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H. PYLORI FIRST-LINE EMPIRICAL THERAPY EFFECTIVENESS AND ITS RELATIONSHIP TO ANTIBIOTIC CONSUMPTION IN THE COMMUNITY: DATA FROM THE EUROPEAN REGISTRY ON H. PYLORI MANAGEMENT (HP-EUREG)

Olga P. Nyssen 1, Guillermo José Ortega 2, Laimas Jonaitis 3, Ángeles Pérez-Aísa 4, Bojan Tepes 5, Umud Mahmudov 6, Irina Voynovan 7, Samuel J Martínez-Domínguez 8, Luis Bujanda Fernández de Piérola 9, Alfredo J. Lucendo 10, Luis Ricardo Rodrigo Sáez 11, Liudmila Vologzhanina 12, Emin Mammadov 13, Frode Lerang 14, Renate Bumane 15, Maja Denkovski 16, Galyna Fadieienko 17, Tatiana Ilchishina 18, Javier Tejedor-Tejada 19, Ana Garre 1, Gülüstan Babayeva 13, Aiman Sarsenbaeva 20, Jose Maria Huguet 21, Oleg Zaytsev 22, Farid Guliyev 23, Manuel Pabon-Carrasco 24, Monica Perona 25, Sergei Alekseenko 26, Manuel Castro-Fernández 24, Oscar Núñez Martínez 27, Igor Bakulin 28, Miguel Areia 29, Pavel Bogomolov 30, Jesús Barrio 31, Nataša Brglez Jurečič 16, Antonio Moreno 32, Blas José Gómez-Rodríguez 33, Juozas Kupcinskas 3, Antonio Gasbarrini 34, Luis Hernández Villalba 35, Dmitry S. Bordin 36, Marcis Leja 15, Oleksiy Gridnyev 17, Ricardo Pinto 37, Anna Cano Català 38, Pablo Parra 1, Leticia Moreira Ruiz 39, Francis Mégraud 40, Colm O'Morain 41, 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 Análisis de Datos, Hospital Universitario de la Princesa, CONICET, Universidad Nacional de Quilmes – Argentina, Madrid, Spain

3 Department of Gastroenterology, Lithuanian University of Health Sciences, Kaunas, Lithuania

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

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

6 Modern Hospital, Baku, Azerbaijan

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

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

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

12 Gastrocentr, Perm, Russian Federation

13 Department of Internal Medicine and Gastroenterology, Azerbaijan State Advanced Training Institute for Doctors named by A. Aliyev, Baku, Azerbaijan

14 Østfold Hospital Trust, Grålum, Norway

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

16 Interni oddelek, Diagnostic Centre, Bled, Slovenia

17 Departments the Division for the Study of the Digestive diseases and its Comorbidity with Noncommunicable Diseases, Government Institution L.T. Malaya Therapy National Institute of NAMS of Ukraine, Kharkiv, Ukraine

18 Department of Gastroenterology, SM-clinic, Saint-Petersburg, Russian Federation

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

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

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

22 First Clinical Medical Centre, Kovrov, Russian Federation

23 National Oncology Centre, Baku, Azerbaijan

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

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

26 Far Eastern State Medical University, Khabarovsk, Russian Federation

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

28 I. I. Mechnikov North-Western State Medical University, Saint-Petersburg, Russian Federation

29 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

30 Universal Clinic Private Medical Center, Moscow, Russian Federation

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

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

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

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

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

36 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

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 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

39 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

40 INSERM U1312, Université de Bordeaux, Bordeaux, France

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

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Abstract

Introduction

The link between the misuse in global antibiotic consumption and increased antimicrobial resistance is well documented. Clarithromycin-based anti-H. pylori eradication therapy as a triple regimen (encompassing a PPI plus two antibiotics) has been used empirically worldwide without antimicrobial susceptibility testing. In the last decade, a marked decreased in the effectiveness of clarithromycin-based regimens has been observed globally.

Aims & Methods

This study aimed at exploring the potential relationship between the consumption of macrolides in the overall population as a factor influencing the effectiveness of H. pylori clarithromycin-containing regimens.
Data from the European Registry on Helicobacter pylori management (Hp-EuReg) were used for this analysis. A multivariate logistic regression was built using the modified intention-to-treat (mITT) effectiveness analysis as the outcome and the following main effects: first-line treatment scheme (using the 10 most frequent antibiotic combinations), duration of treatment (as 7, 10 or 14-day lengths), proton-pump inhibitor (PPI) dose (categorised as low, standard, or high; that is, 20 mg, 40 mg or 80 mg omeprazole equivalent twice a day), compliance (that is, >90% of drug intake), and clarithromycin consumption expressed as daily doses per 1,000 inhabitants per day. Data of macrolide community consumption was taken from the European Surveillance of Antimicrobial Consumption Network (ESAC-Net). Hierarchical nested models were constructed by adding macrolide consumption, matching by year and country with the corresponding patients’ therapy, and the interaction between consumption and treatment scheme (taken from the Hp-EuReg).

Results

In total, 28,590 first-line treated patients from 24 European countries participating in the Hp-EuReg, on which data of macrolides consumption in the period 2013-2022 was available, were evaluated. Three nested models were analysed: the first one with the main effects without including macrolides consumption (A), the second with the full set of main effects (including macrolides consumption) (B) (likelihood ratio test A-B p-value=2.11.10^-2), and the third one included both macrolides consumption and interactions between this main effect and treatments (C) (likelihood ratio test B-C p-value=4.08 10^-10). Model B (without interactions) showed a global decrease in treatment mITT effectiveness (OR: 0.95 [0.91-0.99]). Model C (with interactions) showed a significant decrease in the mITT effectiveness in three different treatments (Table): triple-clarithromycin-metronidazole (OR: 0.37 [0.25-0.53]), triple-clarithromycin-amoxicillin (OR: 0.60 [0.43-0.82]), and sequential-clarithromycin-amoxicillin-metronidazole/tinidazole (OR: 0.60 [0.43-0.84]); whereas, bismuth quadruple therapy (single capsule) remained unaffected.

Table. Multivariate logistic regression (model C) evaluating the interaction between clarithromycin consumption and first-line empirical treatment effectiveness (by modified intention-to-treat) in Europe between 2013 and 2022.
OR: odds ratio; CI: confidence interval; low dose PPI – 4.5 to 27 mg omeprazole equivalents. b.i.d.; standard dose PPI – 32 to 40 mg omeprazole equivalents. b.i.d.; high dose PPI – 54 to 128 mg omeprazole equivalents. b.i.d.; A: amoxicillin; B: bismuth; C: clarithromycin; L: levofloxacin; M: metronidazole: tetracycline.; *Three-in-one single-capsule containing metronidazole. tetracycline and bismuth; C cons: clarithromycin consumption.
	OR	95% CI	p-value
Intercept	0.42	0.15-1.22	0.17
Compliance (>90% of drug intake)	7.41	6.30-8.71	1.01e-92
10 days prescriptions 14 days prescriptions	0.92 1.06	0.92-1.04 0.94-1.21	0.25 0.43
Standard-dose PPI * High-dose PPI*	1.58 1.79	1.44-1.74 1.65-1.95	1.08e-15 7.23e-31
Triple- PPI+C+A Triple- PPI+C+M Triple- PPI+A+M Triple- PPI+A+L Conco- PPI+C+A+T/M Seq- PPI+C+A+T/M Quadruple- PPI+C+A+B Quadruple- PPI+single capsule Other**	2.32 3.95 1.90 1.29 1.97 4.71 0.99 2.32 1.45	0.80-6.34 1.25-11.93 0.64-5.43 0.36-4.40 0.68-5.42 1.55-13.66 0.21-4.88 0.76-6.69 0.47-4.22	0.18 0.04 0.32 0.74 0.28 0.02 0.99 0.20 0.58
C cons Triple- PPI+C+A: C cons Triple- PPI+C+M: C cons Triple- PPI+A+M: C cons Triple- PPI+A+L: C cons Conco- PPI+C+A+T/M: C cons Seq- PPI+C+A+T/M: C cons Quadruple- PPI+C+A+B:C cons Quadruple-PPI+Single capsule: C cons Other: C cons**	1.42 0.60 0.37 0.71 0.76 0.76 0.60 0.89 0.86 0.72	1.04-1.96 0.43-0.82 0.25-0.53 0.49-1.01 0.51-1.12 0.54-1.04 0.43-0.84 0.52-1.48 0.60-1.20 0.51-1.00	0.07 0.01 1.58e-05 0.11 0.24 0.15 0.01 0.72 0.46 0.10

Conclusion

The models showed an inverse association between the clarithromycin consumption and empirical first-line therapy overall effectiveness in Europe; particularly, in those clarithromycin-containing regimens. Further research will consider a broader time lag to assess this association.

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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Endpoint, n/N (%) [95% CI]^a	AO^b	NRI^c
Achievement of CDAI clinical remission^d and endoscopic response^e Week 52 Week 148 Achievement of SF/APS clinical remission^f and endoscopic response^e Week 52 Week 148 Normalisation of hs-CRP^g or FCP^h and CDAI clinical remission^d Week 52 Week 76 Week 100 Week 124 Week 148 Normalisation of hs-CRP^g or FCP^h and SF/APS clinical remission^f Week 52 Week 76 Week 100 Week 124 Week 148 Normalisation of hs-CRP^g or FCP^h and endoscopic response^e Week 52 Week 148	100/218 (45.9) [39.3, 52.5] 71/144 (49.3) [41.1, 57.5] 98/217 (45.2) [38.5, 51.8] 65/143 (45.5) [37.3, 53.6] 112/182 (61.5) [54.5, 68.6] 86/127 (67.7) [59.6, 75.8] 89/122 (73.0) [65.1, 80.8] 85/112 (75.9) [68.0, 83.8] 86/106 (81.1) [73.7, 88.6] 101/181 (55.8) [48.6, 63.0] 78/127 (61.4) [53.0, 69.9] 79/123 (64.2) [55.8, 72.7] 74/113 (65.5) [56.7, 74.3] 75/106 (70.8) [62.1, 79.4] 94/183 (51.4) [44.1, 58.6] 80/133 (60.2) [51.8, 68.5]	100/224 (44.6) [38.1, 51.2] 105/224 (46.8) [40.0, 53.7] 98/224 (43.8) [37.3, 50.2] 91/224 (40.5) [33.6, 47.5] 112/184 (60.9) [53.8, 67.9] 115/184 (62.5) [55.1, 69.9] 115/184 (62.4) [54.9, 70.0] 112/184 (60.7) [52.8, 68.5] 113/184 (61.3) [53.9, 68.7] 101/184 (54.9) [47.7, 62.1] 100/184 (54.4) [46.5, 62.2] 97/184 (52.6) [45.0, 60.1] 93/184 (50.4) [42.8, 58.0] 95/184 (51.4) [43.6, 59.1] 94/184 (51.1) [43.9, 58.3] 90/184 (48.7) [41.1, 56.3]
Table. Achievement of improvements in combinations of clinical, endoscopic, and inflammatory biomarker endpoints Abbreviations: AE, adverse event; AO, as observed; CD, Crohn’s disease; CDAI, Crohn’s Disease Activity Index; FCP, fecal calprotectin; hs-CRP; high-sensitivity C-reactive protein; mNRI, modified nonresponder imputation; RZB, Risankizumab; SF/APS, stool frequency/abdominal pain score. The study population includes all intent-to-treat patients who received at least one dose of study drug in the SEQUENCE OLE. ^aConstruction of CIs for response rate is based on the normal approximation to the binomial distribution. ^bMissing data were addressed using multiple imputations for missed assessments, including missing value following premature study treatment discontinuation for reasons other than "lack of efficacy" or "AE limited only to CD". Visits after discontinuation from treatment caused by "lack of efficacy" or "AE limited only to CD", as well as visits on or after the initiation of RZB rescue therapy, were categorised as nonresponders. ^cCDAI clinical remission: CDAI < 150. ^dEndoscopic response: Decrease in SES-CD > 50% from baseline (or for patients with isolated ileal disease and a baseline SES-CD of 4, ≥ 2 point reduction from baseline), as scored by central reviewer. ^eSF/APS clinical remission: Average daily SF ≤ 2.8 and not worse than baseline value and average daily APS ≤ 1 and not worse than baseline value. ^fC-reactive protein (hs-CRP) ≤ 5 mg/L. ^gFCP ≤ 250 mg/kg.

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