Empirical Second-Line Therapy in 5000 Patients of the European Registry on Helicobacter pylori Management (Hp-EuReg)
2021; Elsevier BV; Volume: 20; Issue: 10 Linguagem: Inglês
10.1016/j.cgh.2021.12.025
ISSN1542-7714
AutoresOlga P. Nyssen, Dino Vaira, Ángeles Pérez Aísa, Luı́s Rodrigo, Manuel Castro‐Fernández, Laimas Virginijus Jonaitis, Bojan Tepeš, Л. Г. Вологжанина, María Caldas, Ángel Lanas, Alfredo J. Lucendo, Luís Bujanda, Juan Ortuño, Jesús Barrio, José María Huguet, Irina Voynovan, Jorge Pérez Lasala, А. С. Сарсенбаева, Luis Fernández‐Salazar, Javier Molina‐Infante, Nataša Brglez Jurečič, Miguel Areia, Antonio Gasbarrini, Juozas Kupčinskas, Д.С. Бордин, Ricardo Marcos‐Pinto, Frode Lerang, Mārcis Leja, György Miklós Buzás, Yaron Niv, Theodore Rokkas, Perminder Phull, Sinéad M. Smith, Oleg Shvets, Marino Venerito, Vladimir Milivojević, İlkay Şımşek, Vincent Lamy, Peter Bytzer, Lyudmila Boyanova, Lumír Kunovský, Christoph Beglinger, Michael Doulberis, Wojciech Marlicz, Adrian Goldiș, Ante Tonkić, Lisette G. Capelle, Ignasi Puig, Françis Mégraud, Colm O Morain, Javier P. Gisbert, Giulia Fiorinni, Ilaria Maria Saracino, Manuel Pabón‐Carrasco, Alma Keco Huerga, Enrique Alfaro Almajano, Samuel Jesús Martínez- Domínguez, Horacio Alonso Galán, Benito Velayos, Carmen Dueñas Sadornil, Jose Maria Botargues Bote, Pedro L. Gonzalez-Cordero, Miguel Areia, Blas José Gómez Rodríguez, Rinaldo Pellicano, Óscar Núñez Martínez, Francesco Franceschi, С. А. Алексеенко, Mónica Perona, Rustam A. Abdulkhakov, Manuel Domínguez‐Cajal, Pedro Almela Notari, Judith Gómez Camarero, Manuel Jimenez Moreno, Alicia Algaba, Fernando Bermejo, Jose Maria Botargues Bote, Javier Tejedor‐Tejada, Elida Oblitas Susanibar, Doron Boltin, Sotirios D. Georgopoulos, Colm O’Morain, Asghar Qasim, Ian Beales, Н. В. Бакулина, Galina Fadeenko, Peter Malfertheiner, Rosa Rosania, Tatiana Ilchishina, Pavel Bogomolov, И. Г. Бакулин, O V Zaytsev, Antonietta Gerarda Gravina, Marco Romano, Alfredo Di Leo, Giuseppe Losurdo, Ludmila Grigorieva, Pedro Delgado‐Guillena, Marinko Marušić, Dragan Jurčić, Н. Н. Дехнич, Eduardo Iyo, Luisa Carmen de la Peña Negro, Н. В. Барышникова, Natalia Bakanova, Cem Şimşek, Cem Şimşek, Oleksiy Gridnyev, Miguel Fernández‐Bermejo, Teresa Angueira, Rafael Ruíz-Zorrilla López, Bárbara Gómez, Mila Kovacheva-Slavova, Adi Lahat, Javier Alcedo, Ana Campillo, Л Н Белоусова, Ramón Pajares Villarroya, Neven Ljubičić, Marko Nikolić, Jesús M. González‐Santiago, Diego Burgos Santamaría, Anna Pakhomova, Izabela Sekulic-Spasic, Matteo Ghisa, Fabio Farinati, Сабир Сагдати, Nikola Panić, Frédéric Heluwaert, Edurne Amorena, Leticia Moreira, Glòria Fernández‐Esparrach, Ekaterina Yuryevna Plotnikova, Michał Kukla, Victor Kamburov, Luis Javier Lamuela Calvo, Ivan Ranković, Antonio Cuadrado Lavín, Yolanda Arguedas Lázaro, Victor Gonzalez Carrera Agnieszka Dobrowolska, Piotr Eder, А. Г. Кононова,
Tópico(s)Gastroesophageal reflux and treatments
ResumoBackground & 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, non-interventional 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. 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. This international, multicenter, prospective, non-interventional 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. 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. 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.
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