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2. 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)

Author

Burgos-Santamaría, Diego, Nyssen, Olga P, Gasbarrini, Antonio, Vaira, Dino, Pérez-Aisa, Ángele, Rodrigo, Luí, Pellicano, Rinaldo, Keco-Huerga, Alma, Pabón-Carrasco, Manuel, Castro-Fernandez, Manuel, Boltin, Doron, Barrio, Jesu, Phull, Perminder, Kupcinskas, Juoza, Jonaitis, Laima, Ortiz-Polo, Inmaculada, Tepes, Bojan, Lucendo, Alfredo J, Huguet, José María, Areia, Miguel, Jurecic, Natasa Brglez, Denkovski, Maja, Bujanda, Luí, Ramos-San Román, June, Cuadrado-Lavín, Antonio, Gomez-Camarero, Judith, Jiménez Moreno, Manuel Alfonso, Lanas, Angel, Martinez-Dominguez, Samuel Jesú, Alfaro, Enrique, Marcos-Pinto, Ricardo, Milivojevic, Vladimir, Rokkas, Theodore, Leja, Marci, Smith, Sinead, Tonkić, Ante, Buzás, György Mikló, Doulberis, Michael, Venerito, Marino, Lerang, Frode, Bordin, Dmitry S, Lamy, Vincent, Capelle, Lisette G, Marlicz, Wojciech, Dobru, Daniela, Gridnyev, Oleksiy, Puig, Ignasi, Mégraud, Franci, O'Morain, Colm, Gisbert, Javier P, Gasbarrini, Antonio (ORCID:0000-0002-7278-4823), Burgos-Santamaría, Diego, Nyssen, Olga P, Gasbarrini, Antonio, Vaira, Dino, Pérez-Aisa, Ángele, Rodrigo, Luí, Pellicano, Rinaldo, Keco-Huerga, Alma, Pabón-Carrasco, Manuel, Castro-Fernandez, Manuel, Boltin, Doron, Barrio, Jesu, Phull, Perminder, Kupcinskas, Juoza, Jonaitis, Laima, Ortiz-Polo, Inmaculada, Tepes, Bojan, Lucendo, Alfredo J, Huguet, José María, Areia, Miguel, Jurecic, Natasa Brglez, Denkovski, Maja, Bujanda, Luí, Ramos-San Román, June, Cuadrado-Lavín, Antonio, Gomez-Camarero, Judith, Jiménez Moreno, Manuel Alfonso, Lanas, Angel, Martinez-Dominguez, Samuel Jesú, Alfaro, Enrique, Marcos-Pinto, Ricardo, Milivojevic, Vladimir, Rokkas, Theodore, Leja, Marci, Smith, Sinead, Tonkić, Ante, Buzás, György Mikló, Doulberis, Michael, Venerito, Marino, Lerang, Frode, Bordin, Dmitry S, Lamy, Vincent, Capelle, Lisette G, Marlicz, Wojciech, Dobru, Daniela, Gridnyev, Oleksiy, Puig, Ignasi, Mégraud, Franci, O'Morain, Colm, Gisbert, Javier P, and Gasbarrini, Antonio (ORCID:0000-0002-7278-4823)

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.

Published
2022

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