title: New bismuth-containing quadruple therapy in patients infected with Helicobacter pylori: A first Italian experience in clinical practice.
abstract: BACKGROUND
  Rising antibiotic resistance requires the evaluation of new and effective therapies.
  
  
  OBJECTIVE
  To test the efficacy and safety of the new bismuth-containing quadruple therapy in patients infected with Helicobacter pylori.
  
  
  METHODS
  Consecutive H. pylori-positive dyspeptic patients were enrolled, either naïve or with previous failure treatment. Patients were treated with Pylera®(three-in-one capsules containing bismuth subcitrate potassium 140 mg, metronidazole 125 mg, and tetracycline 125 mg) three capsules q.i.d. plus omeprazole 20 mg or esomeprazole 40 mg b.i.d. for 10 days. Eradication was confirmed using an urea breath test (at least 30 days after the end of treatment). Efficacy was assessed by UBT and safety by means of treatment-emergent adverse events.
  
  
  RESULTS
  One hundred and thirty-one patients were included in the study: 42% of patients were naïve, and 58%, with previous failure treatment. H. pylori eradication was achieved in 124 patients (94.7%, 95% confidence intervals (CIs) 89.3-97.8) in ITT population. In the PP population, the percentage was 97.6% (95%, CIs 93.3-99.2). No difference in eradication rate was found either between naïve and previously treated patients (92.7% vs 96.0%, P=.383), or smoking and nonsmoking ones, or in patients taking omeprazole or esomeprazole. Treatment-emergent adverse events occurred in 35 patients (26.7%, 95% CIs 19.9-34.9). They were mild in all cases except in four, who discontinued the study due to diarrhea (three patients) and diffuse urticarial rush (one patient).
  
  
  CONCLUSIONS
  Pylera®achieved a remarkable eradication rate in clinical practice, irrespective if it was used as first treatment or as a rescue therapy. Treatment-emergent adverse events were uncommon generally mild.
authors.affiliation: Gastroenterology Service, ASL BAT, Andria (BT), Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Tursi
authors.affiliation: Department of Clinical & Experimental Medicine, Gastroenterology Unit, University of Parma, Parma, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Di Mario
authors.affiliation: Digestive Endoscopy Unit, ULSS4 Alto Vicentino, Santorso, Schio (VI), Italy.
authors.forename: Marilisa
authors.initials: M
authors.lastname: Franceschi
authors.affiliation: Italian Association for Gastroenterology in Primary Care (GICA-CP), Feltre (BL), Italy.
authors.forename: Rudi
authors.initials: R
authors.lastname: De Bastiani
authors.affiliation: Division of Gastroenterology, ASL RM6, Albano Laziale (Roma), Italy.
authors.forename: Walter
authors.initials: W
authors.lastname: Elisei
authors.affiliation: Digestive Endoscopy Unit, ULSS4 Alto Vicentino, Santorso, Schio (VI), Italy.
authors.forename: Gianluca
authors.initials: G
authors.lastname: Baldassarre
authors.affiliation: Digestive Endoscopy Unit, ULSS4 Alto Vicentino, Santorso, Schio (VI), Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Ferronato
authors.affiliation: Department of Clinical & Experimental Medicine, Gastroenterology Unit, University of Parma, Parma, Italy.
authors.forename: Simone
authors.initials: S
authors.lastname: Grillo
authors.affiliation: Department of Clinical & Experimental Medicine, Gastroenterology Unit, University of Parma, Parma, Italy.
authors.forename: Stefano
authors.initials: S
authors.lastname: Landi
authors.affiliation: Italian Association for Gastroenterology in Primary Care (GICA-CP), Feltre (BL), Italy.
authors.forename: Maria
authors.initials: M
authors.lastname: Zamparella
authors.affiliation: Italian Association for Gastroenterology in Primary Care (GICA-CP), Feltre (BL), Italy.
authors.forename: Manuela
authors.initials: M
authors.lastname: De Polo
authors.affiliation: Italian Association for Gastroenterology in Primary Care (GICA-CP), Feltre (BL), Italy.
authors.forename: Laura
authors.initials: L
authors.lastname: Boscariolo
authors.affiliation: Division of Surgery, "P. Colombo" Hospital, ASL RM6, Velletri (Rome), Italy.
authors.forename: Marcello
authors.initials: M
authors.lastname: Picchio
mesh_terms: D000900:Anti-Bacterial Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001729:Bismuth / Q000009:adverse effects / Q000627:therapeutic use*; D001944:Breath Tests; D004359:Drug Therapy, Combination / Q000009:adverse effects / Q000379:methods; D005260:Female; D016481:Helicobacter Infections / Q000188:drug therapy*; D016480:Helicobacter pylori / Q000302:isolation & purification*; D006801:Humans; D007558:Italy; D008297:Male; D008795:Metronidazole / Q000009:adverse effects / Q000627:therapeutic use; D008875:Middle Aged; D011446:Prospective Studies; D054328:Proton Pump Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D013752:Tetracycline / Q000009:adverse effects / Q000627:therapeutic use; D016896:Treatment Outcome; D014508:Urea / Q000032:analysis
chemical_list: D000900:Anti-Bacterial Agents; D054328:Proton Pump Inhibitors; D008795:Metronidazole; D014508:Urea; D013752:Tetracycline; D001729:Bismuth
keywords: 
  Helicobacter pylori
  ; antibiotics; bismuth-containing therapy; treatment