Effectiveness of First-Line Empirical Treatment in Portugal: Data from the European Registry on Helicobacter pylori Management

Abstract

Abstract – Introduction: As Portugal exhibits some of the highest gastric cancer rates in Europe, optimizing the Helicobacter pylori eradication rate is imperative. We aimed to describe H. pylori treatment regimens in Portugal, within a real clinical practice setting. Methods: This is a prospective cohort study of the Portuguese patients diagnosed with H. pylori between May 2013 and December 2022, within the European Registry on Helicobacter pylori Management (Hp-EuReg). The demographic and clinical data, diagnostic methods, treatment regimens, and prescription trends with their effectiveness were analysed by modified intention-to-treat (mITT) and per-protocol (PP) analyses. Results: Overall, 700 cases, mainly from 2 centres (98% of cases), were included, with 59% females, with a mean age of 54 ± 15 years. Treatment-naïve patients encompassed 81% of cases. Overall compliance (>90% drug intake) was reported in 99% of cases. Overall effectiveness was 87%, by both mITT and PP analyses. The triple PPI-clarithromycin-amoxicillin therapy decreased from 29% in 2013 to 0% in 2022. Conversely, both quadruple concomitant PPI-clarithromycin-amoxicillin-metronidazole and PPI-bismuth-metronidazole-tetracycline therapies were predominantly used from 2016 onwards, with PPI-bismuth-metronidazole-tetracycline representing 76% of all prescriptions in 2022, achieving an overall mITT effectiveness of 92% and 91%, respectively. Conclusion: In Portugal, concomitant quadruple therapy with PPI-clarithromycin-amoxicillin-metronidazole and bismuth quadruple with PPI-bismuth-metronidazole-tetracycline provided both optimal (>90%) effectiveness, in line with results of other Southern European countries.