AUTHOR=Gravina Antonietta G. , Priadko Kateryna , Granata Lucia , Facchiano Angela , Scidà Giuseppe , Cerbone Rosa , Ciamarra Paola , Romano Marco 

TITLE=Single Capsule Bismuth Quadruple Therapy for Eradication of H. pylori Infection: A Real-Life Study

JOURNAL=Frontiers in Pharmacology

VOLUME=12

YEAR=2021

URL=https://www.frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2021.667584

DOI=10.3389/fphar.2021.667584

ISSN=1663-9812

ABSTRACT=<p><bold>Background and aim:</bold> Bismuth quadruple therapy (BQT) or non-bismuth quadruple therapy (i.e., concomitant therapy) (CT) is the first-line regimens to eradicate <italic>H. pylori</italic> infection in areas with high prevalence of clarithromycin (CLA) resistance. Guidelines suggest that in areas of high prevalence of <italic>H. pylori</italic> strains with double resistance (i.e., CLA + metronidazole), BQT should be preferred to CT. The aim of this study was to evaluate the efficacy and safety of BQT administered through the three-in-one pill (Pylera) formulation in a large series of <italic>H. pylori</italic>–infected patients, naive to treatment in a region with high CLA and dual resistance.</p><p><bold>Patients and methods:</bold> We treated 250 patients (148 F and 102 M, mean age 48.6 years) with H. <italic>pylori</italic> infection naïve to treatment. Patients received esomeprazole 40 mg bid and Pylera 3 tablets qid for 10 days. Diagnosis of H. <italic>pylori</italic> infection was through <sup>13</sup>C urea breath test (<sup>13</sup>C UBT), or stool antigen test or histology, as appropriate. The evaluation of eradication was through <sup>13</sup>C UBT at least 45 days after the end of therapy. Incidence of treatment-related adverse events (TRAEs) was assessed through a questionnaire at the end of treatment. Compliance was considered good if at least 90% of medication had been taken. Statistical analysis was per intention-to-treat e per protocol (PP). 95% confidence intervals (CIs) were calculated.</p><p><bold>Results:</bold> 1) 13 patients (5.2%) discontinued therapy due to side effects; 2) eradication rates in ITT and PP were 227/250 (90.8%; 95% CI 86.3–93.7%) and 226/237 (95.3%; 95% CI 91–99%), respectively; 3) the prevalence of TRAEs was 26.8%; and 4) adherence to treatment was good with compliance greater than 90%.</p><p><bold>Conclusion:</bold> In this real-life study, we demonstrate that in an area with a high prevalence of <italic>H. pylori</italic> strains with CLA or CLA + metronidazole resistance, BQT using Pylera is an effective therapeutic strategy with ITT eradication rates higher than 90%; this therapy is associated with good compliance and low incidence of side effects.</p>