IS PYLERA® STILL EFFECTIVE AND SAFE IN PATIENTS INFECTED BY HELICOBACTER PYLORI? A SIX-YEARS, MULTICENTRE, REAL LIFE STUDY.

INTRODUCTION

More than ten 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 H. pylori.

METHODS

Consecutive dyspeptic H. pylori-positive patients were enrolled, both naïve for treatment and already unsuccessfully treated. Patients received Pylera® 3 capsules four times daily plus omeprazole 20 mg or esomeprazole 40 mg bid for 10 days. Eradication was confirmed using a urea-breath test (at least 30 days after the end of treatment). We assessed effectiveness and safety in these patients.

RESULTS

One thousand and eighteen consecutive patients were included in the study, 648 (63.7%) treated as first-line and 370 (36.3%) treated after failure of at least one previous eradication course. The vast majority of patients were fully compliant, except 18 (1.8%) subjects, who discontinued treatment due to severe adverse events. H. 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.