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REAL-WORLD EFFECTIVENESS OF FIRST-LINE HELICOBACTER PYLORI THERAPIES ACROSS EUROPE: A 13-YEAR MULTINATIONAL ANALYSIS OF 68,361 PATIENTS FROM THE EUROPEAN REGISTRY ON H. PYLORI MANAGEMENT (HP-EUREG)

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REAL-WORLD EFFECTIVENESS OF FIRST-LINE HELICOBACTER PYLORI THERAPIES ACROSS EUROPE: A 13-YEAR MULTINATIONAL ANALYSIS OF 68,361 PATIENTS FROM THE EUROPEAN REGISTRY ON H. PYLORI MANAGEMENT (HP-EUREG)

Samuel Jesús Martínez-Domínguez 1,2,3, Nuria Montes 4,5,6, Enrique Ceamanos Ibarra 2,1, Laimas Virginijus Jonaitis* 7, Ángeles Pérez-Aísa 8, Umud Mahmudov 9, Irina Voynovan 10, Bojan Tepes 11, Liudmila Vologzhanina 12, Alfredo J. Lucendo 13, Emin Mammadov 14, Javier Tejedor-Tejada 15, Sayar Abdulkhakov 16, Boris Starostin 17, Matteo Pavoni 18, Maja Denkovski 19, Rashad Hasanov 20, Marcis Leja 21, Galyna Fadieienko 22, Tatiana Ilchishina 23, Gülüstan Babayeva 24, Ana Garre Vázquez 4,6,25, Monica Perona 26, M. Soledad Marcos 27, Luis Bujanda 28, Jose Maria Huguet 29, Oleg Zaytsev 30, Antonietta Gerarda Gravina 31, Aiman Sarsenbaeva 32, Emin Verdiyev 33, Manuel Pabon-Carrasco 34, Oscar Núñez Martínez 35, Farid Guliyev 36, Sergei Alekseenko 37, Thomas Butler 38, Jesús Barrio 39, Juozas Kupcinskas 7, Dmitry Bordin 40, Antonio Gasbarrini 41, Oleksiy Gridnyev 42, Sinead Smith 38, Mónica Sánchez Alonso 43, Virginia Flores 44, Irene Arteagoitia 45, Manuel Jiménez-Moreno 46, Pablo Parra 4,6,25, Leticia Moreira Ruiz 47,48,49, Francis Mégraud 50, Colm O'Morain 51, Olga P. Nyssen 4,6,25, Javier P. Gisbert 6,25,4

Affiliations

1 Hospital Clínico Universitario Lozano Blesa, Zaragoza, Spain

2 Instituto de Investigación Sanitaria de Aragón (IIS Aragón), Zaragoza, Spain

3 Facultad de Medicina de la Universidad de Zaragoza, CIBERehd, Zaragoza, Spain

4 Hospital Universitario de La Princesa, Madrid, Spain

5 Faculty of Pharmacy, Universidad San Pablo-CEU, CEU-Universities, Boadilla del Monte, Spain

6 Instituto de Investigación Sanitaria Princesa (IIS-Princesa), Madrid, Spain

7 Lithuanian University of Health Sciences, Kaunas, Lithuania

8 Agencia Sanitaria Costa del Sol, Marbella, Spain

9 Modern Hospital, Baku, Azerbaijan

10 Loginov Moscow Clinical Scientific Center, Moscow, Russian Federation

11 DC ROGASKA d.o.o., Rogaska Slatina, Slovenia

12 Gastrocentr, Perm, Russian Federation

13 Hospital General de Tomelloso, Madrid, Spain

14 Azerbaijan State Advanced Training Institute for Doctors named by A. Aliyev, Baku, Azerbaijan

15 Hospital Universitario de Cabueñes, Cabueñes, Spain

16 Kazan Federal University, Kazan, Russian Federation

17 Saint-Petersburg State Budgetary Institution Healthcare City Policlinic 38, St.-Petersburg, Russian Federation

18 Sant'Orsola-Malpighi University Hospital, Bologna, Italy

19 Interni oddelek, Diagnostic Centre, Bled, Slovenia

20 German Hospital Baku, Baku, Azerbaijan

21 University of Latvia, Riga, Latvia

22 Malaya Therapy National Institute of NAMS of Ukraine, Kharkiv, Ukraine

23 SM-clinic, Saint-Petersburg, Russian Federation

24 Azerbaijan State Advanced Training Institute for doctors named after A.ALIYEV, Baku, Azerbaijan

25 Universidad Autónoma de Madrid, CIBERehd, Madrid, Spain

26 Hospital Quirón Marbella, Marbella, Spain

27 Hospital 12 de Octubre, Madrid, Spain

28 Biodonostia Health Research Institute, San Sebastián, Spain

29 Hospital General Universitario de Valencia, Valencia, Spain

30 First Clinical Medical Centre, Kovrov, Russian Federation

31 Division of Hepatogastroenterology, University of Campania "Luigi Vanvitelli", Naples, Italy

32 Chelyabinsk Regional Clinical Hospital, Chelyabinsk, Russian Federation

33 Merkezi Klinik Xestexana, Baku, Azerbaijan

34 Hospital Universitario Virgen de Valme, Sevilla, Spain

35 Hospital Sanitas La Moraleja, San Sebastian De Los Reyes, Spain

36 National Center Of Oncology, Baku, Azerbaijan

37 Fare Estern State Medical University, Khabarovsk, Russian Federation

38 Trinity College Dublin, Dublin, Ireland

39 Hospital Universitario Río Hortega, Valladolid, Spain

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

41 Fondazione Policlinico Universitario Gemelli IRCCS, Università’ Cattolica, Rome, Italy

42 /National institute of therapy named L.T.Malaya NAMS of Ukraine, Kharkiv, Ukraine

43 Hospital de Puertollano, Puertollano, Spain

44 Hospital Gregorio Marañón, Madrid, Spain

45 Hospital Universitario de Cruces, Bilbao, Spain

46 Hospital Universitario de Burgos, Burgos, Spain

47 CIBERehd, Barcelona, Spain

48 ), Institut d’Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), University of Barcelona, Barcelonaspa, Spain

49 Hospital Clinic de Barcelona, Barcelona, Spain

50 INSERM U1312 BRIC, Université de Bordeaux, Bordeaux, France

51 Trinity College Dublin - Faculty of Health Sciences, Trinity College Dublin; Dublin/IE, Dublin, Ireland

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Abstract

Introduction

Eradication regimens for Helicobacter pylori (H. pylori) infection have evolved over time in response to changes in antibiotic resistance patterns and clinical practice. However, real-world comparative effectiveness studies remain limited by treatment selection bias and geographical heterogeneity, underscoring the need for periodic evaluation.

Aims & Methods

To assess prescription patterns, effectiveness, and safety of empirical first-line treatments in Europe. This prospective, non-interventional registry of gastroenterologists clinical practice in Europe (Hp-EuReg, WorldHpReg partner) collected data from 2013 to December 2025. The six most frequently prescribed regimens, representing >90% of first-line treatments, were selected for analysis. Differences across countries and the year of visit were adjusted using propensity score weighting based on gradient boosting models (GBM) to estimate the average treatment effect (ATE). Effectiveness was evaluated using modified intention-to-treat (mITT) analyses through multivariate logistic regression with 10,000 stratified bootstraps samples, adjusting for treatment, age, sex, proton pump inhibitor (PPI) dose, treatment duration, probiotic use, compliance, year of visit, and country. Due to class imbalance (89% success vs. 11% failure), models were additionally retrained using ROSE oversampling to improve robustness. Safety was assessed based on the occurrence of at least one adverse event.

Results

A total of 68,361 treatments from 39 countries were analysed: clarithromycin-based triple therapy with amoxicillin/metronidazole (triple-CA/M, n=23,903, 35%), bismuth-based quadruple therapy with metronidazole–tetracycline (quad-sc/BMTc: single-capsule and traditional format, n=12,716, 19%), concomitant quadruple therapy with clarithromycin–amoxicillin–tinidazole/metronidazole (conco-CAT/M, n=11,024, 16%), clarithromycin–amoxicillin–bismuth quadruple therapy (quad-CAB, n=9,061, 13%), sequential quadruple therapy with CAT/M (seq-CAT/M, n=3,643, 5%), and others (n=8,014, 11%). Quadruple regimens achieved >90% effectiveness but were associated with a higher incidence of adverse events (20–25%) compared with triple therapies (13%), which showed effectiveness <90%. The quad-sc/BMTc regimen was significantly more effective than triple-CA/M (OR=3.76; 95%CI 3.53-4.01), as well as conco-CAT/M (OR=2.02; 95%CI 1.91-2.13) and quad-CAB (OR 2.12; 95%CI 1.99-2.26). Standard/high PPI dose (OR=1.40; 95%CI 1.34-1.46 and OR=1.57; 95%CI 1.51-1.64), treatment durations of 10 or 14 days (OR=1.21; 95%CI 1.13-1.29 and OR=1.52; 95%CI 1.42-1.62), adequate compliance (OR=14.50; 95%CI 13.01-16.16), and probiotic use (OR=1.46; 95%CI 1.40-1.53) were all associated with higher eradication rates (Table 1).

Table 1. Multivariable analysis models of effectiveness, retrained using ROSE oversampling.
mITT: modified intention-to-treat. CI: confidence interval. Conco: concomitant. Quad: quadruple. Sc: single-capsule. Seq: sequential. Drugs: A, amoxicillin; B, bismuth salts; C, clarithromycin; L, levofloxacin; M, metronidazole; T, tinidazole; Tc, tetracycline. PPI: proton pump inhibitor.
Dependent: mITT		Failure (N=30,707)	Success (N=50,541)	OR (95% CI, p-value)
Treatment	Triple-CA/M Seq-CAT/M Conco-CAT/M Quad-sc/BMTc Quad-CAB	15,223 (49.6%) 1,991 (6.5%) 6,012 (19.6%) 4,579 (14.9%) 2,902 (9.5%)	17,818 (35.3%) 2,969 (5.9%) 10,077 (19.9%) 11,886 (23.5%) 7,791 (15.4%)	- 1.26 (1.15-1.38, p<0.001) 2.02 (1.91-2.13, p<0.001) 3.76 (3.53-4.01, p<0.001) 2.12 (1.99-2.26, p<0.001)
Age	Mean ± SD	50.1 ± 15.3	50.2 ± 15.2	1.00 (1.00-1.00, p<0.001)
Sex	Female Male	19,670 (64.1%) 11,037 (35.9%)	29,614 (58.6%) 20,927 (41.4%)	- 1.20 (1.16-1.23, p<0.001)
Treatment length	7 days 10 days 14 days	4,330 (14.1%) 14,209 (46.3%) 12,168 (39.6%)	3,662 (7.2%) 23,278 (46.1%) 23,601 (46.7%)	- 1.21 (1.13-1.29, p<0.001) 1.52 (1.42-1.62, p<0.001)
Dose PPI	Low Standard High	16,206 (52.8%) 7,086 (23.1%) 7,415 (24.1%)	20,987 (41.5%) 13,324 (26.4%) 16,230 (32.1%)	- 1.40 (1.34-1.46, p<0.001) 1.57 (1.51-1.64, p<0.001)
Compliance	No (< 90% drug intake) Yes (>90% drug intake)	2,527 (8.2%) 28,180 (91.8%)	425 (0.8%) 50,116 (99.2%)	- 14.50 (13.01-16.16, p<0.001)
Probiotic use	No Yes	25,657 (83.6%) 5,050 (16.4%)	37,518 (74.2%) 13,023 (25.8%)	- 1.46 (1.40-1.53, p<0.001)

Conclusion

In European clinical practice, the quad-sc/BMTc, conco-CAT/M and quad-CAB achieved >90% effectiveness, but were associated with lower tolerability. The key determinants of eradication success were adequate adherence, standard/high PPI doses, and treatment durations of 10–14 days.

Event

UEG Week Barcelona 2026

Topics

Gut Microbiota Stomach & H. Pylori Mechanisms & Personalised Medicine Digestive Oncology Oesophagus

Submission format

Abstract

Session

H. pylori: At the nexus of molecular mechanisms and clinical care

Citation

2026: United European Gastroenterology Journal 2026; 14 (S1)

Published

2026

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