• Adrian G McNicholl, Dmitry S Bordin, Alfredo Lucendo, Galina Fadeenko, Manuel Castro Fernandez, Irina Voynovan, Natalia Valerievna Zakharova, Aiman Silkanovna Sarsenbaeva, Luis Bujanda, Ángeles Perez-Aisa, Liudmila Vologzhanina, Oleg Zaytsev, Tatiana Ilchishina, Cristobal de la Coba, Jorge Perez Lasala, Sergey Alekseenko, Ines Modolell, Javier Molina-Infante, Rafael Ruiz-Zorrilla Lopez, Horacio Alonso-Galan, Nuria Fernandez Moreno, Jen Hinojosa, Inmaculada Santaella, Pilar Varela, Pedro Luis Gonzalez-Cordero, Jesus Barrio, Jose Luis Dominguez-Jimenez, Oscar Nuñez, Javier Alcedo, Olga P Nyssen, Maria Caldas, Maria G Donday, Oleg Shvetz, Francis Megraud, Colm O'Morain, and Javier P Gisbert.
• Gastroenterology Unit, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa, Universidad Autónoma de Madrid, and Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, Madrid, Spain.
• Clin. Gastroenterol. Hepatol. 2020 Jan 1; 18 (1): 89-98.

Background & AimsDue to the poor eradication rates of standard triple therapy, the addition of bismuth salts has been proposed for first-line eradication of Helicobacter pylori. We assessed the effectiveness and safety of the combination of bismuth and the standard, clarithromycin-containing triple therapy in eradication of H pylori infection, using data from a large multi-center registry.MethodsWe performed an interim analysis of data from the European Registry on H pylori Management, a prospective trial registering clinical data and outcomes from infected patients from 27 countries in Europe since 2013. We extracted data on 1141 treatment-naïve patients who received first-line treatment with bismuth salts (240 mg) and a proton pump inhibitor (57% received esomeprazole, 18% received omeprazole, 11% received pantoprazole, and 14% received rabeprazole), amoxicillin (1 g), and clarithromycin (500 mg), all taken twice daily.ResultsIntention to treat and per-protocol rates of eradication were 88% and 94%, respectively. Intention to treat eradication increased to 93% in patients who received 14-day treatments. Adverse events occurred in 36% of patients; 76% of these events were mild, with a mean duration of 6 days. In multivariate analysis, eradication was associated with treatment compliance (odds ratio [OR], 13.0), a double dose (equivalent to 40 mg omeprazole) of proton pump inhibitor (OR, 4.7), and 14-day duration of treatment (OR, 2.0).ConclusionsIn an analysis of data from a large multi-center registry, we found the addition of bismuth to 14-day standard triple therapy with clarithromycin and amoxicillin to eradicate H pylori infection in more than 90% of patients, based on intention to treat analysis, with an acceptable safety profile and level of adherence. ClinicalTrials.gov no: NCT02328131.Copyright © 2020 AGA Institute. Published by Elsevier Inc. All rights reserved.

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