Empirical rescue treatment of Helicobacter pylori infection in third and subsequent lines: 8-year experience in 2144 patients from the European Registry on H. pylori management (Hp-EuReg).

Autor: Burgos-Santamaría D; Department of Gastroenterology and Hepatology, Hospital Universitario Ramón y Cajal, Madrid, Spain diegoburgossantamaria@gmail.com.; Enfermedades Hepáticas y Digestivas, Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS), Madrid, Spain., Nyssen OP; Gastroenterology Unit, Hospital Universitario de la Princesa, Madrid, Spain.; Instituto de Investigación Sanitaria Princesa (IIS-Princesa), Madrid, Spain.; Universidad Autónoma de Madrid (UAM), Madrid, Spain.; Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Madrid, Spain., Gasbarrini A; Internal Medicine, Gastroenterology and Liver Unit, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma, Italy.; Università Cattolica del Sacro Cuore Facoltà di Medicina e Chirurgia, Roma, Italy., Vaira D; Department of Medical and Surgical Sciences, University of Bologna, Bologna, Italy., Pérez-Aisa Á; Department of Gastroenterology, Hospital Costa del Sol Marbella, Marbella, Spain.; Redes de Investigación Cooperativa Orientada a Resultados en Salud (RICORS), Marbella, Spain., Rodrigo L; Department of Gastroenterology, Hospital Universitario Central de Asturias, Oviedo, Spain., Pellicano R; Outpatient Clinic, Molinette-SGAS Hospital, University of Turin, Turin, Italy., Keco-Huerga A; Hospital Universitario Virgen de Valme, Sevilla, Spain., Pabón-Carrasco M; Hospital Universitario Virgen de Valme, Sevilla, Spain., Castro-Fernandez M; Hospital Universitario Virgen de Valme, Sevilla, Spain.; Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Sevilla, Spain., Boltin D; Department of Gastroenterology, Rabin Medical Center, Beilinson Campus, Tel Aviv University, Petach Tikva, Israel., Barrio J; Department of Gastroenterology, Hospital Rio Hortega, Valladolid, Spain., Phull P; Aberdeen Royal Infirmary, Aberdeen, UK., Kupcinskas J; Department of Gastroenterology, Lithuanian University of Health Sciences, Kaunas, Lithuania., Jonaitis L; Department of Gastroenterology, Lithuanian University of Health Sciences, Kaunas, Lithuania., Ortiz-Polo I; Department of Gastroenterology, Hospital Universitari i Politècnic La Fe, Valencia, Spain., Tepes B; Department of Gastroenterology, AM DC Rogaska, Rogaska Slatina, Slovenia., Lucendo AJ; Department of Gastroenterology, Hospital General de Tomelloso, Tomelloso, Spain., Huguet JM; Gastroenterology Unit, Consorcio Hospital General Universitario de Valencia, Valencia, Spain., Areia M; Francisco Gentil Portuguese Institute for Oncology of Coimbra, Coimbra, Portugal., Jurecic NB; Interni oddelek Diagnostic Centre, Bled, Slovenia., Denkovski M; Interni oddelek Diagnostic Centre, Bled, Slovenia., Bujanda L; Department of Gastroenterology, Hospital Universitario de Donostia, San Sebastian, Spain.; Instituto Biodonostia, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), San Sebastián, Spain., Ramos-San Román J; Department of Gastroenterology, Hospital Universitario de Donostia, San Sebastian, Spain., Cuadrado-Lavín A; Department of Gastroenterology and Hepatology, Hospital Universitario Marques de Valdecilla, Santander, Spain., Gomez-Camarero J; Gastroenterology, Hospital Universitario de Burgos, Burgos, Spain., Jiménez Moreno MA; Gastroenterology, Hospital Universitario de Burgos, Burgos, Spain., Lanas A; Department of Gastroenterology, Hospital Clínico Universitario Lozano Blesa, Zaragoza, Spain., Martinez-Dominguez SJ; Department of Gastroenterology, Hospital Clínico Universitario Lozano Blesa, Zaragoza, Spain., Alfaro E; Department of Gastroenterology, Hospital Clínico Universitario Lozano Blesa, Zaragoza, Spain., Marcos-Pinto R; Department of Gastroenterology, Centro Hospitalar do Porto, Porto, Portugal.; CINTESIS, University of Porto Institute of Biomedical Sciences Abel Salazar, Porto, Portugal., Milivojevic V; University Clinical Center of Serbia Clinic for Gastroenterology and Hepatology, Belgrade, Serbia.; School of Medicine, University of Belgrade, Belgrade, Serbia., Rokkas T; Department of Gastroenterology, Henry Dunant Hospital Center, Athens, Greece., Leja M; Digestive Disease Center GASTRO, Institute of Clinical and Preventive Medicine, Riga, Latvia.; University of Latvia Faculty of Medicine, Riga, Latvia., Smith S; Department of Clinical Medicine, Trinity College Dublin, Dublin, Ireland., Tonkić A; Department of Gastroenterology, University Hospital Center Split Križine, Split, Croatia., Buzás GM; Department of Gastroenterology, Ferencváros Health Centre, Budapest, Hungary., Doulberis M; Division of Gastroenterology and Hepatology, Kantonsspital Aarau AG, Aarau, Switzerland.; Department of Gastroenterology and Hepatology, University of Zurich, Zurich, Switzerland., Venerito M; Department of Gastroenterology, Hepatology and Infectious Diseases, Otto-von-Guericke University, Magdeburg, Germany., Lerang F; Department of Gastroenterololgy, Ostfold Hospital, Gralum, Norway., Bordin DS; Department of Pancreatic, Biliary and Upper Digestive Tract disorders, AS Loginov Moscow Clinical Scientific Center, Moscow, Russian Federation.; A.I. Yevdokimov Moscow State University of Medicine and Dentistry, Moscow, Russian Federation., Lamy V; CHU de Charleroi, Charleroi, Belgium., Capelle LG; Department of Gastroenterology and Hepatology, Erasmus University Medical Centre, Rotterdam, The Netherlands., Marlicz W; Department of Gastroenterology, Pomeranian Medical University, Szczecin, Poland., Dobru D; Department of Gastroenterology, University of Medicine, Pharmacy, Science, and Technology of Târgu Mures, Târgu Mures, Romania., Gridnyev O; National Academy of Medical Sciences of Ukraine, Kiiv, Ukraine., Puig I; Department of Digestive Diseases, Althaia, Xarxa Assistencial Universitària de Manresa, Manresa, Spain.; Universitat de Vic-Universitat Central de Catalunya (UVicUCC), Manresa, Spain., Mégraud F; INSERM U1312, Université de Bordeaux, Bordeaux, France., O'Morain C; Department of Gastroenterology, Trinity College Dublin, Dublin, Ireland., Gisbert JP; Gastroenterology Unit, Hospital Universitario de la Princesa, Madrid, Spain.; Instituto de Investigación Sanitaria Princesa (IIS-Princesa), Madrid, Spain.; Universidad Autónoma de Madrid (UAM), Madrid, Spain.; Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Madrid, Spain.
Jazyk: angličtina
Zdroj: Gut [Gut] 2022 Dec 05. Date of Electronic Publication: 2022 Dec 05.
DOI: 10.1136/gutjnl-2022-328232
Abstrakt: Objective: To evaluate the use, effectiveness and safety of Helicobacter pylori empirical rescue therapy in third and subsequent treatment lines in Europe.
Design: International, prospective, non-interventional registry of the clinical practice of European gastroenterologists. Data were collected and quality reviewed until October 2021 at Asociación Española de Gastroenterología-Research Electronic Data Capture. All cases with three or more empirical eradication attempts were assessed for effectiveness by modified intention-to-treat and per-protocol analysis.
Results: Overall, 2144 treatments were included: 1519, 439, 145 and 41 cases from third, fourth, fifth and sixth treatment lines, respectively. Sixty different therapies were used; the 15 most frequently prescribed encompassed >90% of cases. Overall effectiveness remained <90% in all therapies. Optimised treatments achieved a higher eradication rate than non-optimised (78% vs 67%, p<0.0001). From 2017 to 2021, only 44% of treatments other than 10-day single-capsule therapy used high proton-pump inhibitor doses and lasted ≥14 days. Quadruple therapy containing metronidazole, tetracycline and bismuth achieved optimal eradication rates only when prescribed as third-line treatment, either as 10-day single-capsule therapy (87%) or as 14-day traditional therapy with tetracycline hydrochloride (95%). Triple amoxicillin-levofloxacin therapy achieved 90% effectiveness in Eastern Europe only or when optimised. The overall incidence of adverse events was 31%.
Conclusion: Empirical rescue treatment in third and subsequent lines achieved suboptimal effectiveness in most European regions. Only quadruple bismuth-metronidazole-tetracycline (10-day single-capsule or 14-day traditional scheme) and triple amoxicillin-levofloxacin therapies reached acceptable outcomes in some settings. Compliance with empirical therapy optimisation principles is still poor 5 years after clinical practice guidelines update.
Trial Registration Number: NCT02328131.
Competing Interests: Competing interests: OPN has received research funding from Mayoly and Allergan. JPG has served as speaker, consultant and advisory member for or has received research funding from Mayoly, Allergan, Diasorin, Gebro Pharma and Richen. MC-F has received retribution from Allergan for formative actions. AP-A has received retribution from Allergan and Mylan for formative actions. Laimas Jonaitis has served as speaker for KRKA. AL has served as a consultant to Bayer.
(© Author(s) (or their employer(s)) 2022. No commercial re-use. See rights and permissions. Published by BMJ.)
Databáze: MEDLINE