Efficacy and Safety of Tegoprazan-Based Dual, Triple, and Quadruple Therapies in First-Line Helicobacter Pylori Eradication: A Prospective Randomized Controlled Trial.

BACKGROUND:Resistance to antibiotics has resulted in the effectiveness of conventional eradication therapies for Helicobacter pylori being reduced, creating a need for regimens that are effective, safe, and simple. In this study, we evaluated the eradication efficacy, adverse events, and medication adherence of four different tegoprazan-based regimens administered as first-line therapy for H. pylori infection. We also explored the clinical value of adding bismuth to a triple therapy regimen. METHODS:In this prospective, randomized controlled trial, 640 treatment-naive patients with confirmed H. pylori infection were randomly assigned to one of the four groups undergoing 14-day treatment regimens of tegoprazan-amoxicillin (TA), tegoprazan-tetracycline (TT), tegoprazan-amoxicillin-tetracycline (TAT), or tegoprazan-amoxicillin-tetracycline-bismuth (TATB), with 160 patients in each group. The outcomes were the eradication rate, incidence of adverse events, and medication adherence. RESULTS:In the intention-to-treat analysis, the H. pylori eradication rates in the TA, TT, TAT, and TATB groups were 80.0% (95% confidence interval [CI]: 73.0-85.9), 61.9% (95% CI: 53.9-69.4), 93.1% (95% CI: 88.0-96.5), and 89.4% (95% CI: 83.5-93.7), respectively. Compared with the TATB regimen, the TAT regimen was non-inferior (95% CI, -3.9% to 11.5%; non-inferiority p < 0.001), whereas demonstrating non-inferiority in the TA and TT regimens failed. Adverse events were less frequent in the TA (10.6%), TT (17.5%), and TAT (20.0%) groups than in the TATB group (36.9%; all p < 0.001). Medication adherence was high across groups, with no significant between-group differences observed. CONCLUSIONS:High eradication efficacy was demonstrated for the TAT regimen; this regimen was non-inferior to the TATB regimen, and it was associated with fewer adverse events. These findings suggest that it may be an effective first-line treatment option for H. pylori infection. TRIAL REGISTRATION:ClinicalTrials.gov identifier: NCT06977841.