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-Santamaria, D.; Nyssen, O. P.; Gasbarrini, A.; Vaira, D.; Perez-Aisa, A.; Rodrigo, L.; Pellicano, R.; Keco-Huerga, A.; Pabon-Carrasco, M.; Castro-Fernandez, M.; Boltin, D.; Barrio, J.; Phull, P.; Kupcinskas, J.; Jonaitis, L.; Ortiz-Polo, I.; Tepes, B.; Lucendo, A. J.; Huguet, J. M.; Areia, M.; Jurecic, N. B.; Denkovski, M.; Bujanda, L.; Ramos-San Roman, J.; Cuadrado-Lavin, A.; Gomez-Camarero, J.; Jimenez Moreno, M. A.; Lanas, A.; Martinez-Dominguez, S. J.; Alfaro, E.; Marcos-Pinto, R.; Milivojevic, V.; Rokkas, T.; Leja, M.; Smith, S.; Tonkic, A.; Buzas, G. M.; Doulberis, M.; Venerito, M.; Lerang, F.; Bordin, D. S.; Lamy, V.; Capelle, L. G.; Marlicz, W.; Dobru, D.; Gridnyev, O.; Puig, I.; Megraud, F.; O'Morain, C.; Gisbert, J. P.; Alcaide, N.; Velayos, B.; Fernandez-Salazar, L.; Lasala, J. P.; Calvet, X.; Gomez Rodriguez, B. J.; Beales, I. L. P.; Dominguez-Cajal, M.; Perona, M.; Georgopoulos, S.; Compare, D.; Bumane, R.; Almela, P.; Nunez, O.; Marusic, M.; Botargues Bote, J. M.; Tejedor-Tejada, J.; Fernandez-Bermejo, M.; Voynovan, I.; De La Pena-Negro, L. C.; Ortega, X. S.; Gonzalez-Santiago, J. M.; Mcnamara, D.; Compare, D.; Villarroya, R. P.; Iyo, E.; Gomez, B.; Link, A.; Rosania, R.; Venerito, M.; Malfertheiner, P.; Kahraman, A.; Nunez, O.; Ghisa, M.; Dekhnich, N. N.; Nikolic, M.; Alcedo, J.; Iragorri, I. J.; Bermejo, F.; Algaba, A.; Campillo, A.; Abdulkhakov, R.; Grigorieva, L.; Fadeenko, G.; Da Silva, J. A.; Alekseenko, S.; Zaytsev, O.; Ilchishina, T.; Pakhomova, A.; Huguet-Malaves, J. M.; Amorena, E.; Belousova, L. N.; Plotnikova, E. Y.; Vologzhanina, L.; Bakanova, N.; Belousova, L. N.; Stovrag, T. N.; Nagorni, I.; Bjelakovic, M.

doi:10.1136/gutjnl-2022-328232

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.

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-Santamaria, D.; Nyssen, O. P.; Gasbarrini, A.; Vaira, D.; Perez-Aisa, A.; Rodrigo, L.; Pellicano, R.; Keco-Huerga, A.; Pabon-Carrasco, M.; Castro-Fernandez, M.; Boltin, D.; Barrio, J.; Phull, P.; Kupcinskas, J.; Jonaitis, L.; Ortiz-Polo, I.; Tepes, B.; Lucendo, A. J.; Huguet, J. M.; Areia, M.; Jurecic, N. B.; Denkovski, M.; Bujanda, L.; Ramos-San Roman, J.; Cuadrado-Lavin, A.; Gomez-Camarero, J.; Jimenez Moreno, M. A.; Lanas, A.; Martinez-Dominguez, S. J.; Alfaro, E.; Marcos-Pinto, R.; Milivojevic, V.; Rokkas, T.; Leja, M.; Smith, S.; Tonkic, A.; Buzas, G. M.; Doulberis, M.; Venerito, M.; Lerang, F.; Bordin, D. S.; Lamy, V.; Capelle, L. G.; Marlicz, W.; Dobru, D.; Gridnyev, O.; Puig, I.; Megraud, F.; O'Morain, C.; Gisbert, J. P.; Alcaide, N.; Velayos, B.; Fernandez-Salazar, L.; Lasala, J. P.; Calvet, X.; Gomez Rodriguez, B. J.; Beales, I. L. P.; Dominguez-Cajal, M.; Perona, M.; Georgopoulos, S.; Compare, D.; Bumane, R.; Almela, P.; Nunez, O.; Marusic, M.; Botargues Bote, J. M.; Tejedor-Tejada, J.; Fernandez-Bermejo, M.; Voynovan, I.; De La Pena-Negro, L. C.; Ortega, X. S.; Gonzalez-Santiago, J. M.; Mcnamara, D.; Compare, D.; Villarroya, R. P.; Iyo, E.; Gomez, B.; Link, A.; Rosania, R.; Venerito, M.; Malfertheiner, P.; Kahraman, A.; Nunez, O.; Ghisa, M.; Dekhnich, N. N.; Nikolic, M.; Alcedo, J.; Iragorri, I. J.; Bermejo, F.; Algaba, A.; Campillo, A.; Abdulkhakov, R.; Grigorieva, L.; Fadeenko, G.; Da Silva, J. A.; Alekseenko, S.; Zaytsev, O.; Ilchishina, T.; Pakhomova, A.; Huguet-Malaves, J. M.; Amorena, E.; Belousova, L. N.; Plotnikova, E. Y.; Vologzhanina, L.; Bakanova, N.; Belousova, L. N.; Stovrag, T. N.; Nagorni, I.; Bjelakovic, M.. - In: GUT. - ISSN 0017-5749. - 72:6(2023), pp. 1054-1072. [10.1136/gutjnl-2022-328232]