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 practic
