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.. - In: GUT. - ISSN 0017-5749. - ELETTRONICO. - 72:6(2022), pp. 328232.1054-328232.1072. [10.1136/gutjnl-2022-328232]

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)

Vaira D.;
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 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.
2022
GUT
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.. - In: GUT. - ISSN 0017-5749. - ELETTRONICO. - 72:6(2022), pp. 328232.1054-328232.1072. [10.1136/gutjnl-2022-328232]
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.
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11585/937443
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