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Comparison of metronidazole versus clarithromycin in first‐line vonoprazan‐based triple therapy for Helicobacter pylori: A multicenter randomized trial in Japan.

Authors :
Sue, Soichiro
Oka, Hiroyuki
Kunishi, Yosuke
Suzuki, Yuichi
Suzuki, Shingo
Kaneko, Takashi
Komatsu, Kazuo
Naito, Makoto
Kato, Yoshio
Sasaki, Tomohiko
Kaneko, Hiroaki
Irie, Kuniyasu
Kondo, Masaaki
Maeda, Shin
Source :
JGH Open; Apr2024, Vol. 8 Issue 4, p1-7, 7p
Publication Year :
2024

Abstract

Background and Aim: To date, no randomized trials have compared the efficacy of 7‐day vonoprazan, amoxicillin, and metronidazole triple therapy (VAM) versus 7‐day vonoprazan, amoxicillin, and clarithromycin triple therapy (VAC) as a first‐line treatment for Helicobacter pylori eradication. This study was performed to compare the efficacy of VAM and VAC as first‐line treatments. Methods: This prospective multicenter randomized trial was performed in Japan and involved 124 H. pylori‐positive patients without a history of eradication. Patients without antibiotic resistance testing of H. pylori were eligible. The patients were randomized to receive either VAC (vonoprazan 20 mg + amoxicillin 750 mg + clarithromycin 200 or 400 mg twice a day) or VAM (vonoprazan 20 mg + amoxicillin 750 mg + metronidazole 250 mg twice a day) for 7 days, with stratification by age and sex. Eradication success was evaluated using the 13C‐urea breath test. We evaluated safety using patient questionnaires (UMIN000025773). Results: The intention‐to‐treat and per‐protocol eradication rates of VAM were 91.3% (95% confidence interval [CI], 82.0–96.7%) and 92.6% (95% CI, 83.7–97.6%), respectively, and those of VAC were 89.1% (95% CI, 77.8–95.9%) and 96.1% (95% CI, 86.5–99.5%), respectively. No significant difference was observed between VAM and VAC in either analysis (P = 0.76 and P = 0.70, respectively). Abdominal fullness was more frequent in patients who received VAM than VAC. Conclusions: These findings suggest that VAM as a first‐line treatment in Japan can be categorized as grade B (intention‐to‐treat cure rate of 90–95%) and have potential as a first‐line national insurance ‐approved regimen. [ABSTRACT FROM AUTHOR]

Details

Language :
English
ISSN :
23979070
Volume :
8
Issue :
4
Database :
Complementary Index
Journal :
JGH Open
Publication Type :
Academic Journal
Accession number :
176869290
Full Text :
https://doi.org/10.1002/jgh3.13069