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 Asociacion Espanola de Gastroenterologia-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 & GE;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.
Burgos-Santamaría, D., Nyssen, O. P., 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, A. J., Huguet, J. M., Areia, M., Jurecic, N. B., Denkovski, M., Bujanda, L., Ramos-San Román, J., Cuadrado-Lavín, A., Gomez-Camarero, J., Jiménez Moreno, M. A., Lanas, A., Martinez-Dominguez, S. J., Alfaro, E., Marcos-Pinto, R., Milivojevic, V., Rokkas, T., Leja, M., Smith, S., Tonkić, A., Buzás, G. M., Doulberis, M., Venerito, M., Lerang, F., Bordin, D. S., Lamy, V., Capelle, L. G., Marlicz, W., Dobru, D., Gridnyev, O., Puig, I., Mégraud, F., O'Morain, C., Gisbert, J. P., 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), <<EGUT>>, N/A; 72 (6): 1054-1072. [doi:10.1136/gutjnl-2022-328232] [https://hdl.handle.net/10807/241368]
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)
Gasbarrini, Antonio;
2022
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 Asociacion Espanola de Gastroenterologia-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 & GE;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.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.