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EFFECTIVENESS AND SAFETY OF FIRST-LINE EMPIRICAL NON-BISMUTH CONCOMITANT THERAPY VERSUS SINGLE-CAPSULE BISMUTH QUADRUPLE THERAPIES IN SPAIN: ANALYSIS OF 12,000 PATIENTS FROM THE EUROPEAN REGISTRY ON HELICOBACTER PYLORI MANAGEMENT (HP-EUREG)

Olga P. Nyssen 1, Nuria Montes 2, Ángeles Pérez-Aísa 3, Samuel J Martínez-Domínguez 4, Luis Ricardo Rodrigo Sáez 5, Alfredo J. Lucendo 6, Jose Maria Huguet 7, Javier Tejedor-Tejada 8, Ana Garre 1, Luis Bujanda Fernández de Piérola 9, Manuel Pabon-Carrasco 10, Manuel Castro-Fernández 10, Monica Perona 11, Oscar Núñez Martínez 12, Blas José Gómez-Rodríguez 13, Antonio Moreno 14, M. Soledad Marcos 15, Jesús Barrio 16, Fernando Bermejo 17, Judith Gomez-Camarero 18, Alma Keco-Huerga 10, Montserrat Planella de Rubinat 19, Miguel Fernandez-Bermejo 20, Eduardo Iyo 21, Pilar Mata-Romero 22, D. Martin-Holgado 22, Ramón Pajares Villarroya 23, VIRGINIA FLORES 24, Ana Pozo 25, B. Velayos 26, Sheyla Montori 27, Noelia Alcaide 26, T. Angueira 28, Eva Barreiro Alonso 29, Luis Fernández-Salazar 26, Antonio Cuadrado 30, ISABEL PEREZ VALLE 31, Benito Hermida Pérez 32, Mónica Sánchez Alonso 33, Pilar Pazo Mejide 34, Manuel Jiménez-Moreno 35, Elizabeth Barba 36, Eduardo Albéniz-Arbizu 27, Luis Hernández Villalba 35, Anna Cano Català 37, Pablo Parra 1, Leticia Moreira Ruiz 38, Francis Mégraud 39, Colm O'Morain 40, Javier P. Gisbert 1

Affiliations

1 Department of Gastroenterology, Hospital Universitario de La Princesa, IIS-Princesa, Universidad Autónoma de Madrid (UAM), and Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Madrid, Spain

2 Unidad de Metodología, IIS-Princesa; Servicio de Reumatología, Hospital Universitario de La Princesa; Plant Physiology, Pharmaceutical and Health Sciences Department, Faculty of Pharmacy, Universidad San Pablo-CEU, CEU-Universities, Boadilla del Monte, Sp

3 Department of Gastroenterology, Hospital Universitario Costa del Sol, Redes de Investigación Cooperativa Orientada a Resultados en Salud (RICORS), Marbella, Spain

4 Department of Gastroenterology, Hospital Clínico Universitario Lozano Blesa, IIS Aragón, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Zaragoza, Spain

5 Department of Gastroenterology, Universidad de Oviedo, Oviedo, Spain

6 Department of Gastroenterology, Hospital General de Tomelloso, IIS-Princesa, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Tomelloso, Spain

7 Department of Gastroenterology, Hospital General Universitario de Valencia, Valencia, Spain

8 Department of Gastroenterology, Hospital Universitario de Cabueñes, Gijón, Spain

9 Department of Gastroenterology, Biodonostia Health Research Institute, Department of Medicine, Universidad del País Vasco (UPV/EHU), Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), San Sebastián, Spain

10 Department of Gastroenterology, Hospital Universitario Virgen de Valme, Sevilla, Spain

11 Department of Gastroenterology, Hospital Quirón Marbella, Marbella, Spain

12 Department of Gastroenterology, Hospital Universitario Sanitas La Moraleja, Madrid, Spain

13 Department of Gastroenterology, Hospital Universitario Virgen Macarena, Sevilla, Spain

14 Department of Gastroenterology, Hospital Universitario Virgen del Rocío, Sevilla, Spain

15 Department of Gastroenterology, Hospital 12 de Octubre, Madrid, Spain

16 Department of Gastroenterology, Hospital Universitario Río Hortega, Gerencia Regional de Salud de Castilla y León (SACYL), Valladolid, Spain

17 Department of Gastroenterology, Hospital Universitario de Fuenlabrada, Fuenlabrada, Spain

18 Department of Gastroenterology, Hospital Universitario de Burgos, Burgos, Spain

19 Department of Gastroenterology, Hospital Universitari Arnau de Vilanova, Institut de Recerca Biomèdica de Lleida (IRBLL), Lleida, Spain

20 Hospital Parque San Francisco, Cáceres, Spain

21 Department of Gastroenterology, Hospital Comarcal de Inca, Inca, Spain

22 Department of Gastroenterology, Hospital Universitario de Cáceres, Cáceres, Spain

23 Department of Gastroenterology, Hospital Universitario Infanta Sofía, San Sebastián de los Reyes, Spain

24 Department of Gastroenterology, Hospital General Universitario Gregorio Marañón, Madrid, Spain

25 Department of Gastroenterology, Hospital Arnau Vilanova-Lliria, Valencia, Spain

26 Department of Gastroenterology, Hospital Clínico de Valladolid, Valladolid, Spain

27 Department of Gastroenterology, Hospital Universitario de Navarra, Navarrabiomed, Universidad Pública de Navarra, Pamplona, Spain

28 Department of Gastroenterology, Hospital General de Tomelloso, Tomelloso, Spain

29 Department of Gastroenterology, Hospital Central de Asturias, Department of Pharmacology, Instituto de Investigación Sanitaria del Principado de Asturias (ISPA), Oviedo, Spain

30 Gastroenterology and Hepatology Department, Marqués de Valdecilla University Hospital, Clinical and Translational Research in Digestive Diseases, Valdecilla Research Institute (IDIVAL), Santander, Spain

31 Department of Gastroenterology, Hospital Central de Asturias, Oviedo, Spain

32 Department of Gastroenterology, Hospital Valle del Nalón, Langreo, Spain

33 Department of Gastroenterology, Hospital Universitario Santa Bárbara, Puertollano, Spain

34 Department of Gastroenterology, Hospital Universitario de Cruces, Barakaldo, Spain

35 Department of Gastroenterology, Hospital Santos Reyes, Aranda de Duero, Spain

36 Department of Gastroenterology, Neurogastroenterology and Motility Unit, Hospital Clinic de Barcelona, University of Barcelona, Barcelona, Spain

37 Gastrointestinal Oncology, Endoscopy and Surgery (GOES) research group, Althaia Xarxa Assistencial Universitària de Manresa, Institut de Recerca i Innovació en Ciències de la Vida i de la Salut de la Catalunya Central (IRIS-CC), Manresa, Spain

38 Department of Gastroenterology, Hospital Clínic de Barcelona, Centro de Investigación Biomédica en Red en Enfermedades Hepáticas y Digestivas (CIBERehd), Institut d’Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), University of Barcelona, Barcelon

39 INSERM U1312, Université de Bordeaux, Bordeaux, France

40 School of Medicine, Trinity College Dublin, Dublin, Ireland

Summary

AI Generated

In a Spanish registry study of 11,720 treatment-naïve H. pylori patients, bismuth-containing quadruple single-capsule therapy achieved higher eradication rates than non-bismuth concomitant therapy.

Bismuth quadruple single-capsule therapy (10 days) achieved 93% mITT eradication effectiveness compared to 88% for 10-day concomitant therapy and 90% for 14-day concomitant therapy (P<0.001).
Compliance was slightly higher with single-capsule (98%) than concomitant therapy (97% for both durations).
Adverse effects occurred in 25% of patients on single-capsule or 10-day concomitant therapy, but in 33% on 14-day concomitant therapy (P<0.0001); serious adverse effects were rare (0.1%) in both groups.
Compliance, presence of ulcer, and central geographical region were associated with greater eradication success, while high-dose versus standard-dose PPI showed no demonstrated benefit.
This analysis of the Spanish cohort of the European H. pylori Registry (2013-2023) used propensity score matching and multivariate analysis to compare first-line treatments.

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Abstract

Introduction

The V Spanish Consensus Conference on H. pylori recommends as first-line treatment either a non-bismuth quadruple concomitant regimen (PPI, clarithromycin, amoxicillin, and metronidazole) for 14 days or a bismuth-containing quadruple therapy (PPI, bismuth, tetracycline, and metronidazole in a single-capsule) for 10 days. The superiority of one treatment over the other is currently not established.

Aims & Methods

To compare the effectiveness and safety of first-line empirical concomitant treatment versus bismuth quadruple therapy as single-capsule in Spain.
All treatment-naïve patients registered in AEG-REDCap in the Spanish cohort of the European H. pylori Registry (Hp-EuReg) from 2013 to 2023, treated with either concomitant therapy or the single-capsule, were evaluated. First, a set of pre-selected variables evaluated variations in prescriptions, observing significant differences in following: year of visit, geographical region, and patient age. Therefore, a propensity score analysis (SMR) was conducted and included in the multivariate logistic regression model to determine the modified intention-to-treat effectiveness (mITT) of both treatments. Additionally, a multivariate analysis with 10,000 bootstrap replicas was performed, balancing for geographical region and including associated variables.

Results

A total of 11,720 treatments were analysed: 6,293 (54%) with concomitant therapy (for 10 and 14 days) and 5,427 (46%) consisting of single-capsule (10 days). Concomitant therapy, both for 10 and 14 days, was associated with lower mITT effectiveness (88%; OR=0.53; [95% CI 0.43-0.66]; and 90%; OR=0.62; [0.53-0.73], respectively) compared to single-capsule therapy (93% mITT, P<0.001). Compliance (OR=6.81; [5.05-9.15]), presence of ulcer (OR=1.49; [1.17-1.91]), and central geographical region (OR=2.51 [1.94-3.29]) were the variables associated with greater eradication success (P<0.001). However, there was no demonstrated benefit of using high-dose (equivalent to 80 mg omeprazole twice daily) PPI compared to standard dose (equivalent to 40 mg omeprazole twice daily). Compliance was higher with single-capsule (98%) compared to 10- and 14-days concomitant therapy (both 97%). The incidence of adverse effects was lower with concomitant therapy for 10 days (25%) than for 14 days (33%); and the latter was significantly higher than with single-capsule (25%) (P<0.0001). Regarding serious adverse effects, 9 (0.1%) and 7 (0.1%) cases were reported with concomitant therapy and single-capsule therapy, respectively.

Conclusion

In Spain, bismuth-containing quadruple therapy prescribed as single-capsule is more effective and better tolerated than non-bismuth quadruple concomitant treatment.

Disclosure

Javier P. Gisbert has served as speaker, consultant, and advisory member for or has received research funding from: Mayoly, Allergan/Abbvie, Diasorin, Richen, Juvisé and Biocodex.
Olga P. Nyssen received research funding from: Mayoly, Allergan/Abbvie, Richen, Juvisé and Biocodex.

Conference

UEG Week Vienna 2024

Topics

Stomach & H. Pylori

Submission format

Abstract

Session

H.pylori treatment: Part 1 (Posters)

Citation

United European Gastroenterology Journal 2024; 12 (Supplement 8)

Published

2024

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Motility mayhem: The paediatric battle with gut disorders

Marc Benninga 1

Affiliations

1 Academisch Medisch Centrum Onderzoekschool Oncologie Pediatrics and Pediat. Surgery - Dep. Of Pediat, AZ Amsterdam, Netherlands

Summary

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Abstract

Event

UEG Week Berlin 2025

Topics

Neurogastroenterology & Motility Paediatrics Standards & Guidelines Stomach & H. Pylori

Session

From guidelines to clinical practice: The gut-brain connection - PPIs and guideline application in clinical practice

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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Constipation: Paediatric and adult gastroenterologist

Marc Benninga 1, Maura Corsetti 2

Affiliations

1 Academisch Medisch Centrum Onderzoekschool Oncologie Pediatrics and Pediat. Surgery - Dep. Of Pediat, AZ Amsterdam, Netherlands

2 University of Nottingham, Nottingham, United Kingdom

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Abstract

Event

UEG Week Berlin 2025

Session

When adult gastroenterologist meets paediatrician: Focus on reflux, constipation and chronic pain

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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LONG-TERM OUTCOMES AND OPTIMAL TREATMENT STRATEGIES AFTER ENDOSCOPIC SUBMUCOSAL DISSECTION FOR T1 COLORECTAL CANCER: A REAL-WORLD MULTICENTER PROSPECTIVE STUDY BY THE HIROSHIMA GI ENDOSCOPY RESEARCH GROUP

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LONG-TERM OUTCOMES AND OPTIMAL TREATMENT STRATEGIES AFTER ENDOSCOPIC SUBMUCOSAL DISSECTION FOR T1 COLORECTAL CANCER: A REAL-WORLD MULTICENTER PROSPECTIVE STUDY BY THE HIROSHIMA GI ENDOSCOPY RESEARCH GROUP

Toshio Kuwai 1, Takuro Hamada 1, Yuki Kamigaichi 1, Koki Nakamura 2, Tomohiro Miwata 3, Seiji Onogawa 4, Hideharu Okanobu 5, Akira Furudoi 6, Shinji Nagata 7, Shigeto Yoshida 8, Masaki Kunihiro 9, Yuko Hiraga 10, Shiro Okamoto 11, Shiro Oka 1

Affiliations

1 Hiroshima University Hospital, Hiroshima, Japan

2 Miyoshi Central Hospital, Miyoshi, Japan

3 Chugoku Rosai Hospital, Kure, Japan

4 Onomichi General Hospital, Onomichi, Japan

5 Hiroshima Red Cross Hospital and Atomic-Bomb Survivors Hospital, Hiroshima, Japan

6 JA Hiroshima General Hospital, Hatsukaichi, Japan

7 Hiroshima City Asa Citizens Hospital, Hiroshima, Japan

8 NHO Kure Medical Center, Kure, Japan

9 Hiroshima City Hiroshima Citizens Hospital, Hiroshima, Japan

10 Hiroshima Prefectural Hospital, Hiroshima, Japan

11 Kure Kyosai Hospital, Kure, Japan

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Abstract

Introduction

Prospective evidence of the long-term efficacy of endoscopic submucosal dissection (ESD) for T1 colorectal cancer (CRC) is insufficient.

Aims & Methods

We aimed to evaluate long-term ESD outcomes for T1 CRC, focusing on the risk stratification criteria and necessity of additional surgery.
This large-scale, multicenter, prospective cohort study was conducted by Hiroshima GI Endoscopy Research Group. All consecutive patients who underwent colorectal ESD between January 2014 and December 2018 were included, and those with pathologically confirmed T1 CRC were analyzed. Patients were classified into low-risk and high-risk groups based on histopathological risk factors for lymph node metastasis in JSCCR guidelines. High-risk patients were categorized into those who underwent additional surgery (surgery group) and those who were followed up without surgery (follow-up group).

Results

Among 2357 patients who underwent ESD for 2478 early colorectal neoplasms, 431 were diagnosed with T1 CRC. Ten recurrences (2.6%) and five T1 CRC-associated deaths (1.3%) occurred in the high-risk group, with none in the low-risk group. Five-year cumulative overall and local recurrence rates were significantly higher in the follow-up versus surgery group (7.7% and 1.9%; P=0.019 versus 6.4% and 0%; P<0.001), with no local recurrence in the surgery group. Five-year overall survival was significantly worse in the follow-up group (79.5% and 95.2%; P<0.001), while no significant difference was found in 5-y disease-specific survival (98.5% and 98.5%; P=0.447).

Characteristics	Total (n=383)	Low-risk (n=102)	High-risk (n=281)	P value	High-risk (n=281)		P value
Characteristics	Total (n=383)	Low-risk (n=102)	High-risk (n=281)	P value	Follow-up (n=74)	Surgery (n=207)	P value
Followed-up period, mean± SD, months	65.6±15.3	64.3±14.6	66.1±15.5	0.328	63.8±21.8	66.9±12.5	0.139
Mortality, n (%)	46 (12.0)	11 (10.8)	35 (12.5)	0.657	21 (28.4)	14 (6.8)	<0.001
Mortality associated with T1 CRC, n (%)	5 (1.3)	0 (0)	5 (1.8)	0.175	2 (2.7)	3 (1.5)	0.484
Recurrence, n (%)	10 (2.6)	0 (0)	10 (3.6)	0.012	6 (8.1)	4 (1.9)	0.014
Local recurrence	5 (1.3)	0 (0)	5 (1.8)	0.175	5 (6.8)	0 (0)	<0.001
Distant recurrence	6 (1.6)	0 (0)	6 (2.1)	0.137	2 (2.7)	4 (1.9)	0.694
5-year OS, %	91.1	91.2	91.1	0.854	79.7	95.2	<0.001
5-year DSS, %	98.9	100	98.5	0.177	98.4	98.5	0.42

Conclusion

No recurrence or mortality occurred in the low-risk group, suggesting that intensive surveillance may be unnecessary for these patients after curative ESD. Additional surgery could prevent local recurrence for high-risk T1 CRC, supporting a risk-based treatment approach.

Event

UEG Week Berlin 2025

Topics

Colorectal Digestive Oncology Endoscopy

Submission format

Abstract

Session

It's all about the right technique: Colorectal lesions

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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Share via Email Share on Facebook Share on X Share on LinkedIn Share on Bluesky

This content is part of Gutflix. Log in with your myUEG account, or create one free, to watch it.

Not sure what you can access? Learn more about account types.

Episode 1: UEG Journal May spotlight

Mohsan Subhani, Maria Manuela Estevinho

Summary

AI Generated

Summary is not available for this content yet.

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Was this helpful?

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Abstract

Published

2025

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Episode 5: UEG Journal September Spotlight

Djuna L. Cahen

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Shiro Oka

Episode 1: UEG Journal May spotlight

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Should we give probiotics a chance? For what?

Vanessa Stadlbauer-Köllner 1

Affiliations

1 Center for Biomarker Research in Medicine (CBmed), Graz, Austria

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Abstract

Event

UEG Week Berlin 2025

Topics

Gut Microbiota Primary Care

Session

The art of making clinical research precise: Can we unlock the microbiome?

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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