Combination of Bismuth and Standard Triple Therapy Eradicates Helicobacter pylori Infection in More than 90% of Patients. McNicholl, A. G.; Bordin, D. S.; Lucendo, A.; Fadeenko, G.; Fernandez, M. C.; Voynovan, I.; Zakharova, N. V.; Sarsenbaeva, A. S.; Bujanda, L.; Perez-Aisa, Á.; Vologzhanina, L.; Zaytsev, O.; Ilchishina, T.; Coba, C. d. l.; Lasala, J. P.; Alekseenko, S.; Modolell, I.; Molina-Infante, J.; Ruiz-Zorrilla Lopez, R.; Alonso-Galan, H.; Moreno, N. F.; Hinojosa, J.; Santaella, I.; Varela, P.; Gonzalez-Cordero, P. L.; Barrio, J.; Dominguez-Jimenez, J. L.; Nuñez, O.; Alcedo, J.; Nyssen, O. P.; Caldas, M.; Donday, M. G.; Shvetz, O.; Megraud, F.; O'Morain, C.; and Gisbert, J. P. Clinical Gastroenterology and Hepatology: The Official Clinical Practice Journal of the American Gastroenterological Association, 18(1):89–98, 2020.
doi  abstract   bibtex   
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.
@article{mcnicholl_combination_2020,
	title = {Combination of {Bismuth} and {Standard} {Triple} {Therapy} {Eradicates} {Helicobacter} pylori {Infection} in {More} than 90\% of {Patients}},
	volume = {18},
	issn = {1542-7714},
	doi = {10.1016/j.cgh.2019.03.048},
	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.},
	language = {eng},
	number = {1},
	journal = {Clinical Gastroenterology and Hepatology: The Official Clinical Practice Journal of the American Gastroenterological Association},
	author = {McNicholl, Adrian G. and Bordin, Dmitry S. and Lucendo, Alfredo and Fadeenko, Galina and Fernandez, Manuel Castro and Voynovan, Irina and Zakharova, Natalia Valerievna and Sarsenbaeva, Aiman Silkanovna and Bujanda, Luis and Perez-Aisa, Ángeles and Vologzhanina, Liudmila and Zaytsev, Oleg and Ilchishina, Tatiana and Coba, Cristobal de la and Lasala, Jorge Perez and Alekseenko, Sergey and Modolell, Ines and Molina-Infante, Javier and Ruiz-Zorrilla Lopez, Rafael and Alonso-Galan, Horacio and Moreno, Nuria Fernandez and Hinojosa, Jen and Santaella, Inmaculada and Varela, Pilar and Gonzalez-Cordero, Pedro Luis and Barrio, Jesus and Dominguez-Jimenez, Jose Luis and Nuñez, Oscar and Alcedo, Javier and Nyssen, Olga P. and Caldas, Maria and Donday, Maria G. and Shvetz, Oleg and Megraud, Francis and O'Morain, Colm and Gisbert, Javier P.},
	year = {2020},
	pmid = {30978536},
	keywords = {Antimicrobial, Article, Bacteria, Database, Digestiu, Hp-EuReg, Medicina Interna, Optimized Treatment, PPI},
	pages = {89--98},
}
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