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. 2024 Apr 22;8(4):e13069.
doi: 10.1002/jgh3.13069. eCollection 2024 Apr.

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

Soichiro Sue  1 , Hiroyuki Oka  2 , Yosuke Kunishi  3 , Yuichi Suzuki  1   4 , Shingo Suzuki  5 , Takashi Kaneko  2   6 , Kazuo Komatsu  4 , Makoto Naito  5 , Yoshio Kato  3 , Tomohiko Sasaki  1 , Hiroaki Kaneko  1 , Kuniyasu Irie  1 , Masaaki Kondo  2 , Shin Maeda  1
Affiliations

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

Soichiro Sue et al. JGH Open. .

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.

Keywords: 7‐day triple therapy; Helicobacter pylori; clarithromycin; metronidazole; vonoprazan.

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Figures

Figure 1
Figure 1
Flowchart of patient enrollment. In total, 124 patients were randomized and treated with either VAM triple therapy or VAC triple therapy. Five patients dropped out or interrupted their therapy. VAC triple therapy: vonoprazan + amoxicillin + clarithromycin 1‐week eradication therapy; VAM triple therapy: vonoprazan + amoxicillin + metronidazole 1‐week eradication therapy.
Figure 2
Figure 2
Eradication rates of VAM triple therapy and VAC triple therapy in ITT and PP analyses. No significant differences were observed between VAM and VAC in either the ITT or PP analyses. ITT, intention‐to‐treat; PP, per‐protocol; VAC triple therapy: vonoprazan + amoxicillin + clarithromycin 1‐week eradication therapy; VAM triple therapy: vonoprazan + amoxicillin + metronidazole 1‐week eradication therapy.
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References

    1. Sue S, Shibata W, Maeda S. Helicobacter pylori‐induced signaling pathways contribute to intestinal metaplasia and gastric carcinogenesis. Biomed. Res. Int. 2015; 2015: 737621. - PMC - PubMed
    1. Ford AC, Yuan Y, Moayyedi P. Helicobacter pylori eradication therapy to prevent gastric cancer: systematic review and meta‐analysis. Gut. 2020; 69: 2113–2121. - PubMed
    1. Lee YC, Chiang TH, Chou CK et al. Association between Helicobacter pylori eradication and gastric cancer incidence: a systematic review and meta‐analysis. Gastroenterology. 2016; 150: 1113–1124.e5. - PubMed
    1. Malfertheiner P, Megraud F, Rokkas T et al. Management of Helicobacter pylori infection: the Maastricht VI/Florence consensus report. Gut. 2022; 71: 1724–1762.
    1. Kato M, Ota H, Okuda M et al. Guidelines for the management of Helicobacter pylori infection in Japan: 2016 revised edition. Helicobacter. 2019; 24: e12597. - PubMed