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1. 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

3. 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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