Tegoprazan dual and quadruple therapy for eradication: a prospective, randomized controlled trial in Beijing, China.

OBJECTIVE

The identification of novel and effective treatments for () infection remains a critical need. Treatment is indicated for peptic ulcer disease, gastric MALT lymphoma, and gastric cancer prevention, following diagnosis via non-invasive testing or endoscopy. This study aimed to investigate the efficacy and safety of tegoprazan-based regimens compared to bismuth-containing quadruple therapy in eradication.

PATIENTS AND METHODS

In a randomized, controlled, treatment-naïve adult patients with confirmed infection were assigned in a 1:1:1 ratio to one of the following 14-day open-label therapies: BQT (rabeprazole 10 mg twice daily, compound bismuth aluminate granules 2.6 g thrice daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily), tegoprazan-based therapies (TAD, tegoprazan 50 mg twice daily, amoxicillin 1 g thrice daily; TBQT, tegoprazan 50 mg twice daily, compound bismuth aluminate granules 2.6 g thrice daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily). The primary outcome was the eradication rate of . Secondary outcomes included the assessment of adverse events and treatment compliance.

RESULTS

A total of 468 patients were enrolled. The eradication rates for TBQT, TAD and BQT were 86.3, 85.5 and 77.2%, respectively, by intention-to-treat analysis ( = 0.059), and 87.3, 87.2 and 77.7%, respectively, by per-protocol analysis ( = 0.029). The incidence of adverse events was comparable between the BQT and tegoprazan-based therapies ( > 0.05). Treatment compliance was similar across all three groups.

CONCLUSION

Tegoprazan-based therapies achieved acceptable eradication rates exceeding 85%, outperforming the BQT. Additionally, tegoprazan-amoxicillin dual therapy may serve as an alternative eradication regimen in regions with high clarithromycin resistance.

CLINICAL TRIAL REGISTRATION

http://clinicaltrials.gov, Identifier ChiCTR2300077088.