First-Line Therapy for Helicobacter pylori in Slovenia: Data From 2013 to 2023 of the European Registry on H. pylori Management.

Background: Treatment is indicated for all Helicobacter pylori infections. However, the best approach for H. pylori management remains unclear.

Methods: H. pylori eradication data from Hp-EuReg on treatment-naive patients in Slovenia from 2013 to 2023 were included. The regimens prescribed, the number of eradication attempts, effectiveness, adherence, and safety were analyzed. The effectiveness was assessed by modified intention to treat (mITT).

Results: Eight Slovenian medical institutions contributed data for 4016 treatment-naive patients to Hp-EuReg. Of these, 18% did not undergo confirmatory post-treatment; most who did received a urea breath test. Between 2013 and 2018, 7-day triple therapy with amoxicillin and clarithromycin was most frequently used in first-line treatment, with an 88% eradication rate. From 2019 to 2023, a 14-day high-dose PPI (esomeprazole 40 mg b.i.d.) triple therapy with amoxicillin and clarithromycin was used, showing a significantly higher effectiveness at 94% (p < 0.05). Quadruple bismuth-based therapy (esomeprazole 40 mg b.i.d., plus amoxicillin 500 mg, metronidazole 400 mg, and bismuth 120 mg, all q.i.d.) provided a 96.9% eradication rate, though this was not significantly better than the 14-day triple regimen. The H. pylori resistance rate to clarithromycin was 16% from 2013 to 2018, dropping to 13.5% from 2019 to 2023. Side effects were reported by 9.6% of patients, and treatment compliance was > 99%.

Conclusions: The study suggests that systematic data collection from routine clinical practice in Hp-EuReg can guide first-line H. pylori treatment. Established 90% treatment effectiveness threshold may serve as a surrogate marker for monitoring H. pylori resistance rates to antibiotics. In countries with a H. pylori resistance rate < 15%, such as Slovenia, the 14-day high-dose PPI amoxicillin-clarithromycin regimen is an optimal first-line empirical treatment.

Trial Registration: NCT02328131.