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EMPIRICAL SECOND-LINE TREATMENTS IN EUROPE: DATA FROM 9,000 CASES FROM THE EUROPEAN REGISTRY ON HELICOBACTER PYLORI MANAGEMENT (HP-EUREG)

Olga P. Nyssen 1, Laimas Jonaitis 2, Ángeles Pérez-Aísa 3, Luis Ricardo Rodrigo Sáez 4, Samuel J Martínez-Domínguez 5, Bojan Tepes 6, Liudmila Vologzhanina 7, Ana Garre 1, Luis Bujanda Fernández de Piérola 8, Manuel Pabon-Carrasco 9, Manuel Castro-Fernández 9, Frode Lerang 10, Irina Voynovan 11, Alfredo J. Lucendo 12, Jose Maria Huguet 13, Javier Tejedor-Tejada 14, Renate Bumane 15, Jesús Barrio 16, Pavel Bogomolov 17, Matteo Pavoni 18, Vladimir Milivojevic 19, B. Velayos 20, Maja Denkovski 21, Blas José Gómez-Rodríguez 22, Thomas Butler 23, Fernando Bermejo 24, Giuseppe Losurdo 25, Miguel Areia 26, Aiman Sarsenbaeva 27, Alma Keco-Huerga 9, Oscar Núñez Martínez 28, Antonio Gasbarrini 29, Rustam A Abdulkhakov 30, Doron Boltin 31, Georges Kamtoh 32, Ian Beales 33, Juozas Kupcinskas 2, Luis Hernández Villalba 34, Dmitry S. Bordin 35, Marcis Leja 15, Sinead Smith 36, Ricardo Pinto 37, Wojciech Marlicz 38, Perminder S. Phull 39, Anna Cano Català 40, Pablo Parra 1, Leticia Moreira Ruiz 41, Francis Mégraud 42, Colm O'Morain 36, 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, Lithuanian University of Health Sciences, Kaunas, Lithuania

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, Universidad de Oviedo, Oviedo, Spain

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

6 Department of Gastroenterology, DC Rogaska, Rogaska Slatina, Slovenia

7 Gastrocentr, Perm, Russian Federation

8 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

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

10 Østfold Hospital Trust, Grålum, Norway

11 A.S. Loginov Moscow Clinical Scientific Center, Moscow, Russian Federation

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

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

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

15 Department of Gastroenterology, Digestive Diseases Centre, Institute of Clinical and Preventive Medicine, University of Latvia, Riga, Latvia

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

17 Universal Clinic Private Medical Center, Moscow, Russian Federation

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

19 Clinical Center of Serbia and School of Medicine, University of Belgrade, Belgrade, Serbia

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

21 Interni oddelek, Diagnostic Centre, Bled, Slovenia

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

23 Clinical Medicine, Trinity College Dublin, Department of Gastroenterology, Tallaght University Hospital, Dublin, Ireland

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

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

26 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

27 Department of Gastroenterology, Chelyabinsk Regional Clinical Hospital, Chelyabinsk, Russian Federation

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

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

30 Department of Hospital Medicine, Kazan State Medical University, Kazan, Russian Federation

31 Department of Gastroenterology, Rabin Medical Center, Tel Aviv University, Tel Aviv, Israel

32 Hepatic Medical, Private Medical Center, Krakow, Poland

33 Norwich Medical School, University of East Anglia, Norwich, United Kingdom

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

35 Department of Pancreatic, Biliary and upper digestive tract disorders, A. S. Loginov Moscow clinical scientific center, Department of outpatient therapy and family medicine, Tver State Medical University, Moscow, Russian Federation

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

37 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

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

39 Department of Digestive Disorders, Aberdeen Royal Infirmary, Aberdeen, United Kingdom

40 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

41 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

42 INSERM U1312, Université de Bordeaux, Bordeaux, France

Summary

AI Generated

A prospective European registry of 8,984 patients evaluated second-line empirical H. pylori eradication therapy effectiveness, finding 83% overall cure rates but identifying specific optimized regimens achieving over 90% effectiveness.

Overall second-line empirical therapy achieved 83% eradication rates by both modified intention-to-treat and per-protocol analyses, with 96.5% patient compliance and 23% reporting mostly mild adverse events.
Optimized regimens (14-day duration with high-dose PPIs) including levofloxacin triple therapy, bismuth quadruple therapies with metronidazole-tetracycline or clarithromycin-amoxicillin, and clarithromycin-amoxicillin-metronidazole quadruple therapy showed optimal effectiveness.
Bismuth quadruple therapy as single-capsule achieved over 90% cure rates with standard-dose PPIs for 10 days, while moxifloxacin triple therapy achieved 92% effectiveness after first-line clarithromycin failure.
None of the European regions achieved optimal effectiveness overall, with regional cure rates ranging from 72% in Northern Europe to 84-85% in other regions.
This registry included patients from 38 European countries with dyspepsia (70%) and gastroduodenal ulcer (15%) as the most common treatment indications.

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Abstract

Introduction

After a first eradication attempt, approximately 10-20% of patients will fail to achieve H. pylori eradication.

Aims & Methods

To evaluate the effectiveness of second-line empirical treatment.
A systematic, prospective, registry of the clinical practice of European gastroenterologists (38 countries) on H. pylori management was established. All infected adult patients were systematically registered at AEG-REDCap e-CRF until December 2023. Modified intention-to-treat (mITT) and per-protocol (PP) analyses were performed.

Results

Overall, 8,984 patients received a second-line empirical therapy. Mean age was of 50 years, 66% were women, and 5% had penicillin allergy. Most frequent treatment indications were dyspepsia (70%) and gastroduodenal ulcer (15%). Overall effectiveness was 83% (both by mITT and PP). Over 96.5% of patients were compliant. Adverse events were reported in 23% of the cases, most of them mild. Most frequent second-line prescriptions and their effectiveness by region is shown in table 1. None of the European regions achieved an optimal effectiveness. However, in those patients receiving optimised therapy (i.e., 14-days and high dose PPIs), triple regimens containing levofloxacin and bismuth quadruple therapies either with metronidazole-tetracycline or clarithromycin-amoxicillin, as well as quadruple therapy with clarithromycin-amoxicillin-metronidazole, showed optimal effectiveness. Also, 10-day bismuth quadruple therapy as single-capsule achieved over 90% cure rates when prescribed with standard PPI doses. After failure of first-line clarithromycin-containing therapy, optimal eradication was only obtained with moxifloxacin-containing triple therapy (92%). Quadruple therapy with clarithromycin-amoxicillin-metronidazole and bismuth quadruple therapies either with clarithromycin-amoxicillin, amoxicillin-levofloxacin or the single-capsule provided encouraging results (>85%).

Table 1. Second-line empirical treatment prescriptions and effectiveness by treatment scheme and geographical region.
95% CI –confidence interval; mITT: modified intention-to-treat; PP: per-protocol, N: total number of patients analysed; C – clarithromycin; M – metronidazole; A – amoxicillin; L – levofloxacin; B – bismuth salts; Tc – tetracycline; R – rifabutin; Mx – moxifloxacin; Other – Other second-line empirical treatments with less than 150 patients treated in each category; East – Ukraine, Serbia, Bulgaria, Turkey, Russia , Romania, Albania, North Macedonia; East-Centre – Croatia, Poland, Hungary, Latvia, Lithuania, Greece, Slovenia, Czech Rep, Azerbaijan, Slovakia, Malta; South-West – Portugal, Spain; West-Centre – France, Austria, Belgium, Germany, Italy; North – United Kingdom, Finland, The Netherlands, Ireland, Israel, Norway, Switzerland, Sweden, Denmark; three-in-one single-capsule containing metronidazole tetracycline and bismuth; *achieved over 90% effectiveness when optimised (high-dose PPIs and 14-days length in all schemes but the single-capsule optimised with standard-dose PPIs).
Treatment	N	Use (%)	mITT, N (%)	(95% CI)	PP, N (%)	(95% CI)
Triple-A+L Single-capsule* Quadruple-A+L+B Quadruple-C+A+M Triple-C+A Quadruple-M+Tc+B Quadruple-C+A+B Triple-A+M Triple-A+R Triple-A+Mx Other Overall Overall (optimised conditions)	2,212 1,783 1,170 560 525 451 370 225 212 153 1,013 8,674 2,005	25.5 20.6 13.5 6.5 6.1 5.2 4.3 2.6 2.4 1.8 11.5 100 23.1	1,959 (81) 1,659 (88) 929 (85) 534 (85) 424 (79) 405 (83) 251 (89) 198 (62) 189 (83) 147 (92) NA 7,563 (83) 1,747 (89)	(79-83) (86-89) (83-87) (82-88) (75-83) (79-87) (85-93) (55-69) (77-88) (87-97) NA (82-84) (87-90)	1,936 (81) 1,621 (89) 910 (85) 523 (85) 416 (79) 386 (85) 240 (90) 195 (63) 187 (83) 147 (92) NA 7,410 (83) 1,709 (89)	(79-83) (87-90) (83-88) (82-89) (75-83) (81-88) (86-94) (56-70) (77-89) (87-97) NA (83-84) (88-91)
East East-Centre South-West West-Centre North Total	1,425 1,625 4,190 1,103 631 8,974	15.9 18.1 46.7 12.3 7.0 100	1,159 (84) 1,160 (84) 3,973 (83) 979 (84) 547 (72) 7,803 (83)	(82-86) (82-86) (82-85) (82-87) (68-76) (82-84)	1,121 (84) 1,147 (84) 3,895 (84) 962 (85) 530 (73) 7,641 (83)	(82-87) (82-87) (83-85) (82-87) (69-77) (83-84)

Conclusion

In Europe, empirical second-line treatment achieves optimal effectiveness with bismuth quadruple therapy as single-capsule when prescribed standard doses of PPIs, and when regimens including triple therapy with levofloxacin, quadruple therapy with clarithromycin-amoxicillin-metronidazole and bismuth quadruple therapies with metronidazole-tetracycline or clarithromycin-amoxicillin are prescribed for 14 days and with high-dose PPIs. Many other second-line treatments evaluated achieved low eradication rates.

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 (Posters)

Citation

United European Gastroenterology Journal 2024; 12 (Supplement 8)

Published

2024

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