Nutrients and tastants in the gastric accommodation reflex

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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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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.

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 Gisbert 1

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

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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Introduction

Potassium-competitive acid blockers (P-CABs) offer prolonged acid suppression and are promising agents for Helicobacter pylori eradication. Prospective studies evaluating the efficacy of tegoprazan-based triple therapy according to dosage differences have been scarce.

Aims & Methods

This study aimed to assess the efficacy and safety of tegoprazan-based versus lansoprazole-based standard triple therapy (STT). This multicenter randomized controlled study enrolled treatment-naïve adults with H. pylori infection in 18 institutions from February 2023 to April 2024. Participants were randomized 1:1:1 to receive tegoprazan 50 mg (TAC1), tegoprazan 100 mg (TAC2), or lansoprazole 30 mg (LAC) with amoxicillin 1000 mg and clarithromycin 500 mg twice daily for 14 days. The primary endpoint was the eradication rate, analyzed in the full analysis set (FAS) and per-protocol set (PPS). Secondary endpoints included eradication rates stratified by clarithromycin resistance, as determined by 23S rRNA genotyping. Non-inferiority was established if the lower bound of the 95% confidence interval (CI) for the difference in eradication rates was greater than -10%.

Results

A total of 382 patients were randomized, of whom 364 completed the study. The FAS included 372 participants after excluding those who did not receive any study medication, lacked safety data, or violated eligibility criteria. The PPS comprised 355 participants after excluding 17 protocol violators. In the FAS analysis, eradication rates were 85.95% for TAC1, 85.48% for TAC2, and 78.74% for LAC. Both TAC1 (p = 0.0002 vs. LAC) and TAC2 (p = 0.0003 vs. LAC) demonstrated non-inferiority. In the PPS analysis, eradication rates were 88.50% for TAC1, 87.39% for TAC2, and 81.30% for LAC, with TAC1 (p < 0.0001 vs. LAC) and TAC2 (p = 0.0003 vs. LAC) maintaining non-inferiority. Among 275 clarithromycin-susceptible patients in the PPS, eradication rates were 96.74% (TAC1), 98.88% (TAC2), and 94.68% (LAC). Among 80 clarithromycin-resistant patients, eradication rates were 52.38% (TAC1), 53.33% (TAC2), and 37.93% (LAC). In both subgroups, there were no significant differences between either TAC1 or TAC2 and the LAC group. Adverse event rates were comparable across groups, and no serious adverse events were reported. No significant differences in adverse event rates were observed across groups, and no serious adverse events occurred.

	TAC1 group	TAC2 group	LAC group
FAS, n	121	124	127
Successful H. pylori eradication, n (%)	104 (85.95%)	106 (85.48%)	100 (78.74%)
Difference from LAC group (95% CI)	7.21 (-2.22, 16.64)	6.74 (-2.69, 16.18)
p-value	0.0002	0.0003
PPS, n	113	119	123
Successful H. pylori eradication, n (%)	100 (88.5%)	104 (87.39%)	100 (81.30%)
Difference from LAC group (95% CI)	7.19 (-1.87, 16.26)	6.09 (-3.02, 15.21)
p-value	<0.0001	0.0003

Conclusion

Tegoprazan-based STT demonstrated non-inferiority to lansoprazole-based STT, achieving eradication rates above 80% in the FAS population. Given its efficacy and safety profile, tegoprazan-based triple therapy may serve as an effective first-line treatment option for H. pylori eradication.

Disclosure

This study was funded in full by HK inno.N Corp., Seoul, Republic of Korea. HK inno.N Corp. contributed to the study design, data management, statistical analysis, and approval of publication in co-operation with all the authors. No other potential conflicts of interest relevant to this article were reported.

A RANDOMIZED, DOUBLE-BLIND, ACTIVE-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OF TEGOPRAZAN-BASED STANDARD TRIPLE THERAPY FOR HELICOBACTER PYLORI ERADICATION

1 Chung-Ang University College of Medicine, Seoul, Korea, Republic of

2 Soon Chun Hyang University College of Medicine, Bucheon, Korea, Republic of

3 Center for Gastric Cancer, National Cancer Center, Goyang, Korea, Republic of

4 Hallym University College of Medicine, ChunCheon, Korea, Republic of

5 Konyang University College of Medicine, Daejeon, Korea, Republic of

6 College of Medicine, Korea University, Seoul, Korea, Republic of

7 School of Medicine, Kyungpook National University, Daegu, Korea, Republic of

8 Gachon University Gil Medical Center, Incheon, Korea, Republic of

9 Yonsei University College of Medicine, Seoul, Korea, Republic of

10 University of Ulsan College of Medicine, Seoul, Korea, Republic of

11 The Catholic University of Korea, Seoul, Korea, Republic of

12 Hanyang University College of Medicine, Guri, Korea, Republic of

13 Jeonbuk National University Hospital, Jeonju, Korea, Republic of

14 Ewha Womans University College of Medicine, Seoul, Korea, Republic of

15 Inje University College of Medicine, Busan, Korea, Republic of

16 Chungnam National University School of Medicine, Daejeon, Korea, Republic of

17 Pusan National University School of Medicine and Research Institute for Convergence of Biomedical Science and Technology, Yangsan, Korea, Republic of

18 Chonnam National University Medical School, Hwasun, Korea, Republic of

Conference

UEG Week Berlin 2025

Topics

Stomach & H. Pylori

Submission format

Abstract

Session

New therapies in H. pylori (Posters)

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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