Is Pylera® Still Effective and Safe in Patients Infected by Helicobacter pylori? A 6-Year, Multicentre, Real-Life Study

INTRODUCTION: More than 10 years after its introduction into clinical practice, we aimed to assess the current real-life effectiveness and safety of bismuth-containing quadruple therapy in patients infected with Helicobacter pylori. METHODS: Consecutive dyspeptic H pylori-positive patients were enrolled, both naïve for treatment and already unsuccessfully treated. Patients received Pylera® 3 capsules 4 times daily plus omeprazole 20 mg or esomeprazole 40 mg b.i.d. for 10 days. Eradication was confirmed using a urea breath test (at least 30 days after the end of treatment). We assessed the effectiveness and safety of Pylera® in these patients. RESULTS: A total of 1,018 consecutive patients were included in the study, 648 (63.7%) treated as first-line and 370 (36.3%) treated after failure of at least 1 previous eradication course. The vast majority of patients were fully compliant, except 18 (1.8%) subjects, who discontinued treatment due to severe adverse events. Helicobacter pylori eradication was achieved in 959/1,000 (95.9%, CI 94.7%-97.1%) patients, higher in naïve than in previously treated patients (97.3%, CI 96.1%-98.6%, vs. 93.3%, CI 90.8%-95.9%; p = 0.002). Overall, the eradication rate remains significantly high during the observational period. In particular, it was 100% in 2020, 97.8% (CI 95.7%-99.9%) in 2021, 100% in 2022, 98.8% (CI 97.3%-100%) in 2023, 89.1% (CI 84.6%-93.6%) in 2024, and 97.8% (CI 95.5%-100%) in 2025: the failures, although minimal, were more present in 2024 (p < 0.001). Finally, the eradication rate remained constant from 2020 to 2025. CONCLUSIONS: Pylera® remains an effective and safe therapeutic option for curing H pylori infection in both naïve and previously treated patients.