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

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.