Efficacy of tegoprazan-based bismuth quadruple therapy compared with bismuth quadruple therapy for Helicobacter pylori infection: A randomized, double-blind, active-controlled study.

Background: Bismuth-based quadruple therapy (BQT) is recommended as the first-line empirical therapy for Helicobacter pylori eradication as it is not associated with resistance. However, few studies have investigated the use of potassium-competitive acid blockers for BQT.

Aim: To investigate the efficacy and safety profiles of tegoprazan-based BQT (TBMT) versus lansoprazole-based BQT (LBMT) for H. pylori eradication.

Methods: We included patients older than 18 with an H. pylori infection without a history of H. pylori eradication who visited four university-affiliated hospitals between March 2020 and December 2021. H. pylori infection was diagnosed using a rapid urease test or Giemsa staining. Patients were randomly assigned to the TBMT or LBMT group.

Results: 217 subjects were randomly allocated to receive either TBMT (n = 108) or LBMT (n = 109) therapy. Intention-to-treat (ITT) eradication rates of TBMT and LBMT were 80.0% and 77.4% (95% confidence interval [CI]: -8.4 to 13.7, p = 0.0124), respectively. Corresponding modified ITT rates were 90.3% and 84.5% (95% CI: -3.6 to 15.2, p = 0.0005), respectively. Per-protocol (PP) eradication rates of TBMT and LBMT were 90.2% and 82.4% (95% CI: -2.5 to 18.2, p = 0.0003), respectively. There was no significant difference in the rate of adverse events between the TBMT and LBMT groups (39.1% vs. 43.4%, p = 0.5211). TBMT showed higher eradication rates than that of LBMT in ITT, m-ITT, and PP analysis.

Conclusion: TBMT showed a noninferior eradication rate and similar adverse events to LBMT as a first-line eradication regimen. Our results suggest that tegoprazan might be substituted for proton pump inhibitors in H. pylori eradication regimens.