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Empirical Second-Line Therapy in 5000 Patients of the European Registry on Helicobacter pylori Management (Hp-EuReg)
OP. Nyssen, D. Vaira, Á. Pérez Aísa, L. Rodrigo, M. Castro-Fernandez, L. Jonaitis, B. Tepes, L. Vologzhanina, M. Caldas, A. Lanas, AJ. Lucendo, L. Bujanda, J. Ortuño, J. Barrio, JM. Huguet, I. Voynovan, JP. Lasala, AS. Sarsenbaeva, L....
Jazyk angličtina Země Spojené státy americké
Typ dokumentu časopisecké články, multicentrická studie
- MeSH
- amoxicilin MeSH
- antibakteriální látky terapeutické užití MeSH
- bismut MeSH
- chinolony * terapeutické užití MeSH
- dospělí MeSH
- Helicobacter pylori * MeSH
- infekce vyvolané Helicobacter pylori * farmakoterapie MeSH
- inhibitory protonové pumpy MeSH
- klarithromycin terapeutické užití MeSH
- kombinovaná farmakoterapie MeSH
- levofloxacin MeSH
- lidé MeSH
- moxifloxacin terapeutické užití MeSH
- peniciliny škodlivé účinky MeSH
- prospektivní studie MeSH
- registrace MeSH
- tetracyklin terapeutické užití MeSH
- Check Tag
- dospělí MeSH
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
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.
Department of Gastroenterology A S Loginov Moscow Clinical Scientific Center Moscow Russia
Department of Gastroenterology Aberdeen Royal Infirmary Aberdeen United Kingdom
Department of Gastroenterology AM DC Rogaska Rogaska Slatina Slovenia
Department of Gastroenterology Centre Hospitalier Universitaire de Charleroi Charleroi Belgium
Department of Gastroenterology Chelyabinsk Regional Clinical Hospital Chelyabinsk Russia
Department of Gastroenterology Ferencváros Health Centre Budapest Hungary
Department of Gastroenterology Gastrocentr Perm Russia
Department of Gastroenterology Henry Dunant Hospital Athens Greece
Department of Gastroenterology HM Sanchinarro Madrid Spain
Department of Gastroenterology Hospital Clínico Universitario Valladolid Spain
Department of Gastroenterology Hospital de Asturias Oviedo Spain
Department of Gastroenterology Hospital de Valme Sevilla Spain
Department of Gastroenterology Hospital General de Tomelloso Tomelloso Spain
Department of Gastroenterology Hospital General Universitario de Valencia Valencia Spain
Department of Gastroenterology Hospital Río Hortega Valladolid Spain
Department of Gastroenterology Hospital San Pedro de Alcantara Cáceres Spain
Department of Gastroenterology Hospital Universitari i Politècnic La Fe Valencia Spain
Department of Gastroenterology Internal Medicine National Medical University Kyiv Ukraine
Department of Gastroenterology Interni Oddelek Diagnostic Centre Bled Slovenia
Department of Gastroenterology Meander Medical Center Amersfoort The Netherlands
Department of Gastroenterology Medical Microbiology Medical University of Sofia Sofia Bulgaria
Department of Gastroenterology Østfold Hospital Trust Grålum Norway
Department of Gastroenterology Otto von Guericke University Magdeburg Germany
Department of Gastroenterology Pomeranian Medical University Szczecin Poland
Department of Gastroenterology Portuguese Oncology Institute Coimbra Coimbra Portugal
Department of Gastroenterology Rabin Medical Center Tel Aviv University Petah Tikva Israel
Department of Gastroenterology Timisoara Hospital Timisoara Romania
Department of Surgical and Medical Sciences University of Bologna Bologna Italy
Faculty of Health Sciences Trinity College Dublin Dublin Ireland
Medical University Department Kantonsspital Aarau Aarau Switzerland
Citace poskytuje Crossref.org
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- $a Nyssen, Olga P $u 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
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- $a Empirical Second-Line Therapy in 5000 Patients of the European Registry on Helicobacter pylori Management (Hp-EuReg) / $c OP. Nyssen, D. Vaira, Á. Pérez Aísa, L. Rodrigo, M. Castro-Fernandez, L. Jonaitis, B. Tepes, L. Vologzhanina, M. Caldas, A. Lanas, AJ. Lucendo, L. Bujanda, J. Ortuño, J. Barrio, JM. Huguet, I. Voynovan, JP. Lasala, AS. Sarsenbaeva, L. Fernandez-Salazar, J. Molina-Infante, NB. Jurecic, M. Areia, A. Gasbarrini, J. Kupčinskas, D. Bordin, R. Marcos-Pinto, F. Lerang, M. Leja, GM. Buzas, Y. Niv, T. Rokkas, P. Phull, S. Smith, O. Shvets, M. Venerito, V. Milivojevic, I. Simsek, V. Lamy, P. Bytzer, L. Boyanova, L. Kunovský, C. Beglinger, M. Doulberis, W. Marlicz, A. Goldis, A. Tonkić, L. Capelle, I. Puig, F. Megraud, CO. Morain, JP. Gisbert, European Registry on Helicobacter pylori Management Hp-EuReg Investigators
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- $a 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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- $a Vaira, Dino $u Department of Surgical and Medical Sciences, University of Bologna, Bologna, Italy
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