NYSSEN, O. P., D. VAIRA, Á. PÉREZ AÍSA, L. RODRIGO, M. CASTRO-FERNANDEZ, L. JONAITIS, B. TEPES, L. VOLOGZHANINA, M. CALDAS, A. LANAS, A. J. LUCENDO, L. BUJANDA, J. ORTUÑO, J. BARRIO, J. M. HUGUET, I. VOYNOVAN, J. P. LASALA, A. S. SARSENBAEVA, L. FERNANDEZ-SALAZAR, J. MOLINA-INFANTE, N. B. JURECIC, M. AREIA, A. GASBARRINI, J. KUPČINSKAS, D. BORDIN, R. MARCOS-PINTO, F. LERAND, M. LEJA, G. M. BUZAS, Y. NIV, T. ROKKAS, P. PHULL, S. SMITH, O. SHVETS, M. VENERITO, V. MILIVOJEVIC, I. SIMSEK, V. LAMY, P. BYTZER, L. BOYANOVA, Lumír KUNOVSKÝ, C. BEGLINGER, M. DOULBERIS, W. MARLICZ, A. GOLDIS, A. TONKIĆ, L. CAPELLE, I. PUIG, F. MEGRAUD, C. O. MORAIN and J. P. GISBERT. Empirical Second-Line Therapy in 5000 Patients of the European Registry on Helicobacter pylori Management (Hp-EuReg). Clinical Gastroenterology and Hepatology. New York: Elsevier, 2022, vol. 20, No 10, p. 2243-2257. ISSN 1542-3565. Available from: https://dx.doi.org/10.1016/j.cgh.2021.12.025.
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Basic information
Original name Empirical Second-Line Therapy in 5000 Patients of the European Registry on Helicobacter pylori Management (Hp-EuReg)
Authors NYSSEN, O. P. (guarantor), D. VAIRA, Á. PÉREZ AÍSA, L. RODRIGO, M. CASTRO-FERNANDEZ, L. JONAITIS, B. TEPES, L. VOLOGZHANINA, M. CALDAS, A. LANAS, A. J. LUCENDO, L. BUJANDA, J. ORTUÑO, J. BARRIO, J. M. HUGUET, I. VOYNOVAN, J. P. LASALA, A. S. SARSENBAEVA, L. FERNANDEZ-SALAZAR, J. MOLINA-INFANTE, N. B. JURECIC, M. AREIA, A. GASBARRINI, J. KUPČINSKAS, D. BORDIN, R. MARCOS-PINTO, F. LERAND, M. LEJA, G. M. BUZAS, Y. NIV, T. ROKKAS, P. PHULL, S. SMITH, O. SHVETS, M. VENERITO, V. MILIVOJEVIC, I. SIMSEK, V. LAMY, P. BYTZER, L. BOYANOVA, Lumír KUNOVSKÝ (203 Czech Republic, belonging to the institution), C. BEGLINGER, M. DOULBERIS, W. MARLICZ, A. GOLDIS, A. TONKIĆ, L. CAPELLE, I. PUIG, F. MEGRAUD, C. O. MORAIN and J. P. GISBERT.
Edition Clinical Gastroenterology and Hepatology, New York, Elsevier, 2022, 1542-3565.
Other information
Original language English
Type of outcome Article in a journal
Field of Study 30219 Gastroenterology and hepatology
Country of publisher United States of America
Confidentiality degree is not subject to a state or trade secret
WWW URL
Impact factor Impact factor: 12.600
RIV identification code RIV/00216224:14110/22:00125477
Organization unit Faculty of Medicine
Doi http://dx.doi.org/10.1016/j.cgh.2021.12.025
UT WoS 000899945100018
Keywords in English Bismuth; Helicobacter pylori; Clarithromycin; Levofloxacin; Rescue
Tags 14110213, 14110223, rivok
Tags International impact, Reviewed
Changed by Changed by: Mgr. Tereza Miškechová, učo 341652. Changed: 9/2/2023 08:31.
Abstract
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.
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