treatments are inconvenient and reduce adherence. In contrast, adherence improves with three times a day schedules. In clinical practice, many gastroenterologists use four capsule scBQT three times a day. However, the effectiveness and safety of this latter approach remain uncertain., Aim: To assess the effectiveness and safety of scBQT administered three times a day in the patients included in the European Registry on Helicobacter pylori Management (Hp-EuReg)., Methods: All Spanish adult patients registered in the Asociación Española de Gastroenterología Research Electronic Data Capture (REDCap) database from June 2013 to March 2021 receiving 10-day scBQT were analysed. Modified intention-to-treat effectiveness, adherence and the safety of scBQT given three times a day were calculated and compared with the four times a day schedule. A multivariate analysis was performed to determine independent factors predicting cure of the infection., Results: Of the 3712 cases, 2516 (68%) were four times a day and 1196 (32%) three times a day. Mean age was 51 years, 63% were women and 15% had a peptic ulcer. The three times a day schedule showed significantly better overall cure rates than four times a day (1047/1112, 94%; 95% CI 92.7 to 95.6 vs 2207/2423, 91%; 95% CI 89.9 to 92.2, respectively, p=0.002). Adherence and safety data were similar for both regimens. In the multivariate analysis, three times a day dosage, first-line therapy, use of standard or high-dose PPIs and adherence over 90% were significantly associated with cure of the infection., Conclusions: ScBQT prescribed three times a day was more effective than the traditional four times a day schedule. No differences were observed in treatment adherence or safety., Competing Interests: Competing interests: XC has received research grants and fees for lectures from Allergan. JPG has served as speaker, consultant and advisory member for or has received research funding from Mayoly Spindler, Allergan, Diasorin, Gebro Pharma and Richen. OPN received research funding from Allergan and Mayoly Spindler. Dr Bordin served as a lecturer for Astellas, AstraZeneca, KRKA, and Abbott. FM is a consultant for PHATHOM and DaVoltera and has received grants from Allergan, bioMerieux and Mobidiag. The remaining authors declare no conflict of interest., (© Author(s) (or their employer(s)) 2023. No commercial re-use. See rights and permissions. Published by BMJ.)
Published: 2023
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45. Comparison of the management of Helicobacter pylori infection between the older and younger European populations.

Author: Jonaitis P, Nyssen OP, Saracino IM, Fiorini G, Vaira D, Pérez-Aísa Á, Tepes B, Castro-Fernandez M, Pabón-Carrasco M, Keco-Huerga A, Voynovan I, Lucendo AJ, Lanas Á, Martínez-Domínguez SJ, Almajano EA, Rodrigo L, Vologzanina L, Brglez Jurecic N, Denkovski M, Bujanda L, Mahmudov U, Leja M, Lerang F, Babayeva G, Bordin DS, Gasbarrini A, Kupcinskas J, Gridnyev O, Rokkas T, Marcos-Pinto R, Phull PS, Smith SM, Tonkić A, Boltin D, Buzás GM, Šembera Š, Şimşek H, Matysiak-Budnik T, Milivojevic V, Marlicz W, Venerito M, Boyanova L, Doulberis M, Capelle LG, Cano-Català A, Moreira L, Mégraud F, O'Morain C, Gisbert JP, and Jonaitis L
Subjects: Humans, Aged, Anti-Bacterial Agents adverse effects, Bismuth therapeutic use, Drug Therapy, Combination, Proton Pump Inhibitors adverse effects, Penicillins therapeutic use, Treatment Outcome, Helicobacter Infections drug therapy, Helicobacter Infections epidemiology, Helicobacter pylori, Hypersensitivity drug therapy
Abstract: The prevalence of Helicobacter pylori remains high in the older population. Specific age-related peculiarities may impact the outcomes of H. pylori treatment. The aim of the study was to evaluate the diagnostics and effectiveness of H. pylori eradication between the younger and older European populations. "European Registry on H. pylori Management (Hp-EuReg)" data from 2013 to 2022 were analyzed. Patients were divided into older (≥ 60 years) and younger (18-59 years) groups. Modified intention-to-treat (mITT) and per-protocol (PP) analysis was performed. 49,461 patients included of which 14,467 (29%) were older-aged. Concomitant medications and penicillin allergy were more frequent among the older patients. Differences between younger and older populations were observed in treatment duration in first-line treatment and in proton pump inhibitors (PPIs) doses in second-line treatment. The overall incidence of adverse events was lower in the older adults group. The overall first-line treatment mITT effectiveness was 88% in younger and 90% in the older patients (p < 0.05). The overall second-line mITT treatment effectiveness was 84% in both groups. The effectiveness of the most frequent first- and second-line triple therapies was suboptimal (< 90%) in both groups. Optimal efficacy (≥ 90%) was achieved by using bismuth and non-bismuth-based quadruple therapies. In conclusion, the approach to the diagnostics and treatment of H. pylori infection did not generally differ between younger and older patients. Main differences were reported in the concurrent medications, allergy to penicillin and adverse events both in first- and second-line treatment. Optimal effectiveness rates were mostly achieved by using bismuth and non-bismuth-based quadruple therapies. No clinically relevant differences in the effectiveness between the age groups were observed., (© 2023. Springer Nature Limited.)
Published: 2023
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46. Quality, Usability, and Effectiveness of mHealth Apps and the Role of Artificial Intelligence: Current Scenario and Challenges.

Author: Deniz-Garcia A, Fabelo H, Rodriguez-Almeida AJ, Zamora-Zamorano G, Castro-Fernandez M, Alberiche Ruano MDP, Solvoll T, Granja C, Schopf TR, Callico GM, Soguero-Ruiz C, and Wägner AM
Subjects: Humans, Artificial Intelligence, Reproducibility of Results, Risk Factors, Mobile Applications, Telemedicine methods
Abstract: The use of artificial intelligence (AI) and big data in medicine has increased in recent years. Indeed, the use of AI in mobile health (mHealth) apps could considerably assist both individuals and health care professionals in the prevention and management of chronic diseases, in a person-centered manner. Nonetheless, there are several challenges that must be overcome to provide high-quality, usable, and effective mHealth apps. Here, we review the rationale and guidelines for the implementation of mHealth apps and the challenges regarding quality, usability, and user engagement and behavior change, with a special focus on the prevention and management of noncommunicable diseases. We suggest that a cocreation-based framework is the best method to address these challenges. Finally, we describe the current and future roles of AI in improving personalized medicine and provide recommendations for developing AI-based mHealth apps. We conclude that the implementation of AI and mHealth apps for routine clinical practice and remote health care will not be feasible until we overcome the main challenges regarding data privacy and security, quality assessment, and the reproducibility and uncertainty of AI results. Moreover, there is a lack of both standardized methods to measure the clinical outcomes of mHealth apps and techniques to encourage user engagement and behavior changes in the long term. We expect that in the near future, these obstacles will be overcome and that the ongoing European project, Watching the risk factors (WARIFA), will provide considerable advances in the implementation of AI-based mHealth apps for disease prevention and health promotion., (©Alejandro Deniz-Garcia, Himar Fabelo, Antonio J Rodriguez-Almeida, Garlene Zamora-Zamorano, Maria Castro-Fernandez, Maria del Pino Alberiche Ruano, Terje Solvoll, Conceição Granja, Thomas Roger Schopf, Gustavo M Callico, Cristina Soguero-Ruiz, Ana M Wägner, WARIFA Consortium. Originally published in the Journal of Medical Internet Research (https://www.jmir.org), 04.05.2023.)
Published: 2023
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47. Empirical rescue treatment of Helicobacter pylori infection in third and subsequent lines: 8-year experience in 2144 patients from the European Registry on H. pylori management (Hp-EuReg).

Author: Burgos-Santamaría D, Nyssen OP, Gasbarrini A, Vaira D, Pérez-Aisa Á, Rodrigo L, Pellicano R, Keco-Huerga A, Pabón-Carrasco M, Castro-Fernandez M, Boltin D, Barrio J, Phull P, Kupcinskas J, Jonaitis L, Ortiz-Polo I, Tepes B, Lucendo AJ, Huguet JM, Areia M, Jurecic NB, Denkovski M, Bujanda L, Ramos-San Román J, Cuadrado-Lavín A, Gomez-Camarero J, Jiménez Moreno MA, Lanas A, Martinez-Dominguez SJ, Alfaro E, Marcos-Pinto R, Milivojevic V, Rokkas T, Leja M, Smith S, Tonkić A, Buzás GM, Doulberis M, Venerito M, Lerang F, Bordin DS, Lamy V, Capelle LG, Marlicz W, Dobru D, Gridnyev O, Puig I, Mégraud F, O'Morain C, and Gisbert JP
Abstract: Objective: To evaluate the use, effectiveness and safety of Helicobacter pylori empirical rescue therapy in third and subsequent treatment lines in Europe., Design: International, prospective, non-interventional registry of the clinical practice of European gastroenterologists. Data were collected and quality reviewed until October 2021 at Asociación Española de Gastroenterología-Research Electronic Data Capture. All cases with three or more empirical eradication attempts were assessed for effectiveness by modified intention-to-treat and per-protocol analysis., Results: Overall, 2144 treatments were included: 1519, 439, 145 and 41 cases from third, fourth, fifth and sixth treatment lines, respectively. Sixty different therapies were used; the 15 most frequently prescribed encompassed >90% of cases. Overall effectiveness remained <90% in all therapies. Optimised treatments achieved a higher eradication rate than non-optimised (78% vs 67%, p<0.0001). From 2017 to 2021, only 44% of treatments other than 10-day single-capsule therapy used high proton-pump inhibitor doses and lasted ≥14 days. Quadruple therapy containing metronidazole, tetracycline and bismuth achieved optimal eradication rates only when prescribed as third-line treatment, either as 10-day single-capsule therapy (87%) or as 14-day traditional therapy with tetracycline hydrochloride (95%). Triple amoxicillin-levofloxacin therapy achieved 90% effectiveness in Eastern Europe only or when optimised. The overall incidence of adverse events was 31%., Conclusion: Empirical rescue treatment in third and subsequent lines achieved suboptimal effectiveness in most European regions. Only quadruple bismuth-metronidazole-tetracycline (10-day single-capsule or 14-day traditional scheme) and triple amoxicillin-levofloxacin therapies reached acceptable outcomes in some settings. Compliance with empirical therapy optimisation principles is still poor 5 years after clinical practice guidelines update., Trial Registration Number: NCT02328131., Competing Interests: Competing interests: OPN has received research funding from Mayoly and Allergan. JPG has served as speaker, consultant and advisory member for or has received research funding from Mayoly, Allergan, Diasorin, Gebro Pharma and Richen. MC-F has received retribution from Allergan for formative actions. AP-A has received retribution from Allergan and Mylan for formative actions. Laimas Jonaitis has served as speaker for KRKA. AL has served as a consultant to Bayer., (© Author(s) (or their employer(s)) 2022. No commercial re-use. See rights and permissions. Published by BMJ.)
Published: 2022
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48. Adverse Event Profile During the Treatment of Helicobacter pylori: A Real-World Experience of 22,000 Patients From the European Registry on H. pylori Management (Hp-EuReg).

Author: Nyssen OP, Perez-Aisa A, Tepes B, Castro-Fernandez M, Kupcinskas J, Jonaitis L, Bujanda L, Lucendo A, Jurecic NB, Perez-Lasala J, Shvets O, Fadeenko G, Huguet JM, Kikec Z, Bordin D, Voynovan I, Leja M, Machado JC, Areia M, Fernandez-Salazar L, Rodrigo L, Alekseenko S, Barrio J, Ortuño J, Perona M, Vologzhanina L, Romero PM, Zaytsev O, Rokkas T, Georgopoulos S, Pellicano R, Buzas GM, Modolell I, Gomez Rodriguez BJ, Simsek I, Simsek C, Lafuente MR, Ilchishina T, Camarero JG, Dominguez-Cajal M, Ntouli V, Dekhnich NN, Phull P, Nuñez O, Lerang F, Venerito M, Heluwaert F, Tonkic A, Caldas M, Puig I, Megraud F, O'Morain C, and Gisbert JP
Subjects: Anti-Bacterial Agents therapeutic use, Bismuth therapeutic use, Drug Therapy, Combination, Europe epidemiology, Female, Helicobacter Infections epidemiology, Helicobacter pylori, Humans, Incidence, Male, Middle Aged, Proton Pump Inhibitors therapeutic use, Registries, Anti-Bacterial Agents adverse effects, Bismuth adverse effects, Drug-Related Side Effects and Adverse Reactions epidemiology, Helicobacter Infections drug therapy, Proton Pump Inhibitors adverse effects
Abstract: Introduction: The safety of Helicobacter pylori eradication treatments and to what extent adverse events (AEs) influence therapeutic compliance in clinical practice are hardly known. Our aim was to assess the frequency, type, intensity, and duration of AEs, and their impact on compliance, for the most frequently used treatments in the "European Registry on Helicobacter pylori management.", Methods: Systematic prospective noninterventional registry of the clinical practice of European gastroenterologists (27 countries, 300 investigators) on the management of H. pylori infection in routine clinical practice. All prescribed eradication treatments and their corresponding safety profile were recorded. AEs were classified depending on the intensity of symptoms as mild/moderate/severe and as serious AEs. All data were subject to quality control., Results: The different treatments prescribed to 22,492 patients caused at least 1 AE in 23% of the cases; the classic bismuth-based quadruple therapy was the worst tolerated (37% of AEs). Taste disturbance (7%), diarrhea (7%), nausea (6%), and abdominal pain (3%) were the most frequent AEs. The majority of AEs were mild (57%), 6% were severe, and only 0.08% were serious, with an average duration of 7 days. The treatment compliance rate was 97%. Only 1.3% of the patients discontinued treatment due to AEs. Longer treatment durations were significantly associated with a higher incidence of AEs in standard triple, concomitant, bismuth quadruple, and levofloxacin triple or quadruple therapies., Discussion: Helicobacter pylori eradication treatment frequently induces AEs, although they are usually mild and of limited duration. Their appearance does not interfere significantly with treatment compliance., Competing Interests: The remaining list of authors, their affiliations, contributions and conflicts of interests are listed in Supplementary file 1. Contribution Log, available online at http://links.lww.com/AJG/B961., (Copyright © 2021 by The American College of Gastroenterology.)
Published: 2021
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49. European Registry on Helicobacter pylori management: Single-capsule bismuth quadruple therapy is effective in real-world clinical practice.

Author: Nyssen OP, Perez-Aisa A, Castro-Fernandez M, Pellicano R, Huguet JM, Rodrigo L, Ortuñ J, O, Gomez-Rodriguez BJ, Pinto RM, Areia M, Perona M, Nuñez O, Romano M, Gravina AG, Pozzati L, Fernandez-Bermejo M, Venerito M, Malfertheiner P, Fernanadez-Salazar L, Gasbarrini A, Vaira D, Puig I, Megraud F, O'Morain C, and Gisbert JP
Subjects: Adolescent, Adult, Anti-Bacterial Agents adverse effects, Bismuth adverse effects, Capsules, Drug Combinations, Drug Resistance, Bacterial, Europe, Female, Humans, Intention to Treat Analysis, Male, Medication Adherence, Metronidazole administration & dosage, Metronidazole adverse effects, Middle Aged, Proton Pump Inhibitors adverse effects, Registries, Tetracycline administration & dosage, Tetracycline adverse effects, Young Adult, Anti-Bacterial Agents administration & dosage, Bismuth administration & dosage, Gastrointestinal Diseases drug therapy, Gastrointestinal Diseases microbiology, Helicobacter Infections drug therapy, Helicobacter pylori, Proton Pump Inhibitors administration & dosage
Abstract: Background: There has been resurgence in the use of bismuth quadruple therapy (proton pump inhibitor, bismuth, tetracycline and metronidazole) for treating Helicobacter pylori infection thanks to a three-in-one single-capsule formulation., Objective: To evaluate the effectiveness and safety of the single-capsule bismuth quadruple therapy., Methods: Data were collected in a multicentre, prospective registry of the clinical practice of gastroenterologists on the management of H. pylori infection, where patients were registered at the Asociación Española de Gastroenterologia REDCap database on an electronic case report form until January 2020. Effectiveness by modified intention-to-treat and per-protocol as well as multivariable analysis were performed. Independent factors evaluated were: age, gender, indication, compliance, proton pump inhibitor dose and treatment line., Results: Finally, 2100 patients were prescribed single-capsule bismuth quadruple therapy following the technical sheet (i.e., three capsules every 6 h for 10 days). The majority of these patients were naive (64%), with an average age of 50 years, 64% women and 16% with peptic ulcer. An overall modified intention-to-treat effectiveness of 92% was achieved. Eradication was over 90% in first-line treatment (95% modified intention-to-treat, n = 1166), and this was maintained as a rescue therapy, both in second (89% modified intention-to-treat, n = 375) and subsequent lines of therapy (third to sixth line: 92% modified intention-to-treat, n = 236). Compliance was the factor most closely associated with treatment effectiveness. Adverse events were generally mild to moderate, and 3% of patients reported a severe adverse event, leading to discontinuation of treatment in 1.7% of cases., Conclusions: Single-capsule bismuth quadruple therapy achieved H. pylori eradication in approximately 90% of patients in real-world clinical practice, both as a first-line and rescue treatment, with good compliance and a favourable safety profile., (© 2020 The Authors. United European Gastroenterology Journal published by Wiley Periodicals LLC. on behalf of United European Gastroenterology.)
Published: 2021
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50. European Registry on Helicobacter pylori management (Hp-EuReg): patterns and trends in first-line empirical eradication prescription and outcomes of 5 years and 21 533 patients.

Author: Nyssen OP, Bordin D, Tepes B, Pérez-Aisa Á, Vaira D, Caldas M, Bujanda L, Castro-Fernandez M, Lerang F, Leja M, Rodrigo L, Rokkas T, Kupcinskas L, Pérez-Lasala J, Jonaitis L, Shvets O, Gasbarrini A, Simsek H, Axon ATR, Buzás G, Machado JC, Niv Y, Boyanova L, Goldis A, Lamy V, Tonkic A, Przytulski K, Beglinger C, Venerito M, Bytzer P, Capelle L, Milosavljević T, Milivojevic V, Veijola L, Molina-Infante J, Vologzhanina L, Fadeenko G, Ariño I, Fiorini G, Garre A, Garrido J, F Pérez C, Puig I, Heluwaert F, Megraud F, O'Morain C, and Gisbert JP
Subjects: Adult, Aged, Drug Therapy, Combination, Europe, Female, Humans, Male, Middle Aged, Prospective Studies, Registries, Anti-Bacterial Agents therapeutic use, Helicobacter Infections drug therapy, Helicobacter pylori, Practice Patterns, Physicians' statistics & numerical data, Proton Pump Inhibitors therapeutic use
Abstract: Objective: The best approach for Helicobacter pylori management remains unclear. An audit process is essential to ensure clinical practice is aligned with best standards of care., Design: International multicentre prospective non-interventional registry starting in 2013 aimed to evaluate the decisions and outcomes in H. pylori management by European gastroenterologists. Patients were registered in an e-CRF by AEG-REDCap. Variables included demographics, previous eradication attempts, prescribed treatment, adverse events and outcomes. Data monitoring was performed to ensure data quality. Time-trend and geographical analyses were performed., Results: 30 394 patients from 27 European countries were evaluated and 21 533 (78%) first-line empirical H. pylori treatments were included for analysis. Pretreatment resistance rates were 23% to clarithromycin, 32% to metronidazole and 13% to both. Triple therapy with amoxicillin and clarithromycin was most commonly prescribed (39%), achieving 81.5% modified intention-to-treat eradication rate. Over 90% eradication was obtained only with 10-day bismuth quadruple or 14-day concomitant treatments. Longer treatment duration, higher acid inhibition and compliance were associated with higher eradication rates. Time-trend analysis showed a region-dependent shift in prescriptions including abandoning triple therapies, using higher acid-inhibition and longer treatments, which was associated with an overall effectiveness increase (84%-90%)., Conclusion: Management of H. pylori infection by European gastroenterologists is heterogeneous, suboptimal and discrepant with current recommendations. Only quadruple therapies lasting at least 10 days are able to achieve over 90% eradication rates. European recommendations are being slowly and heterogeneously incorporated into routine clinical practice, which was associated with a corresponding increase in effectiveness., Competing Interests: Competing interests: JPG has served as speaker, consultant and advisory member for or has received research funding from Mayoly, Allergan and Diasorin. OPN has received a research grant from Allergan. JM-I has served as a consultant for Casen Recordati and has received retribution from Allergan for formative actions. MC-F has received retribution from Allergan for formative actions. PB has served as speaker, consultant and advisory member for or has received research funding from Almirall, Allergan and Reckitt Benckiser. APA has received retribution from Allergan and Mylan for formative actions. DSB has served as lecturer for Astellas, AstraZeneca, KRKA and Abbott., (© Author(s) (or their employer(s)) 2021. No commercial re-use. See rights and permissions. Published by BMJ.)
Published: 2021
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