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

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 si...

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Autores principales: 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.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8259339/
https://www.ncbi.nlm.nih.gov/pubmed/33176617
http://dx.doi.org/10.1177/2050640620972615
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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.
author_facet 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.
author_sort Nyssen, Olga P.
collection PubMed
description 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.
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spelling pubmed-82593392021-07-12 European Registry on Helicobacter pylori management: Single‐capsule bismuth quadruple therapy is effective in real‐world clinical practice 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. United European Gastroenterol J Neurogastroenterology 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. John Wiley and Sons Inc. 2021-02-11 /pmc/articles/PMC8259339/ /pubmed/33176617 http://dx.doi.org/10.1177/2050640620972615 Text en © 2020 The Authors. United European Gastroenterology Journal published by Wiley Periodicals LLC. on behalf of United European Gastroenterology. https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc-nd/4.0/ (https://creativecommons.org/licenses/by-nc-nd/4.0/) License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made.
spellingShingle Neurogastroenterology
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.
European Registry on Helicobacter pylori management: Single‐capsule bismuth quadruple therapy is effective in real‐world clinical practice
title European Registry on Helicobacter pylori management: Single‐capsule bismuth quadruple therapy is effective in real‐world clinical practice
title_full European Registry on Helicobacter pylori management: Single‐capsule bismuth quadruple therapy is effective in real‐world clinical practice
title_fullStr European Registry on Helicobacter pylori management: Single‐capsule bismuth quadruple therapy is effective in real‐world clinical practice
title_full_unstemmed European Registry on Helicobacter pylori management: Single‐capsule bismuth quadruple therapy is effective in real‐world clinical practice
title_short European Registry on Helicobacter pylori management: Single‐capsule bismuth quadruple therapy is effective in real‐world clinical practice
title_sort european registry on helicobacter pylori management: single‐capsule bismuth quadruple therapy is effective in real‐world clinical practice
topic Neurogastroenterology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8259339/
https://www.ncbi.nlm.nih.gov/pubmed/33176617
http://dx.doi.org/10.1177/2050640620972615
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