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Bismuth-based Quadruple Therapy Following H. pylori Eradication Failures: a Multicenter Study in Clinical Practice

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Angelo Zullo1, Vincenzo De Francesco2, Annamaria Bellesia2, Roberto Vassallo3, Audenzio D’Angelo4, Giuseppe Scaccianoce4, Rodolfo Sacco5, Giampaolo Bresci5, Annarita Eramo6, Anna Tanzilli6, Lorenzo Ridola7, Domenico Alvaro7, Claudio Londoni8, Gianfranco Brambilla8, Raffaele Manta9, Agostino Di Ciaula10, Piero Portincasa10
1) Gastroenterology, Nuovo Regina Margherita Hospital, Rome;
2) Gastroenterology, Riuniti Hospital, Foggia;
3) Gastroenterology, Buccheri La Ferla Fatebenefratelli Hospital, Palermo;
4) Gastroenterology, Fabio Perinei Hospital, Altamura;
5) Gastroenterology, Azienda Ospedalerio-Univeristaria Pisana, Pisa;
6) Gastroenterology, Santa Scolastica Hospital, Cassino;
7) Dept. of Medico-Surgical Sciences and Biotechnologies, Sapienza University of Rome, Latina;
8) Gastroenterology, Maggiore Hospital, Crema;
9) Gastroenterology, Nuovo Ospedale Civile Sant‘Agostino-Estense, Baggiovara-Modena;
10) Dept. of Biomedical Sciences and Human Oncology, University of Bari, Bari, Italy

DOI: http://dx.doi.org/10.15403/jgld.2014.1121.263.zul

Background & Aims: Helicobacter pylori (H. pylori) eradication in patients who failed one or more therapeutic attempts remains challenging. This study aimed to assess the efficacy of three-in-one capsules bismuth-based quadruple therapy (Pylera®) in these patients managed in clinical practice.

Methods: This was a prospective, open-label, multicenter study enrolling consecutive, adult patients with persistent H. pylori infection following at least one standard therapy. All patients received a rescue quadruple therapy with Pylera (3 capsules four times daily) and esomeprazole 20 mg (1 tablet twice daily) for 10 days. H. pylori eradication was assessed by using Urea Breath Test 4-6 weeks following therapy ending. H. pylori eradication rates, compliance, and side-effects were calculated.

Results: A total of 208 patients in the 9 participating centres were enrolled. Overall, 180 patients were successfully cured from the infection, accounting for 86.5% (95% CI 81.9-91.2) and 92.3% (95% CI 88.6-96.1) eradication rates at intention-to-treat analysis and at per protocol analysis, respectively. Cure rates were similar across patients who failed one to three previous therapy attempts, but the success rate fell to 67% after 4 or more therapy failures. Compliance to therapy was good in 198 (95.2%) patients, whilst in 7 (5.3%) cases the therapy was interrupted within 5 days due to side effects. A total of 97 (46.6%) patients complained of at least one side effect; nausea, diarrhea and vomiting were the most frequently reported.

Conclusions: Our study found that this bismuth-based quadruple therapy is highly effective as second-line and rescue therapy for H. pylori eradication in clinical practice.

Key words: Helicobacter pylori – quadruple therapy – rescue therapy – bismuth.

Abbreviations: CI: confidence intervals; ITT: intention-to-treat; PP: per protocol; UBT: urea breath test.