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EXPERIENCE WITH SINGLE-CAPSULE BISMUTH QUADRUPLE THERAPY IN 11,000 PATIENTS FROM THE EUROPEAN REGISTRY ON HELICOBACTER PYLORI MANAGEMENT (HP-EUREG)

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EXPERIENCE WITH SINGLE-CAPSULE BISMUTH QUADRUPLE THERAPY IN 11,000 PATIENTS FROM THE EUROPEAN REGISTRY ON HELICOBACTER PYLORI MANAGEMENT (HP-EUREG)

Olga P. Nyssen 1, Ángeles Pérez-Aísa 2, Luis Ricardo Rodrigo Sáez 3, Samuel J Martínez-Domínguez 4, Alfredo J. Lucendo 5, Javier Tejedor-Tejada 6, Blas José Gómez-Rodríguez 7, Oscar Núñez Martínez 8, Monica Perona 9, Antonio Moreno 10, Jose Maria Huguet 11, Manuel Pabon-Carrasco 12, Marco Romano 13, Manuel Castro-Fernández 12, Matteo Pavoni 14, Antonio Gasbarrini 15, Inmaculada Ortiz Polo 16, Fernando Bermejo 17, Montserrat Planella de Rubinat 18, Jesús Barrio 19, Miguel Areia 20, Giuseppe Losurdo 21, Enrique Alfaro 4, M. Soledad Marcos 22, Georges Kamtoh 23, Eduardo Iyo 24, Ramón Pajares Villarroya 25, B. Velayos 26, Ana Pozo 27, Rosa Rosania 28, Miguel Fernandez-Bermejo 29, Antonietta Gerarda Gravina 13, Noelia Alcaide 26, Alma Keco-Huerga 12, Consuelo Ramirez 18, Luis Fernández-Salazar 26, Antonio Cuadrado 30, Vladimir Milivojevic 31, Debora Compare 32, Luis Hernández Villalba 33, Ricardo Pinto 34, Wojciech Marlicz 35, Marino Venerito 28, Michael Doulberis 36, 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 Department of Gastroenterology, Hospital Universitario Costa del Sol, Redes de Investigación Cooperativa Orientada a Resultados en Salud (RICORS), Marbella, Spain

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

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

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

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

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

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

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

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

13 Department of Gastroenterology and Endoscopy, Department of Precision Medicine, Università Vanvitelli, Napoli, Italy

14 Department of Medical and Surgical Sciences, Sant'Orsola-Malpighi University Hospital, Bologna, Italy

15 Department of Internal Medicine and Gastroenterology, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy

16 Department of Gastroenterology, Hospital Universitario y Politécnico la Fe, Valencia, Spain

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

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

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

20 Department of Gastroenterology, Portuguese Oncology Institute of Coimbra, Faculty of Medicine of the University of Porto (FMUP), Center for Health Technology and Services Research (CINTESIS), Coimbra, Portugal

21 Department of Gastroenterology, Department of Precision and Regenerative Medicine and Ionian Area, University of Bari, Bari, Italy

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

23 Hepatic Medical, Private Medical Center, Krakow, Poland

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

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

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

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

28 Department of Gastroenterology, Hepatology and Infectious Diseases, Otto von Guericke University Hospital, Magdeburg, Germany

29 Hospital Parque San Francisco, Cáceres, 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 Clinical Center of Serbia and School of Medicine, University of Belgrade, Belgrade, Serbia

32 Department of Gastroenterology, "Federico II" University, Napoli, Italy

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

34 Gastroenterology Department, Centro Hospitalar do Porto, Universidade do Porto, Instituto De Ciências Biomédicas de Abel Salazar, Center for Research in Health Technologies and Information Systems (CINTESIS), Porto, Portugal

35 Department of Gastroenterology, Pomeranian Medical University in Szczecin, The Centre for Digestive Diseases, Endoklinika, Szczecin, Poland

36 Department of Gastroenterology, Kantonsspital Aarau, Aarau, Switzerland

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

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Abstract

Introduction

There has been a resurgence in the use of bismuth quadruple therapy (PPI, bismuth, tetracycline and metronidazole) in Europe with the commercialisation of a three-in-one single-capsule formulation, but the experience with this regimen is still limited.

Aims & Methods

To evaluate the effectiveness and safety of the three-in-one single-capsule in the European Registry on Helicobacter pylori Management (Hp-EuReg).
International, multicenter, prospective, non-interventional registry aimed to evaluate the decisions and outcomes of H. pylori management by European gastroenterologists (Hp-EuReg). All infected adult patients treated with 10-day single-capsule according to data sheet (3 capsules/6h) or alternative three times a day (4 capsules/8h) prescriptions were systematically registered at AEG-REDCap e-CRF until December 2023. Variables included: Patient’s demographics, previous eradication attempts, prescribed treatment, adverse events, and outcomes. Modified intention-to-treat (mITT) and per-protocol (PP) analyses were performed, and data were subject to quality review.

Results

Of the 70,683 patients included in the Hp-EuReg, 11,130 (16%) received single-capsule bismuth quadruple therapy. The majority of these patients were naïve (77%), with an average age of 51 years, 61% female and 14% with peptic ulcer. Overall, the single-capsule achieved a high eradication rate based on the mITT (92%) and PP (93%) analyses. Effectiveness (mITT) was higher when using the single-capsule as a first-line treatment (94%), but it had also high effectiveness as a rescue therapy, both in second-line (88%) or subsequent lines of therapy (3^rd-6^th lines: 84%) (Table 1). Compliance with treatment (>90% of drug intake) was reported in 97% of cases and was the factor most closely associated with the effectiveness of treatment. Adverse events (26%) were generally mild and transient; only 0.1% of patients reported serious adverse events, leading to the discontinuation of treatment in 1.7% of patients.

Table 1. Three-in-one single-capsule effectiveness in first-line and consecutive rescue treatment lines.
Of the total of treatments included in the Hp-EuReg up to December 2023 (i.e., N= 70,683); *achieved over 90% effectiveness when therapy was optimised (i.e., using standard-dose PPIs, that is 40 mg omeprazole equivalent twice a day); mITT: modified intention-to-treat; PP: per-protocol, N: total number of patients analysed, 95% CI –confidence interval.
	Use, N (%)	mITT, N (%)	95% CI	PP, N (%)	95% CI
Overall	11,130 (16*)	10,441 (92)	(91-93)	10,248 (93)	(92-93)
1^st line (naïve)	8,551 (77)	8,041 (94)	(93-94)	7,909 (94)	(94-95)
2^nd line	1,783 (16)	1,659 (88)**	(86-89)	1,621 (89)	(87-90)
3^rd to 6^thline	796 (7.2)	741 (84)	(81-87)	718 (85)	(83-88)

Conclusion

The 10-day treatment with single-capsule bismuth quadruple therapy achieves H. pylori eradication in approximately 90% of patients by mITT in real-world clinical practice, both as a first-line and rescue treatment, with a favourable safety profile.

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.

Event

UEG Week Vienna 2024

Topics

Neurogastroenterology & Motility Stomach & H. Pylori

Submission format

Abstract

Session

Dyspepsia and H.pylori

Citation

United European Gastroenterology Journal 2024; 12 (Supplement 8)

Published

2024

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Table 1. Three-in-one single-capsule effectiveness in first-line and consecutive rescue treatment lines.
	Use, N (%)	mITT, N (%)	95% CI	PP, N (%)	95% CI
Overall	8,302 (14*)	7,729 (91)	(91-92)	7573 (92)	(92-93)
1^st line (naïve)	6,227 (75)	5,797 (93)	(92-94)	5,696 (94)	(93-94)
2^nd line	1,441(17)	1,344 (87)	(85-89)	1,311 (88)	(86-90)
3^rd line	504 (6.1)	472 (88)	(85-91)	456 (89)	(86-92)
Rescue (3^rd to 6^thline)	633 (7.6)	588 (86)	(83-89)	566 (88)	(85-90)
*Of the total of treatments included in the Hp-EuReg up to January 2023 (i.e., N= 59,689); mITT: modified intention-to-treat; PP: per-protocol, N: total number of patients analysed.

Comorbidities Diverticular disease	Importance(%) 16.68
Hypertension	5.69
Hernia	4.64
Haemorrhoids	4.42
Osteoarthritis	3.29
Asthma	2.82
Gastro-oesophageal reflux disease without oesophagitis	2.74
Personal history of psychoactive substance abuse	2.51
Pure hypercholesterolaemia	2.38
Cholelithiasis	2.20

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