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Limited effectiveness with a 10‐day bismuth‐containing quadruple therapy (Pylera ® ) in third‐line recue treatment for Helicobacter pylori infection. A real‐life multicenter study
Author(s) -
Rodríguez de Santiago Enrique,
Martín de Argila de Prados Carlos,
Marcos Prieto Hector Miguel,
Jorge Turrión Miguel Ãngel,
Barreiro Alonso Eva,
Flores de Miguel Alvaro,
Coba Ortiz Cristobal,
Rodríguez Escaja Carlos,
Pérez Álvarez Gustavo,
Ferre Aracil Carlos,
Aguilera Castro Lara,
García García de Paredes Ana,
Rodríguez Pérez Antonio,
Albillos Martínez Agustin
Publication year - 2017
Publication title -
helicobacter
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.206
H-Index - 79
eISSN - 1523-5378
pISSN - 1083-4389
DOI - 10.1111/hel.12423
Subject(s) - esomeprazole , medicine , amoxicillin , levofloxacin , clarithromycin , helicobacter pylori , regimen , pill , adverse effect , helicobacter pylori infection , intention to treat analysis , confidence interval , antibiotics , pharmacology , microbiology and biotechnology , biology
Background Helicobacter pylori antibiotic resistance is an increasing problem worldwide. Pylera ® may be an option as salvage therapy. Aim To assess the effectiveness, safety, and tolerance of Pylera ® as a third‐line in clinical practice. Materials and Methods This was a multicenter, observational, prospective database study in four Spanish hospitals. Consecutive H. pylori ‐infected individuals treated with Pylera ® and a proton‐pump inhibitor ( PPI ) were invited to participate if they had failed to respond to PPI ‐clarithromycin‐amoxicillin as first‐line and to levofloxacin‐amoxicillin‐ PPI as second‐line therapy. Eradication was tested 4‐8 weeks after Pylera ® using a C 13 ‐urea breath test. Treatment‐related adverse effects ( TRAE s) were assessed through a questionnaire and by reviewing databases. A questionnaire on patient satisfaction was completed in the last visit. Results Of 103 subjects fulfilling the selection criteria, 101 were included in the intention‐to‐treat ( ITT ) analysis and 97 in the per‐protocol ( PP ) analysis. A 10 day course was prescribed in all patients. Esomeprazole 40 mg b.i.d. was the most used PPI regimen ( ITT =94.1%). Ninety‐seven individuals ( ITT =96.04%) completed more than 90% of the treatment. Overall eradication rates were ITT =80.2% (95% confidence interval [ CI ]: 72.3%‐88.1%) and PP =84.4% (95% CI : 76.8%‐91.8%). One or more TRAE s were experienced by 67.3% (95% CI : 57.7%‐75.7%), all mild or moderate. TRAE s and the number of pills were the main complaints. Conclusion In an area of high antibiotic resistance to H. pylori , 10‐day Pylera ® plus double‐dose PPI emerged as an alternative as third‐line therapy, although not achieving optimal eradication rates. TRAE s were common but were neither severe nor did they condition compliance.