Efficacy of Tegoprazan‐Containing Sequential Eradication Treatment Compared to Esomeprazole‐Containing Sequential Eradication of Helicobacter pylori in South Korea, a Region With High Antimicrobial Resistance: A Prospective, Randomized, Single Tertiary Center Study

• Published in: Helicobacter (Cambridge, Mass.) Vol. 29; no. 5; pp. e13143 - n/a
• Main Authors: Lee, Jung Won, Kim, Nayoung, Lee, Jongchan, Jo, So Young, Lee, Dong Ho
• Format: Journal Article
• Language: English
• Published: England Wiley Subscription Services, Inc 01-09-2024
• Subjects: Acid resistance; Adult; Aged; Amoxicillin; Amoxicillin - administration & dosage; Amoxicillin - therapeutic use; Anti-Bacterial Agents - administration & dosage; Anti-Bacterial Agents - therapeutic use; Antimicrobial agents; Antimicrobial resistance; Bismuth; Clarithromycin; Clarithromycin - administration & dosage; Clarithromycin - therapeutic use; Competitive materials; Drug resistance; Drug Resistance, Bacterial; Drug Therapy, Combination; Effectiveness; Eradication; esomeprazole; Esomeprazole - administration & dosage; Esomeprazole - therapeutic use; Female; Helicobacter Infections - drug therapy; Helicobacter pylori; Helicobacter pylori - drug effects; Humans; Male; Metronidazole; Metronidazole - administration & dosage; Metronidazole - therapeutic use; Middle Aged; Omeprazole; Potassium; Prospective Studies; Proton Pump Inhibitors - administration & dosage; Proton Pump Inhibitors - therapeutic use; Pyrroles; Republic of Korea; sequential therapy; Statistical analysis; Sulfonamides; tegoprazan; Tertiary Care Centers; Therapy; Treatment Outcome; Republic of Korea; South Korea; sequential therapy; esomeprazole; Helicobacter pylori; eradication; tegoprazan
• ISSN: 1083-4389; 1523-5378; 1523-5378
• DOI: 10.1111/hel.13143

ABSTRACT
Background
Treatment with potassium‐competitive acid blockers has shown acceptable efficacy in Helicobacter pylori eradication. In regions like Korea, where the clarithromycin resistance rate is high, alternative combinations like non‐bismuth quadruple therapies have shown favorable results. This study compared the outcomes of sequential eradication therapy with new potassium‐competitive acid blocker tegoprazan and conventional esomeprazole‐containing sequential therapy.
Materials and Methods
Patients with Helicobacter pylori (H. pylori) infection were consecutively recruited. Patients were allocated to either an esomeprazole‐containing sequential or a tegoprazan‐containing sequential therapy group. Sequential therapy comprised esomeprazole (40 mg) or tegoprazan (50 mg) plus amoxicillin (1000 mg) twice daily for the initial 5 days, followed by esomeprazole (40 mg) or tegoprazan (50 mg) with clarithromycin (500 mg) and metronidazole (500 mg) twice daily for the remaining 5 days. Eradication rate, compliance, and adverse events were recorded.
Results
A total of 406 patients with H. pylori infection were enrolled in the trial and analyzed per protocol. Eradication rate by intention‐to‐treat and per‐protocol was 83.8% (95% confidence interval [CI]: 78.7–88.9) for esomeprazole‐containing sequential therapy, and 87.1% (95% CI: 82.5–91.8) for tegoprazan‐containing sequential therapy, with no statistical significance (p = 0.399). Additionally, there was no statistically significant difference in treatment compliance between the two groups. Nausea was more prevalent (23.3%, 27/202) with sequential tegoprazans than with esomeprazole‐containing sequential therapy (14.2%, 29/204; p = 0.022).
Conclusion
Tegoprazan‐containing 10‐day sequential eradication treatment demonstrated similar eradication efficacy compared to esomeprazole‐containing treatment, even in regions with high antimicrobial resistance, such as Korea.
Trial Registration
ClinicalTrials.gov: NCT06382493