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

Abstract 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.