Adrian G McNicholl1, Dmitry S Bordin2, Alfredo Lucendo3, Galina Fadeenko4, Manuel Castro Fernandez5, Irina Voynovan6, Natalia Valerievna Zakharova7, Aiman Silkanovna Sarsenbaeva8, Luis Bujanda9, Ángeles Perez-Aisa10, Liudmila Vologzhanina11, Oleg Zaytsev12, Tatiana Ilchishina13, Cristobal de la Coba14, Jorge Perez Lasala15, Sergey Alekseenko16, Ines Modolell17, Javier Molina-Infante18, Rafael Ruiz-Zorrilla Lopez19, Horacio Alonso-Galan9, Nuria Fernandez Moreno10, Jen Hinojosa10, Inmaculada Santaella10, Pilar Varela14, Pedro Luis Gonzalez-Cordero18, Jesus Barrio20, Jose Luis Dominguez-Jimenez21, Oscar Nuñez22, Javier Alcedo23, Olga P Nyssen1, Maria Caldas1, Maria G Donday1, Oleg Shvetz24, Francis Megraud25, Colm O'Morain26, Javier P Gisbert27. 1. 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. 2. Department of Pancreatobiliary and Upper GI Diseases, Moscow Clinical Scientific Center, Moscow, Russia. 3. Department of Gastroenterology, Hospital General de Tomelloso and Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, Tomelloso, Spain. 4. Digestive Ukrainian Academy of Medical Sciences, Kyiv, Ukraine. 5. Digestive Unit, Hospital de Valme, Sevilla, Spain. 6. Digestive Unit, Moscow Clinical Scientific Center Named After A.S. Loginov, Moscow, Russia. 7. North-western State Medical University St Petersburg, Russia. 8. Gastroenterologist Department of Regional Clinical Hospital №3, Chelyabinsk, Russia. 9. Department of Gastroenterology, Hospital Donostia/Instituto Biodonostia, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, Universidad del País Vasco, San Sebastián, Spain. 10. Digestive Unit, Agencia Sanitaria Costa del Sol, Marbella, Spain. 11. Gastroenterology Unit Gastrocentr, Perm, Russia. 12. First Clinical Medical Centre, Kovrov, Russia. 13. SM-Clinic, Saint-Petersburg, Russia. 14. Hospital de Cabueñes, Asturias, Spain. 15. Digestive Service, HM Sanchinarro, Madrid, Spain. 16. Far Eastern State Medical University, Khabarovsk, Khabarovsk Krai, Russia. 17. Consorci Sanitari de Terrassa, Barcelona, Spain. 18. Hospital San Pedro de Alcántara and CIBEREHD, Cáceres, Spain. 19. Hospital de Sierrallana, Torrelavega, Spain. 20. Gastroenterology Unit, Rio Hortega University Hospital, Valladolid, Spain. 21. Gastroenterology Unit, Hospital Alto Guadalquivir, Jaen, Spain. 22. Gastroenterology Unit, Clinica Nuestra Señora del Rosario, Madrid, Spain. 23. Gastroenterology Unit, Hospital de Barbastro, Huesca, Spain. 24. Medical University, Kyiv, Ukraine. 25. Laboratoire de Bactériologie, Hôpital Pellegrin, Bordeaux, France. 26. Department of Clinical Medicine, Trinity College Dublin, Dublin, Ireland. 27. 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. Electronic address: javier.p.gisbert@gmail.com.
Abstract
BACKGROUND & AIMS: Due 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. METHODS: We 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. RESULTS: Intention 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). CONCLUSIONS: In 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.
BACKGROUND & AIMS: Due 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. METHODS: We performed an interim analysis of data from the European Registry on H pylori Management, a prospective trial registering clinical data and outcomes from infectedpatients 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. RESULTS: Intention 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). CONCLUSIONS: In 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.
Authors: María Caldas; Ángeles Pérez-Aisa; Manuel Castro-Fernández; Luis Bujanda; Alfredo J Lucendo; Luis Rodrigo; Jose M Huguet; Jorge Pérez-Lasala; Javier Molina-Infante; Jesús Barrio; Luis Fernández-Salazar; Ángel Lanas; Mónica Perona; Manuel Domínguez-Cajal; Juan Ortuño; Blas José Gómez-Rodríguez; Pedro Almela; Josep María Botargués; Óscar Núñez; Inés Modolell; Judith Gómez; Rafael Ruiz-Zorrilla; Cristóbal De la Coba; Alain Huerta; Eduardo Iyo; Liliana Pozzati; Rosario Antón; Mercé Barenys; Teresa Angueira; Miguel Fernández-Bermejo; Ana Campillo; Javier Alcedo; Ramón Pajares-Villaroya; Marianela Mego; Fernando Bermejo; José Luis Dominguez-Jiménez; Llúcia Titó; Nuria Fernández; Manuel Pabón-Carrasco; Ángel Cosme; Pilar Mata-Romero; Noelia Alcaide; Inés Ariño; Tommaso Di Maira; Ana Garre; Ignasi Puig; Olga P Nyssen; Francis Megraud; Colm O'Morain; Javier P Gisbert Journal: Antibiotics (Basel) Date: 2020-12-25