Helicobacter. 2024;29(5):e13143.
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.
제1저자 이정원 · 교신저자 김나영
소속 (4)
- Department of Internal Medicine, Samsung Changwon Hospital, Sungkyunkwan University School of Medicine, Changwon, South Korea.
- Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, South Korea.
- Research Center for Sex- and Gender-Specific Medicine, Seoul National University Bundang Hospital, Seongnam, South Korea.
- Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, South Korea.
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.
© 2024 The Author(s). Helicobacter published by John Wiley & Sons Ltd.
Keywords
Helicobacter pylorieradicationesomeprazolesequential therapytegoprazan
그 밖의 정보
- 출판 형태
- Journal Article, Randomized Controlled Trial, Comparative Study
- 저널
- Helicobacter · eISSN 1523-5378
- MeSH
- Humans · Helicobacter Infections* / drug therapy · Republic of Korea · Male · Female · Esomeprazole* / therapeutic use / administration & dosage · Middle Aged · Helicobacter pylori* / drug effects · Anti-Bacterial Agents* / therapeutic use / administration & dosage · Prospective Studies · Aged · Drug Therapy, Combination* · Treatment Outcome · Adult · Drug Resistance, Bacterial · Tertiary Care Centers · Metronidazole / therapeutic use / administration & dosage · Proton Pump Inhibitors / therapeutic use / administration & dosage · Amoxicillin / therapeutic use / administration & dosage · Clarithromycin / therapeutic use / administration & dosage · Pyrroles · Sulfonamides
- Substances
- Esomeprazole · Anti-Bacterial Agents · 1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine · Metronidazole · Proton Pump Inhibitors · Amoxicillin · Clarithromycin · Pyrroles · Sulfonamides
- 연구비
- the National Research Foundation of Korea (NRF) RS-2024-00337453 · the Korean government (MSIT)
- 데이터
- ClinicalTrials.gov: NCT06382493
- 참고문헌
- 39편