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

Authors	NYSSEN O. P. VAIRA D. PÉREZ AÍSA Á. 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. KUPČINSKAS J. BORDIN D. MARCOS-PINTO R. LERAND 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. KUNOVSKÝ Lumír BEGLINGER C. DOULBERIS M. MARLICZ W. GOLDIS A. TONKIĆ A. CAPELLE L. PUIG I. MEGRAUD F. MORAIN C. O. GISBERT J. P.
Year of publication	2022
Type	Article in Periodical
Magazine / Source	Clinical Gastroenterology and Hepatology
MU Faculty or unit	Faculty of Medicine
Citation
Web	https://www.sciencedirect.com/science/article/abs/pii/S1542356521013495?via%3Dihub
Doi	http://dx.doi.org/10.1016/j.cgh.2021.12.025
Keywords	Bismuth; Helicobacter pylori; Clarithromycin; Levofloxacin; Rescue
Description	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.