TRENDS IN THE PRESCRIPTION OF EMPIRICAL TREATMENTS AND THEIR EFFECTIVENESS IN NAÏVE PATIENTS OVER 10 YEARS (2013-2022) IN EUROPE: DATA FROM THE EUROPEAN REGISTRY ON THE MANAGEMENT OF HELICOBACTER PYLORI INFECTION (HP-EUREG)

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Introduction

The infection by H. pylori can be successfully treated and eradicated if the recommendations from consensus documents are followed correctly. It is essential to continuously assess the applicability of these recommendations to confirm what happens in clinical practice.

Aims & Methods

Multicentre, prospective registry evaluating the decisions and outcomes of Helicobacter pylori management by European gastroenterologists. Data were registered at AEG-REDCap e-CRF until December 2023. Modified intention-to-treat (mITT) and time trend analyses were performed.

Results

Overall, 58,334 (82%) were first-line empirical prescriptions. The total number of different therapeutic regimens prescribed exceeded 100. Triple therapy prescriptions decreased from approximately 60% during 2013/15 to 30% in 2023; likewise, non-bismuth concomitant therapy use decreased from 21% in 2013/15 to 15% in 2021/23, while three-in-one single-capsuleincreased from 0.3% in 2013/2015 to 20% in 2021/23. An increase in the average duration of treatments (from 9.8 days to 12.4 days) in 2013-2023 was identified, as well as in the use of standard/high-dose of PPIs (increasing from 36% to 60%) in 2013-2023. There was a ≈10% overall improvement in first-line mITT overall effectiveness from 86% to 94% in 11 years of evolution, both globally and in each geographic region (Table).

Table. Prescriptions and effectiveness trends of first-line empirical treatments in Europe in the period 2013-2023.
PPI: proton pump inhibitor; mITT: modified intention-to-treat; A – amoxicillin; C – clarithromycin; M – metronidazole; T – tinidazole; L – levofloxacin B; – bismuth salts; Tc – tetracycline; 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; *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.
Year	2013	2014	2015	2016	2017	2018	2019	2020	2021	2022	2023
Treatment Quadruple-C+A+B Single-capsule* Quadruple-M+Tc+B Concomitant-C+A+M/T Sequential-C+A+M/T Triple-A+L Triple-A+M Triple-C+M Triple-C+A	2.3% 0.2% 1.9% 19.4% 15.3% 2.1% 4.9% 3.2% 45.9%	3.2% 0.2% 1.7% 18.8% 9.1% 2.1% 4.3% 5.5% 50.3%	6.2% 0.5% 0.4% 23.9% 6.8% 2.9% 3.2% 7.2% 41.6%	18.5% 14.2% 0.2% 19.5% 1.8% 1.7% 2.9% 5.4% 29.0%	11.8% 21.0% 0.3% 17.8% 7.6% 0.6% 2.8% 1.2% 30.3%	24.8% 16.7% 0.6% 8.6% 7.1% 0.6% 0.5% 0.8% 30.3%	10.9% 20.7% 1.2% 11.8% 5.7% 1.2% 1.6% 1.1% 35.8%	13.1% 19.2% 1.3% 13.9% 3.5% 1.2% 1.0% 6.2% 31.9%	15.1% 18.6% 1.2% 14.6% 3.3% 1.4% 1.5% 3.8% 32.0%	14.0% 20.9% 3.1% 13.6% 3.5% 2.4% 2.6% 3.8% 26.4%	15.3% 20.4% 2.1% 16.6% 1.4% 3.4% 1.6% 2.9% 23.1%
Therapy length 7 days 10 days 14 days	27.6% 56.8% 15.7%	26.0% 55.8% 18.2%	22.0% 59.7% 18.3%	15.4% 50.0% 34.5%	7.2% 53.1% 39.7%	2.0% 46.4% 51.6%	2.7% 41.0% 56.3%	3.2% 38.2% 58.6%	2.8% 42.6% 54.6%	8.9% 43.7% 47.5%	3.6% 35.1% 61.3%
PPI doses** Low Standard High	64.4% 15.8% 19.9%	54.6% 22.9% 22.5%	45.6% 24.3% 30.1%	39.1% 22.6% 38.3%	43.8% 22.7% 33.5%	30.9% 37.0% 32.1%	34.6% 27.9% 37.5%	44.7% 23.5% 31.7%	41.5% 26.2% 32.3%	33.7% 36.0% 30.3%	40.4% 32.3% 27.3%
Overall effectiveness Eradication rate (mITT)	86.0%	85.9%	86.3%	87.7%	88.2%	90.3%	89.0%	89.6%	90.9%	91.9%	93.9%
Effectiveness depending on geographical region East East-Centre South-West West-Centre North	91.5% 87.4% 84.2% 88.7% 83.8%	80.5% 84.9% 86.8% 92.1% 84.4%	85.2% 85.2% 86.0% 92.9% 85.6%	82.9% 84.7% 89.8% 94.3% 86.5%	81.4% 86.1% 91.3% 89.1% 86.6%	91.3% 88.2% 90.6% 92.4% 77.5%	89.5% 89.6% 88.4% 91.4% 83.0%	92.0% 93.1% 86.1% 89.9% 82.5%	92.9% 91.5% 91.0% 88.3% 82.1%	91.5% 91.7% 93.5% 93.8% 83.7%	93.1% 95.4% 95.3% 92.5% 81.9%

Conclusion

European gastroenterological practice is constantly adapting to the newest published evidence and recommendations (reducing the use of triple therapies and increasing both the duration of treatment and the dose of PPIs), with a subsequent progressive improvement in overall effectiveness.

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.

TRENDS IN THE PRESCRIPTION OF ERADICATION TREATMENTS AND THEIR EFFECTIVENESS IN NAÏVE PATIENTS OVER 11 YEARS (2013-2023) IN EUROPE: DATA FROM THE EUROPEAN REGISTRY ON HELICOBACTER PYLORI MANAGEMENT (HP-EUREG)

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

5 Modern Hospital, Baku, Azerbaijan

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

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

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

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

11 Gastrocentr, Perm, Russian Federation

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

13 Østfold Hospital Trust, Grålum, Norway

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

15 Interni oddelek, Diagnostic Centre, Bled, Slovenia

16 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

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

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

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

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

21 First Clinical Medical Centre, Kovrov, Russian Federation

22 National Oncology Centre, Baku, Azerbaijan

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

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

25 Far Eastern State Medical University, Khabarovsk, Russian Federation

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

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

28 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

29 Universal Clinic Private Medical Center, Moscow, Russian Federation

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

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

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

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

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

Conference

UEG Week Vienna 2024

Topics

Stomach & H. Pylori

Submission format

Abstract

Session

H.pylori treatment: Part 2 (Posters)

Citation

United European Gastroenterology Journal 2024; 12 (Supplement 8)

Published

2024

Table 1. Prescriptions and effectiveness trends of first-line empirical treatments in Europe in the period 2013-2022 PPI: proton pump inhibitor; mITT: modified intention-to-treat; A – amoxicillin. C – clarithromycin; M – metronidazole; T – tinidazole; L – levofloxacin B; – bismuth salts; Tc – tetracycline. Three-in-one single-capsule containing metronidazole. tetracycline and bismuth; *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.
Year	2013	2014	2015	2016	2017	2018	2019	2020	2021	2022
Quadruple-C+A+B Single-capsule* Quadruple-M+Tc+B Concomitant-C+A+M/T Sequential-C+A+M/T Triple-A+L Triple-A+M Triple-C+M Triple-C+A	2.0% 0.1% 2.1% 21.8% 11.8% 2.3% 3.6% 3.4% 48.5%	2.7% 0.0% 1.9% 21.5% 3.5% 2.2% 3.0% 6.4% 54.6%	6.8% 0.5% 0.5% 27.0% 1.9% 3.1% 1.7% 8.8% 44.7%	20.5% 13.2% 0.2% 22.7% 0.9% 1.8% 0.8% 6.3% 29.2%	13.7% 24.5% 0.4% 20.9% 0.5% 0.3% 0.9% 1.4% 32.1%	21.7% 18.7% 0.5% 8.0% 0.7% 0.3% 0.5% 0.7% 31.0%	10.8% 21.7% 1.4% 13.4% 0.11% 0.4% 1.9% 1.1% 35.2%	9.8% 16.5% 1.2% 12.8% 0.1% 0.3% 0.7% 10.2% 34.6%	9.4% 18.2% 1.1% 13.1% 0.3% 0.4% 1.0% 4.9% 32.7%	10.3% 21.1% 1.5% 10.6% 2.8% 0.9% 1.6% 4.1% 29.9%
Therapy length
7 days 10 days 14 days	27.5% 55.1% 17.4%	28.1% 52.6% 19.3%	24.4% 55.1% 20.4%	16.2% 46.5% 37.3%	7.9% 47.2% 44.9%	1.7% 41.6% 56.7%	2.1% 34.7% 63.2%	4.5% 29.4% 66.1%	2.9% 34.1% 62.9%	9.5% 43.2% 47.3%
PPI doses
Low Standard High	66.6% 16.9% 16.5%	56.6% 25.5% 17.9%	47.3% 26.7% 26.0%	37.9% 24.1% 38.0%	39.7% 23.7% 36.6%	25.0% 41.3% 33.7%	30.1% 30.9% 39.0%	45.3% 19.5% 35.2%	40.5% 25.4% 33.8%	28.6% 36.7% 34.6%
Eradication rate (mITT)	85.0%	85.1%	85.7%	87.6%	87.7%	91.4%	91.5%	92.7%	92%	93%
Geographical región
East South-east South-west Centre North	89.7% 87.3% 83.4% 87.9% 84.6%	80.2% 85.1% 86.9% 93.0% 84.3%	85.3% 85.2% 86.2% 92.8% 86.4%	83.4% 84.2% 89.9% 95.2% 84.9%	77.7% 86.3% 91.1% 88.0% 87.2%	91.3% 88.0% 90.9% 91.9% 80.5%	90.4% 89.3% 87.7% 91.3% 89.8%	96.0% 89.7% 85.3% 89.4% 86.5%	96.4% 89.1% 91.5% 86.1% 82.1%	96.8% 92.0% 95.3% 90.1% 88.0%

Table. Prescriptions and effectiveness trends of first-line empirical treatments in Europe in the period 2013-2024.
Year	2013	2014	2015	2016	2017	2018	2019	2020	2021	2022	2023	2024
Treatment Quadruple-C+A+B Single-capsule* Quadruple-M+Tc+B Concomitant-C+A+M/T Sequential-C+A+M/T Triple-A+L Triple-A+M Triple-C+M Triple-C+A	1.9% 0.2% 2% 21% 16% 2.2% 3.4% 3.2% 46%	2.6% 0.2% 1.8% 21% 9.7% 2.1% 2.9% 6.1% 50%	6.5% 0.5% 0.5% 27% 7.4% 3% 1.5% 8.1% 40%	19% 14% 0.2% 21% 1.9% 1.7% 1.5% 5.7% 29%	12% 22% 0.3% 19% 7.8% 0.6% 1.3% 1.3% 30%	25% 17% 0.6% 8.5% 7.2% 0.6% 0.4% 0.9% 30%	13% 21% 1.3% 11% 5.8% 1.1% 1.6% 1.2% 36%	14% 19% 1.3% 13% 3.6% 1.2% 1% 6.4% 33%	16% 19% 1.6% 14% 3.6% 1.2% 1.3% 4.1% 33%	14% 21% 3.7% 13% 3.6% 2.3% 1.5% 3.9% 28%	17% 19% 2.4% 15% 2.4% 3% 1.6% 2.7% 25%	17% 20% 2.8% 14% 2.1% 2% 1.3% 1.7% 21%
Therapy length 7 days 10 days 14 days	27% 57% 17%	28% 55% 18%	23% 59% 18%	17% 48% 36%	7.3% 52% 40%	2.1% 47% 51%	2.8% 41% 51%	3.4% 39% 58%	2.9% 43% 54%	8.8% 43% 48%	3% 34% 63%	2.1% 31% 67%
PPI doses Low (4.5 to 27 mg omeprazole equivalents b.i.d.) Standard (32 to 40 mg omeprazole equivalents b.i.d.) High (54 to 128 mg omeprazole equivalents b.i.d.)	64% 16% 20%	55% 24% 22%	44% 24% 31%	38% 23% 39%	44% 23% 33%	31% 37% 32%	35% 29% 37%	46% 24% 30%	43% 26% 31%	37% 35% 29%	42% 31% 27%	39% 28% 33%
Overall effectiveness Eradication rate (mITT)	86%	85%	86%	88%	88%	91%	89%	89%	91%	92%	92%	93%
Effectiveness depending on geographical region East East-Centre South-West West-Centre North	92% 87% 84% 89% 85%	79% 85% 86% 92% 82%	84% 86% 86% 93% 83%	83% 85% 90% 94% 88%	82% 87% 91% 89% 83%	91% 89% 91% 92% 77%	90% 89% 88% 91% 84%	93% 93% 85% 89% 83%	93% 91% 90% 89% 81%	91% 92% 93% 94% 83%	93% 94% 92% 94% 77%	91% 95% 95% 94% 79%
PPI: proton pump inhibitor; mITT: modified intention-to-treat; A – amoxicillin; C – clarithromycin; M – metronidazole; T – tinidazole; L – levofloxacin B; – bismuth salts; Tc – tetracycline; East – Ukraine, Serbia, Bulgaria, Turkey, Russia, Romania, Albania, North Macedonia, Bosnia and Herzegovina, Kosovo, Moldova, Montenegro; East-Centre – Croatia, Poland, Hungary, Latvia, Lithuania, Greece, Slovenia, Czech Rep, Azerbaijan, Slovakia, Malta, Armenia; South-West – Portugal, Spain; West-Centre – France, Austria, Belgium, Germany, Italy; North – The United Kingdom, Finland, The Netherlands, Ireland, Israel, Norway, Switzerland, Sweden, Denmark; *Three-in-one single-capsule containing metronidazole. tetracycline and bismuth.

Table 1. Frequency of second-line empirical treatment prescriptions and effectiveness by modified intention-to-treat (mITT) and per-protocol (PP) analyses, by geographical region.
Treatment	N	Use (%)	mITT, N (%)	(95% CI)	PP, N (%)	(95% CI)
Triple-A+L Single-capsule* Quadruple-A+L+B Triple-C+A Quadruple-C+A+M Quadruple-M+Tc+B Quadruple-C+A+B Triple-A+R Triple-A+M Triple-A+Mx Other Total	2,096 1,518 945 436 423 399 329 208 193 143 973 7,663	27.4 19.8 12.3 5.7 5.5 5.2 4.3 2.7 2.5 1.9 12.7 100	1,867 (81) 1,417 (88) 751 (87) 338 (77) 396 (85) 356 (84)** 215 (89) 185 (83) 172 (64) 135 (91) NA 6,665 (83)	(79-83) (86-90) (85-90) (73-82) (81-88) (80-88) (84-93) (77-88) (57-72) (86-96) NA (82-84)	1,844 (81) 1,382 (89) 732 (88) 330 (77) 387 (85) 340 (86) 206 (89) 183 (83) 170(65) 135 (91) NA 6,523 (83)	(80-83) (87-90) (85-90) (72-82) (82-89) (82-90) (84-93) (77-89) (57-72) (86-96) NA (82-84)
East South-East South-West Centre North Total	1,183 1,345 3,808 974 565 7,875	15.0 17.1 48.4 12.4 7.2 100	928 (84) 945 (83) 3,609 (83) 855 (84) 497 (74) 6,834 (83)	(81-86) (81-86) (82-85) (81-86) (70-78) (82-84)	896 (84) 932 (84) 3,534 (84) 840 (84) 481 (75) 6,683 (83)	(81-86) (81-86) (83-85) (82-87) (71-79) (82-84)
95% CI –confidence interval, C – clarithromycin, M – metronidazole, A – amoxicillin, L – levofloxacin, B – bismuth salts, Tc – tetracycline, R – rifabutin, Mx – moxifloxacin, N – Total number of patients receiving an empirical treatment, Other – Other second-line empirical treatments with less than 100 patients treated in each category; three-in-one single capsule containing metronidazole tetracycline and bismuth; *achieved over 90% effectiveness when optimised (high-dose PPIs and 14-days length).

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