Empirical Second-Line Therapy in 5000 Patients of the European Registry on Helicobacter pylori Management (Hp-EuReg)

Nyssen, O. P.; Vaira, D.; Perez Aisa, A.; Rodrigo, L.; Castro-Fernandez, M.; Jonaitis, L.; Tepes, B.; Vologzhanina, L.; Caldas, M.; Lanas, A.; Lucendo, A. J.; Bujanda, L.; Ortuno, J.; Barrio, J.; Huguet, J. M.; Voynovan, I.; Lasala, J. P.; Sarsenbaeva, A. S.; Fernandez-Salazar, L.; Molina-Infante, J.; Jurecic, N. B.; Areia, M.; Gasbarrini, Antonio; Kupcinskas, J.; Bordin, D.; Marcos-Pinto, R.; Lerang, F.; Leja, M.; Buzas, G. M.; Niv, Y.; Rokkas, T.; Phull, P.; Smith, S.; Shvets, O.; Venerito, M.; Milivojevic, V.; Simsek, I.; Lamy, V.; Bytzer, P.; Boyanova, L.; Kunovsky, L.; Beglinger, C.; Doulberis, M.; Marlicz, W.; Goldis, A.; Tonkic, A.; Capelle, L.; Puig, I.; Megraud, F.; Morain, C. O.; Gisbert, J. P.; Fiorinni, G.; Saracino, I. M.; Carrasco, M. P.; Huerga, A. K.; Almajano, E. A.; Martinez Dominguez, S. J.; Galan, H. A.; Velayos, B.; Sadornil, C. D.; Botargues Bote, J. M.; Gonzalez-Cordero, P. L.; Gomez Rodriguez, B. J.; Pellicano, R.; Nunez, O.; Franceschi, Francesco; Alekseenko, S.; Perona, M.; Abdulkhakov, R.; Dominguez-Cajal, M.; Notari, P. A.; Camarero, J. G.; Moreno, M. J.; Algaba, A.; Bermejo, F.; Tejada, J. T.; Susanibar, E. O.; Boltin, D.; Georgopoulos, S.; Omorain, C.; Qasim, A.; Beales, I.; Bakulina, N.; Fadeenko, G.; Malfertheiner, P.; Rosania, R.; Ilchishina, T.; Bogomolov, P.; Bakulin, I.; Zaytsev, O.; Gravina, A. G.; Romano, M.; Di Leo, A.; Losurdo, G.; Grigorieva, L.; Guillena, P. D.; Marusic, M.; Jurcic, D.; Dekhnich, N. N.; Iyo, E.; de la Pena Negro, L. C.; Baryshnikova, N.; Bakanova, N.; Simsek, H.; Simsek, C.; Gridnyev, O.; Fernandez-Bermejo, M.; Angueira, T.; Ruiz-Zorrilla Lopez, R.; Gomez, B.; Kovacheva-Slavova, M.; Lahat, A.; Alcedo, J.; Campillo, A.; Belousova, L. N.; Villarroya, R. P.; Ljubicic, N.; Nikolic, M.; Gonzalez-Santiago, J. M.; Santamaria, D. B.; Pakhomova, A.; Sekulic-Spasic, I.; Ghisa, M.; Farinati, F.; Sagdati, S. I.; Panic, N.; Heluwaert, F.; Amorena, E.; Moreira, L.; Esparrach, G. F.; Plotnikova, E. Y.; Kukla, M.; Kamburov, V.; Lamuela Calvo, L. J.; Rankovic, I.; Lavin, A. C.; Lazaro, Y. A.; Carrera Agnieszka Dobrowolska, V. G.; Eder, P.; Kononova, A.

doi:10.1016/j.cgh.2021.12.025

Background & Aims: After a first Helicobacter pylori eradication attempt, approximately 20% of patients will remain infected. The aim of the current study was to assess the effectiveness and safety of second-line empiric treatment in Europe. Methods: This international, multicenter, prospective, non-interventional registry aimed to evaluate the decisions and outcomes of H pylori management by European gastroenterologists. All infected adult cases with a previous eradication treatment attempt were registered with the Spanish Association of Gastroenterology–Research Electronic Data Capture until February 2021. Patients allergic to penicillin and those who received susceptibility-guided therapy were excluded. Data monitoring was performed to ensure data quality. Results: Overall, 5055 patients received empiric second-line treatment. Triple therapy with amoxicillin and levofloxacin was prescribed most commonly (33%). The overall effectiveness was 82% by modified intention-to-treat analysis and 83% in the per-protocol population. After failure of first-line clarithromycin-containing treatment, optimal eradication (>90%) was obtained with moxifloxacin-containing triple therapy or levofloxacin-containing quadruple therapy (with bismuth). In patients receiving triple therapy containing levofloxacin or moxifloxacin, and levofloxacin–bismuth quadruple treatment, cure rates were optimized with 14-day regimens using high doses of proton pump inhibitors. However, 3-in-1 single capsule or levofloxacin–bismuth quadruple therapy produced reliable eradication rates regardless of proton pump inhibitor dose, duration of therapy, or previous first-line treatment. The overall incidence of adverse events was 28%, and most (85%) were mild. Three patients developed serious adverse events (0.3%) requiring hospitalization. Conclusions: Empiric second-line regimens including 14-day quinolone triple therapies, 14-day levofloxacin–bismuth quadruple therapy, 14-day tetracycline–bismuth classic quadruple therapy, and 10-day bismuth quadruple therapy (as a single capsule) provided optimal effectiveness. However, many other second-line treatments evaluated reported low eradication rates. ClincialTrials.gov number: NCT02328131.

Nyssen, O. P., Vaira, D., Perez Aisa, A., Rodrigo, L., Castro-Fernandez, M., Jonaitis, L., Tepes, B., Vologzhanina, L., Caldas, M., Lanas, A., Lucendo, A. J., Bujanda, L., Ortuno, J., Barrio, J., Huguet, J. M., Voynovan, I., Lasala, J. P., Sarsenbaeva, A. S., Fernandez-Salazar, L., Molina-Infante, J., Jurecic, N. B., Areia, M., Gasbarrini, A., Kupcinskas, J., Bordin, D., Marcos-Pinto, R., Lerang, F., Leja, M., Buzas, G. M., Niv, Y., Rokkas, T., Phull, P., Smith, S., Shvets, O., Venerito, M., Milivojevic, V., Simsek, I., Lamy, V., Bytzer, P., Boyanova, L., Kunovsky, L., Beglinger, C., Doulberis, M., Marlicz, W., Goldis, A., Tonkic, A., Capelle, L., Puig, I., Megraud, F., Morain, C. O., Gisbert, J. P., Fiorinni, G., Saracino, I. M., Carrasco, M. P., Huerga, A. K., Almajano, E. A., Martinez Dominguez, S. J., Galan, H. A., Velayos, B., Sadornil, C. D., Botargues Bote, J. M., Gonzalez-Cordero, P. L., Gomez Rodriguez, B. J., Pellicano, R., Nunez, O., Franceschi, F., Alekseenko, S., Perona, M., Abdulkhakov, R., Dominguez-Cajal, M., Notari, P. A., Camarero, J. G., Moreno, M. J., Algaba, A., Bermejo, F., Tejada, J. T., Susanibar, E. O., Boltin, D., Georgopoulos, S., Omorain, C., Qasim, A., Beales, I., Bakulina, N., Fadeenko, G., Malfertheiner, P., Rosania, R., Ilchishina, T., Bogomolov, P., Bakulin, I., Zaytsev, O., Gravina, A. G., Romano, M., Di Leo, A., Losurdo, G., Grigorieva, L., Guillena, P. D., Marusic, M., Jurcic, D., Dekhnich, N. N., Iyo, E., De La Pena Negro, L. C., Baryshnikova, N., Bakanova, N., Simsek, H., Simsek, C., Gridnyev, O., Fernandez-Bermejo, M., Angueira, T., Ruiz-Zorrilla Lopez, R., Gomez, B., Kovacheva-Slavova, M., Lahat, A., Alcedo, J., Campillo, A., Belousova, L. N., Villarroya, R. P., Ljubicic, N., Nikolic, M., Gonzalez-Santiago, J. M., Santamaria, D. B., Pakhomova, A., Sekulic-Spasic, I., Ghisa, M., Farinati, F., Sagdati, S. I., Panic, N., Heluwaert, F., Amorena, E., Moreira, L., Esparrach, G. F., Plotnikova, E. Y., Kukla, M., Kamburov, V., Lamuela Calvo, L. J., Rankovic, I., Lavin, A. C., Lazaro, Y. A., Carrera Agnieszka Dobrowolska, V. G., Eder, P., Kononova, A., Empirical Second-Line Therapy in 5000 Patients of the European Registry on Helicobacter pylori Management (Hp-EuReg), <<CLINICAL GASTROENTEROLOGY AND HEPATOLOGY>>, 2022; 20 (10): 2243-2257. [doi:10.1016/j.cgh.2021.12.025] [https://hdl.handle.net/10807/302072]