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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.

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제1저자 이정원 · 교신저자 김나영

PMID 39434634 DOI 10.1111/hel.13143 IF 4.6 소화기내과
소속 (4)
  1. Department of Internal Medicine, Samsung Changwon Hospital, Sungkyunkwan University School of Medicine, Changwon, South Korea.
  2. Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, South Korea.
  3. Research Center for Sex- and Gender-Specific Medicine, Seoul National University Bundang Hospital, Seongnam, South Korea.
  4. 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
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