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Efficacy and safety of vonoprazan-based regimen for Helicobacter pylori eradication therapy in Japanese adolescents: a prospective multicenter study

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Abstract

Background

Vonoprazan (VPZ)-based regimen for Helicobacter pylori (H. pylori) is safe and more efficacious than the proton pump inhibitor-based regimen mainly in adults. This study aimed to evaluate the efficacy and safety of a VPZ-based regimen for H. pylori eradication therapy in adolescents.

Methods

An H. pylori screening and treatment longitudinal project for third-year junior high school students in Saga Prefecture began in 2016. Students who tested positive for both urine and stool tests received a VPZ-based regimen. On the checklist, students were asked for diarrhea, fever, abdominal pain, nausea, vomiting, urticaria, dysgeusia, or bloody stool occurrence during the therapy.

Results

The longitudinal project for H. pylori screening and treatment among third-grade students in Saga Prefecture targeted 41,115 students from 2017 to 2021 and 836 as positive. Of the 645 students, 542 (84.0% in per protocol [PP] analysis and 73.6% in intention-to-treat [ITT] analysis) were successful in primary eradication therapy. The secondary eradication therapy was successful in 79 (96.3% in PP analysis and 76.7% in ITT analysis) of 82 students. In the primary eradication therapy, abdominal pain occurred in 164 (27.9%), diarrhea in 217 (36.9%), nausea or vomiting in 7 (1.2%), and urticaria in 13 (2.2%) students. In the secondary eradication therapy, abdominal pain occurred in 12 (19.4%) and diarrhea in 17 (27.4%) students. The eradication therapy of 5 students was interrupted due to adverse events only by primary eradication therapy.

Conclusions

VPZ-based regimen for H. pylori was efficacious and safe for adolescents, as in adults, for both primary and secondary eradication therapies.

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Data availability

The original contributions presented in the study are included in the article. Further inquiries can be directed to the corresponding author.

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Acknowledgements

We would like to thank the outpatient nurses and medical support staff of the participating medical institutions. We are also grateful to the project center’s staff, Ms. Kozue Kakiuchi and Ms. Ikumi Miyachi, for their assistance with the project.

Funding

This project was supported by public grants from the government of Saga Prefecture.

Author information

Authors and Affiliations

  1. Departments of Pediatrics, Faculty of Medicine, Saga University, Saga, Japan

    Toshihiko Kakiuchi & Muneaki Matsuo

  2. Department of Internal Medicine, Saiseikai Karatsu Hospital, Karatsu, Japan

    Hiroyoshi Endo

  3. Division of Gastroenterology, Department of Internal Medicine, Faculty of Medicine, Saga University, Saga, Japan

    Yasuhisa Sakata & Motohiro Esaki

  4. Department of Internal Medicine, Karatsu Red Cross Hospital, Karatsu, Japan

    Takahiro Noda

  5. Department of Gastroenterology, Imamura Hospital, Tosu, Japan

    Ichiro Imamura & Kazutoshi Hashiguchi

  6. Department of Gastroenterology, Saga-Ken Medical Centre Koseikan, Saga, Japan

    Shinichi Ogata

  7. Department of Gastroenterology, Fujioka Hospital, Saga, Japan

    Yasuhiko Fujioka

  8. Department of Surgery, Hashimoto Hospital, Kanzaki, Japan

    Keiichiro Hanada

  9. Department of Gastroenterology, Hiramatsu Hospital, Ogi, Japan

    Kayoko Fukuda

  10. Department of Gastroenterology, National Hospital Organization East Saga Hospital, Miyaki, Japan

    Masaya Yoshimura

  11. Department of Gastroenterology, Shiroishikyoritsu Hospital, Shiroishi, Japan

    Tetsuro Kajiwara

  12. Department of Surgery, Yamamoto Memorial Hospital, Imari, Japan

    Kentaroh Yamamoto

  13. Department of Gastroenterology, National Hospital Organization Ureshino Medical Center, Ureshino, Japan

    Daisuke Yamaguchi

  14. Department of Gastroenterology, Imari Arita Kyouritsu Hospital, Arita, Japan

    Hiroharu Kawakubo

  15. Department of Internal Medicine, National Hospital Organization Saga Hospital, Saga, Japan

    Takuya Matsunaga

  16. Department of Internal Medicine, Inutsuka Hospital, Kashima, Japan

    Michihiro Sumino

  17. Department of Gastroenterology, Oda Hospital, Kashima, Japan

    Keiji Matsunaga

  18. Departments of Pediatrics, Takashima Hospital, Shiroishi, Japan

    Eriko Muro

  19. Department of Internal Medicine, Taku City Hospital, Taku, Japan

    Akira Watanabe

  20. Department of Gastroenterology, International University of Health and Welfare, Okawa, Japan

    Kazuma Fujimoto

Authors
  1. Toshihiko Kakiuchi
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  2. Muneaki Matsuo
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Contributions

Guarantor of the article: TK. Conceptualization, data analysis, and manuscript preparation: TK, MM, ME, HE, and KF. Data collection: TK, HE, YS, TN, II, KH, SO, YF, KH, KF, MY, TKaj, KY, DY, HK, TM, MS, KM, EM, and AW. Critical manuscript review: MM, ME, and KF. All authors have read and approved the submitted version.

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Correspondence to Toshihiko Kakiuchi.

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The authors declare that they have no conflicts of interest. This study received no financial support.

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Kakiuchi, T., Matsuo, M., Endo, H. et al. Efficacy and safety of vonoprazan-based regimen for Helicobacter pylori eradication therapy in Japanese adolescents: a prospective multicenter study. J Gastroenterol 58, 196–204 (2023). https://doi.org/10.1007/s00535-022-01942-z

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