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A 14-day tegoprazan–amoxicillin dual therapy achieves over 90% H. pylori eradication and is noninferior to bismuth-based quadruple therapy, while the 10-day regimen shows inadequate efficacy.
A new multicenter randomized controlled trial highlights the growing role of tegoprazan-based therapy in the management of Helicobacter pylori (H. pylori) infection, demonstrating that a 14-day tegoprazan–amoxicillin dual regimen is as effective and safe as the current standard bismuth-containing quadruple therapy.
H. pylori infection remains key driver of gastric cancer, chronic gastritis, and peptic ulcer disease. Tegoprazan, a potassium-competitive acid blocker (P-CAB), yields rapid and sustained acid inhibition, which may enhance antibiotic effectiveness. This study evaluated whether Tegoprazan plus amoxicillin dual therapy could provide eradication rates noninferior to the current bismuth-based standard regimen. Overall, 228 patients with confirmed H. pylori infection were randomly assigned to one of three treatment arms:
Eradication outcomes were assessed using per-protocol (PP), modified intention-to-treat (MITT), and intention-to-treat (ITT) analyses. Safety, adverse events, and compliance were also evaluated.
The 14-TA group exhibited no statistically significant difference in H. pylori elimination rates compared with the bismuth quadruple group across PP, MITT, and ITT analyses (p > 0.05). Noninferiority of the 14-TA was confirmed in the PP analysis (p = 0.0488). The 10-TA regimen showed markedly lower H. pylori elimination rates when compared with bismuth quadruple therapy across all analytical populations (p < 0.05), as shown in Table 1:
Adverse event rates were comparable among all three treatment groups. Treatment compliance did not differ significantly between regimens. No novel or unexpected safety risks were reported with Tegoprazan-based therapy. To sum up, 14-day tegoprazan-based dual therapy is noninferior to bismuth quadruple therapy for H. pylori eradication, with a favorable compliance and safety profile. However, shortening the regimen to 10 days results in unacceptable eradication rates and should not be advocated.
Journal of Gastroenterology and Hepatology
Fourteen-and Ten-Day Tegoprazan-Amoxicillin Dual Therapy vs. Bismuth Quadruple Therapy for Helicobacter pylori Eradication-A Noninferiority, Multicenter, Randomized Controlled Trial
Yan Fan et al.
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