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. 2023 Nov;72(11):2031-2038.
doi: 10.1136/gutjnl-2022-329259. Epub 2023 Jul 19.

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)

Ángeles Pérez-Aisa #  1   2 , Olga P Nyssen #  3   4 , Alma Keco-Huerga  5 , Luís Rodrigo  6 , Alfredo J Lucendo  4   7   8   9 , Blas J Gomez-Rodriguez  10 , Juan Ortuño  11 , Mónica Perona  12 , José María Huguet  13 , Oscar Núñez  14 , Luis Fernandez-Salazar  15   16 , Jesus Barrio  17 , Angel Lanas  18   19   20 , Eduardo Iyo  21 , Pilar Mata Romero  22 , Miguel Fernández-Bermejo  23 , Barbara Gomez  24 , Ana Garre  3   4 , Judith Gomez-Camarero  25 , Luis Javier Lamuela  18   26 , Ana Campillo  27 , Luisa de la Peña-Negro  28 , Manuel Dominguez Cajal  29 , Luis Bujanda  4   30 , Diego Burgos-Santamaría  31 , Fernando Bermejo  32   33 , Víctor González-Carrera  34 , Ramón Pajares  35   36 , Pedro Almela Notari  37 , Javier Tejedor-Tejada  38 , Montserrat Planella  39 , Itxaso Jiménez  40 , Yolanda Arguedas Lázaro  41 , Antonio Cuadrado-Lavín  42 , Isabel Pérez-Martínez  43 , Edurne Amorena  44 , Jesús M Gonzalez-Santiago  4   45 , Teresa Angueira  7 , Virginia Flores  46 , Samuel J Martínez-Domínguez  18   19   20 , Manuel Pabón-Carrasco  5 , Benito Velayos  15   16 , Alicia Algaba  32   33 , Consuelo Ramírez  39 , Enrique Alfaro Almajano  18   19   20 , Manuel Castro-Fernandez  5 , Noelia Alcaide  15   16 , Patricia Sanz Segura  41 , Anna Cano-Català  47 , Natalia García-Morales  48   49 , Leticia Moreira  50   51 , Francis Mégraud  52 , Colm O'Morain  53 , Xavier Calvet  54   55 , Javier P Gisbert  3   4
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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)

Ángeles Pérez-Aisa et al. Gut. 2023 Nov.

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.

Keywords: helicobacter pylori.

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Conflict of interest statement

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.

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