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Empirical Second-Line Therapy in 5000 Patients of the European Registry on Helicobacter pylori Management (Hp-EuReg).
Nyssen, Olga P; Vaira, Dino; Pérez Aísa, Ángeles; Rodrigo, Luis; Castro-Fernandez, Manuel; Jonaitis, Laimas; Tepes, Bojan; Vologzhanina, Liudmila; Caldas, María; Lanas, Angel; Lucendo, Alfredo J; Bujanda, Luis; Ortuño, Juan; Barrio, Jesús; Huguet, Jose M; Voynovan, Irina; Lasala, Jorge Perez; Sarsenbaeva, Aiman Silkanovna; Fernandez-Salazar, Luis; Molina-Infante, Javier; Jurecic, Natasa Brglez; Areia, Miguel; Gasbarrini, Antonio; Kupcinskas, Juozas; Bordin, Dmitry; Marcos-Pinto, Ricardo; Lerang, Frode; Leja, Marcis; Buzas, Gyorgy M; Niv, Yaron; Rokkas, Theodore; Phull, Perminder; Smith, Sinead; Shvets, Oleg; Venerito, Marino; Milivojevic, Vladimir; Simsek, Ilkay; Lamy, Vincent; Bytzer, Peter; Boyanova, Lyudmila; Kunovský, Lumír; Beglinger, Christoph; Doulberis, Michael; Marlicz, Wojciech; Goldis, Adrian; Tonkic, Ante; Capelle, Lisette; Puig, Ignasi; Megraud, Francis; Morain, Colm O'.
Affiliation
  • Nyssen OP; Department of Gastroenterology, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa, Universidad Autónoma de Madrid, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, Madrid, Spain.
  • Vaira D; Department of Surgical and Medical Sciences, University of Bologna, Bologna, Italy.
  • Pérez Aísa Á; Department of Gastroenterology, Agencia Sanitaria Costa del Sol, Red de Investigación en Servicios de Salud en Enfermedades Crónicas, Marbella, Spain.
  • Rodrigo L; Department of Gastroenterology, Hospital de Asturias, Oviedo, Spain.
  • Castro-Fernandez M; Department of Gastroenterology, Hospital de Valme, Sevilla, Spain.
  • Jonaitis L; Department of Gastroenterology, Institute for Digestive Research, Lithuanian University of Health Sciences, Kaunas, Lithuania.
  • Tepes B; Department of Gastroenterology, AM DC Rogaska, Rogaska Slatina, Slovenia.
  • Vologzhanina L; Department of Gastroenterology, Gastrocentr, Perm, Russia.
  • Caldas M; Department of Gastroenterology, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa, Universidad Autónoma de Madrid, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, Madrid, Spain.
  • Lanas A; Department of Gastroenterology, Hospital Clínico Universitario/Instituto de Investigacion Sanitaria Aragón, University of Zaragoza, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, Zaragoza, Spain.
  • Lucendo AJ; Department of Gastroenterology, Hospital General de Tomelloso, Tomelloso, Spain.
  • Bujanda L; 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.
  • Ortuño J; Department of Gastroenterology, Hospital Universitari i Politècnic, La Fe, Valencia, Spain.
  • Barrio J; Department of Gastroenterology, Hospital Río Hortega, Valladolid, Spain.
  • Huguet JM; Department of Gastroenterology, Hospital General Universitario de Valencia, Valencia, Spain.
  • Voynovan I; Department of Gastroenterology, A.S. Loginov Moscow Clinical Scientific Center, Moscow, Russia.
  • Lasala JP; Department of Gastroenterology, HM Sanchinarro, Madrid, Spain.
  • Sarsenbaeva AS; Department of Gastroenterology, Chelyabinsk Regional Clinical Hospital, Chelyabinsk, Russia.
  • Fernandez-Salazar L; Department of Gastroenterology, Hospital Clínico Universitario, Valladolid, Spain.
  • Molina-Infante J; Department of Gastroenterology, Hospital San Pedro de Alcantara, Cáceres, Spain.
  • Jurecic NB; Department of Gastroenterology, Interni Oddelek, Diagnostic Centre, Bled, Slovenia.
  • Areia M; Department of Gastroenterology, Portuguese Oncology Institute Coimbra, Coimbra, Portugal.
  • Gasbarrini A; Medicina Interna, Fondazione Policlinico Universitario A. Gemelli Istituto di Ricovero e Cura a Carattere Scientifico, Università Cattolica del Sacro Cuore, Roma, Italy.
  • Kupcinskas J; Department of Gastroenterology, Institute for Digestive Research, Lithuanian University of Health Sciences, Kaunas, Lithuania.
  • Bordin D; Department of Gastroenterology, A.S. Loginov Moscow Clinical Scientific Center, Moscow, A.I. Yevdokimov Moscow State University of Medicine and Dentistry, Moscow, Tver State Medical University, Tver, Russia.
  • Marcos-Pinto R; Department of Gastroenterology, Centro Hospitalar do Porto Institute of Biomedical Sciences Abel Salazar, Centro de Investigação em Tecnologias e Serviços de Saúde, University of Porto, Porto, Portugal.
  • Lerang F; Department of Gastroenterology, Østfold Hospital Trust, Grålum, Norway.
  • Leja M; Department of Gastroenterology, Digestive Diseases Centre Gastro, Institute of Clinical and Preventive Medicine and Faculty of Medicine, University of Latvia, Riga, Latvia.
  • Buzas GM; Department of Gastroenterology, Ferencváros Health Centre, Budapest, Hungary.
  • Niv Y; Department of Gastroenterology, Rabin Medical Center, Tel Aviv University, Petah Tikva, Israel.
  • Rokkas T; Department of Gastroenterology, Henry Dunant Hospital, Athens, Greece.
  • Phull P; Department of Gastroenterology, Aberdeen Royal Infirmary, Aberdeen, United Kingdom.
  • Smith S; Faculty of Health Sciences, Trinity College Dublin, Dublin, Ireland.
  • Shvets O; Department of Gastroenterology, Internal Medicine, National Medical University, Kyiv, Ukraine.
  • Venerito M; Department of Gastroenterology, Otto-von-Guericke University, Magdeburg, Germany.
  • Milivojevic V; Department of Gastroenterology, Clinical Center of Serbia, University of Belgrade School of Medicine, Belgrade, Serbia.
  • Simsek I; Department of Gastroenterology, Internal Medicine, Hacettepe, University School of Medicine, Ankara, Turkey.
  • Lamy V; Department of Gastroenterology, Centre Hospitalier Universitaire de Charleroi, Charleroi, Belgium.
  • Bytzer P; Department of Gastroenterology, Clinical Medicine, Zealand University Hospital, Copenhagen University, Copenhagen, Denmark.
  • Boyanova L; Department of Gastroenterology, Medical Microbiology, Medical University of Sofia, Sofia, Bulgaria.
  • Kunovský L; Department of Gastroenterology and Internal Medicine, Department of Surgery, University Hospital Brno, Faculty of Medicine, Masaryk University, Brno, Czech Republic.
  • Beglinger C; Medical University Department, Kantonsspital Aarau, Aarau, Switzerland.
  • Doulberis M; Emergency Department, University Hospital Inselspital of Bern, Bern, Switzerland, Second Medical Clinic, School of Medicine, Aristotle University of Thessaloniki, Ippokration Hospital, Thessaloniki, Macedonia, Greece, and First Laboratory of Pharmacology, Aristotle University of Thessaloniki, Thessa
  • Marlicz W; Department of Gastroenterology, Pomeranian Medical University, Szczecin, Poland.
  • Goldis A; Department of Gastroenterology, Timisoara Hospital, Timisoara, Romania.
  • Tonkic A; Department of Gastroenterology, University Hospital of Split, University of Split School of Medicine, Split, Croatia.
  • Capelle L; Department of Gastroenterology, Meander Medical Center, Amersfoort, The Netherlands.
  • Puig I; Department of Gastroenterology, Althaia Xarxa Assistencial Universitària de Manresa, Universitat de Vic-Universitat Central de Catalunya, Manresa, Spain.
  • Megraud F; Institut national de la santé et de la recherche médicale (INSERM) U1312 BRIC Team 4, University of Bordeaux, Bordeaux, France.
  • Morain CO; Faculty of Health Sciences, Trinity College Dublin, Dublin, Ireland.
Clin Gastroenterol Hepatol ; 20(10): 2243-2257, 2022 10.
Article in En | MEDLINE | ID: mdl-34954341
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. ClincialTrials.gov number: NCT02328131.
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Helicobacter pylori / Helicobacter Infections / Quinolones Type of study: Clinical_trials / Guideline / Observational_studies Limits: Adult / Humans Language: En Journal: Clin Gastroenterol Hepatol Journal subject: GASTROENTEROLOGIA Year: 2022 Document type: Article Affiliation country: Country of publication:

Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Helicobacter pylori / Helicobacter Infections / Quinolones Type of study: Clinical_trials / Guideline / Observational_studies Limits: Adult / Humans Language: En Journal: Clin Gastroenterol Hepatol Journal subject: GASTROENTEROLOGIA Year: 2022 Document type: Article Affiliation country: Country of publication: