Empirical rescue treatment of Helicobacter pylori infection in third and subsequent lines: 8-year experience in 2144 patients from the European Registry on H. pylori management (Hp-EuReg)

Burgos-Santamaría D, Nyssen OP, Gasbarrini A, Vaira D, Pérez-Aisa Á, Rodrigo L, Pellicano R, Keco-Huerga A, Pabón-Carrasco M, Castro-Fernandez M, Boltin D, Barrio J, Phull P, Kupcinskas J, Jonaitis L, Ortiz-Polo I, Tepes B, Lucendo AJ, Huguet JM, Areia M, Jurecic NB, Denkovski M, Bujanda L, Ramos-San Román J, Cuadrado-Lavín A, Gomez-Camarero J, Jiménez Moreno MA, Lanas A, Martinez-Dominguez SJ, Alfaro E, Marcos-Pinto R, Milivojevic V, Rokkas T, Leja M, Smith S, Tonkić A, Buzás GM, Doulberis M, Lerang F, Bordin DS, Lamy V, Capelle LG, Marlicz W, Dobru D, Gridnyev O, Puig I, Mégraud F, O'Morain C, Gisbert JP, Alcaide N, Velayos B, Fernández-Salazar L, Lasala JP, Calvet X, Gómez Rodríguez BJ, Beales IL, Domínguez-Cajal M, Perona M, Georgopoulos S, Bumane R, Almela P, Marusic M, Botargues Bote JM, Tejedor-Tejada J, Fernandez-Bermejo M, Voynovan I, De La Peña-Negro LC, Ortega XS, González-Santiago JM, McNamara D, Compare D, Villarroya RP, Iyo E, Gómez B, Link A, Rosania R, Venerito M, Malfertheiner P, Kahraman A, Núñez Ó, Ghisa M, Dekhnich NN, Nikolic M, Alcedo J, Iragorri IJ, Bermejo F, Algaba A, Campillo A, Abdulkhakov R, Grigorieva L, Fadeenko G, Da Silva JA, Alekseenko S, Zaytsev O, Ilchishina T, Pakhomova A, Huguet-Malavés JM, Amorena E, Belousova LN, Plotnikova EY, Vologzhanina L, Bakanova N, Belousova LN, Stovrag TN, Nagorni I, Bjelakovic M (2023)

Publication Type: Journal article

Publication year: 2023

Journal

Book Volume: 72

Pages Range: 1054-1072

Journal Issue: 6

DOI: 10.1136/gutjnl-2022-328232

Abstract

Objective To evaluate the use, effectiveness and safety of Helicobacter pylori empirical rescue therapy in third and subsequent treatment lines in Europe. Design International, prospective, non-interventional registry of the clinical practice of European gastroenterologists. Data were collected and quality reviewed until October 2021 at Asociación Española de Gastroenterología-Research Electronic Data Capture. All cases with three or more empirical eradication attempts were assessed for effectiveness by modified intention-to-treat and per-protocol analysis. Results Overall, 2144 treatments were included: 1519, 439, 145 and 41 cases from third, fourth, fifth and sixth treatment lines, respectively. Sixty different therapies were used; the 15 most frequently prescribed encompassed >90% of cases. Overall effectiveness remained <90% in all therapies. Optimised treatments achieved a higher eradication rate than non-optimised (78% vs 67%, p<0.0001). From 2017 to 2021, only 44% of treatments other than 10-day single-capsule therapy used high proton-pump inhibitor doses and lasted ≥14 days. Quadruple therapy containing metronidazole, tetracycline and bismuth achieved optimal eradication rates only when prescribed as third-line treatment, either as 10-day single-capsule therapy (87%) or as 14-day traditional therapy with tetracycline hydrochloride (95%). Triple amoxicillin-levofloxacin therapy achieved 90% effectiveness in Eastern Europe only or when optimised. The overall incidence of adverse events was 31%. Conclusion Empirical rescue treatment in third and subsequent lines achieved suboptimal effectiveness in most European regions. Only quadruple bismuth-metronidazole-tetracycline (10-day single-capsule or 14-day traditional scheme) and triple amoxicillin-levofloxacin therapies reached acceptable outcomes in some settings. Compliance with empirical therapy optimisation principles is still poor 5 years after clinical practice guidelines update. Trial registration number NCT02328131.

Involved external institutions

Tel Aviv University Israel (IL) Hospital Universitario y Politécnico de La Fe Spain (ES) Hospital Geral de Santo António Portugal (PT) Fondazione Policlinico Universitario Agostino Gemelli IRCCS Italy (IT) George Emil Palade University of Medicine, Pharmacy, Science, and Technology of Târgu Mureş / Universitatea de Medicină, Farmacie, Științe și Tehnologie „George Emil Palade” din Târgu Mureș Romania (RO) Central University Hospital of Asturias Spain (ES) Trinity College Dublin Ireland (IE) Université de Bordeaux France (FR) Diagnostic Centre Bled / Diagnostični center Bled Slovenia (SI) National Academy of Medical Sciences of Ukraine (NAMS) / NAMS Ukraine Ukraine (UA) Pomeranian Medical University / Pomorski Uniwersytet Medyczny w Szczecinie (PMU) Poland (PL) Marqués de Valdecilla University Hospital / Hospital Universitario de Marqués de Valdecilla (HUMV) Spain (ES) Hospital Universitario Ramón y Cajal Spain (ES) Complejo Asistencial Universitario de Burgos Spain (ES) Instituto Português de Oncologia Francisco Gentil (IPO) / Portuguese Oncology Institute Portugal (PT) Hospital Clínico Universitario Lozano Blesa Spain (ES) Henry Dunant Hospital / Errikos Dunant Hospital Center / Ερρίκος Ντυνάν Hospital Center Greece (GR) Fundació Althaia Spain (ES) Hospital Universitario Rio Hortega Spain (ES) Kantonsspital Aarau AG Switzerland (CH) Aberdeen Royal Infirmary (ARI) United Kingdom (GB) Donostia University Hospital / Donostia Unibertsitate Ospitalea Spain (ES) University Clinical Centre of Serbia / Univerzitetski Klinički Centar Srbije / Универзитетски клинички центар Србије Serbia (RS) Ferencváros Health Center Hungary (HU) University of Bologna / Università di Bologna Italy (IT) Lithuanian University of Health Sciences / Lietuvos sveikatos mokslų universitetas (LSMU) Lithuania (LT) Østfold Hospital Trust / Sykehuset Østfold Norway (NO) University of Turin / Università degli Studi di Torino (UNITO) Italy (IT) Hospital General Universitari de València Spain (ES) Public General Hospital Tomelloso / Hospital General de Tomelloso Spain (ES) Digestive Diseases Centre GASTRO / Gremošanas slimību centrs GASTRO Latvia (LV) University Hospital Split Croatia (HR) Erasmus University Medical Center (MC) Netherlands (NL) Hospital Universitario Virgen de Valme Spain (ES) GBUZ Moscow Clinical Scientific Center Russian Federation (RU) CHU Charleroi Belgium (BE) Otto-von-Guericke-Universität Magdeburg Germany (DE) Hospital Universitario de La Princesa Spain (ES) Hospital Costa del Sol Spain (ES)

How to cite

APA:

Burgos-Santamaría, D., Nyssen, O.P., Gasbarrini, A., Vaira, D., Pérez-Aisa, Á., Rodrigo, L.,... Bjelakovic, M. (2023). Empirical rescue treatment of Helicobacter pylori infection in third and subsequent lines: 8-year experience in 2144 patients from the European Registry on H. pylori management (Hp-EuReg). Gut, 72(6), 1054-1072. https://doi.org/10.1136/gutjnl-2022-328232

MLA:

Burgos-Santamaría, Diego, et al. "Empirical rescue treatment of Helicobacter pylori infection in third and subsequent lines: 8-year experience in 2144 patients from the European Registry on H. pylori management (Hp-EuReg)." Gut 72.6 (2023): 1054-1072.

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