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A study for every second day administration of vonoprazan for maintenance treatment of erosive GERD (ESD von GERD): a multicenter randomized cross-over study

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Abstract

Background

Vonoprazan is a potassium competitive acid blocker used to treat erosive gastroesophageal reflux disease (GERD) with stronger, more stable acid-suppressing effects than proton pump inhibitors (PPIs). This study clarified the usefulness and superiority of vonoprazan administered every second day over PPIs in the maintenance therapy of erosive GERD.

Methods

This is a prospective, multicenter, open-label, two-period randomized cross-over study. Patients were randomized to either the vonoprazan-lansoprazole (VP-LZ) group, who were given vonoprazan 10 mg for the first 4 weeks and then lansoprazole 15 mg for the next 4 weeks both administered once every second day, or the lansoprazole-vonoprazan (LZ-VP) group, who were treated in reverse. GERD symptoms were compared using symptom diaries, the frequency scale for symptoms of GERD (FSSG), and the gastrointestinal symptom rating scale (GSRS).

Results

We enrolled 122 patients between December 2017 and May 2019. Symptoms were well controlled in vonoprazan administration and lansoprazole administration were 93.6% and 82.1%, respectively, with a significant difference on McNemar’s test (P = 0.003). During the second 4 weeks, 94.4% and 76.7% of patients in the VP-LZ and LZ-VP groups, respectively, were well controlled following for ≥ 6 consecutive days a week (P = 0.009). During the first 4 weeks, 96.7% and 80.0% of patients were well controlled with < 1 weekly in the VP-LZ and LZ-VP groups, respectively, during the first 4 weeks (P = 0.007). GERD symptoms, assessed via FSSG and GSRS, significantly decreased with vonoprazan administration once every second day.

Conclusions

Vonoprazan administered once every second day could be an effective alternative to PPIs in the maintenance treatment of erosive GERD (UMIN000030393).

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Acknowledgements

The corresponding author would like to thank Noriko Ito for statistical calculations and advice in this study.

Author information

Authors and Affiliations

  1. Department of Gastroenterology, National Hospital Organization Hakodate National Hospital, 18-16, Kawahara-chou, Hakodate, Hokkaido, 041-8512, Japan

    Soichiro Matsuda, Mototsugu Kato, Kimitoshi Kubo & Katsuhiro Mabe

  2. Department of Gastroenterology, National Hospital Organization Osaka National Hospital, Osaka, Japan

    Yuko Sakakibara

  3. Department of Gastroenterology, National Hospital Organization Higashihiroshima Medical Center, Hiroshima, Japan

    Hiroshige Hamada

  4. Department of Gastroenterology, National Hospital Organization Disaster Medical Center, Tokyo, Japan

    Yoshihiro Sasaki

  5. Department of Gastroenterology, National Hospital Organization Tokyo Medical Center, Tokyo, Japan

    Hideki Mori & Yuichiro Hirai

  6. Department of Gastroenterology, National Hospital Organization Kochi National Hospital, Kochi, Japan

    Shuji Inoue

  7. Department of Gastroenterology, National Hospital Organization Fukuyama Medical Center, Hiroshima, Japan

    Tatsuya Toyokawa

  8. Department of Gastroenterology, National Hospital Organization Kanazawa Medical Center, Ishikawa, Japan

    Takashi Kagaya

  9. Department of Gastroenterology, National Hospital Organization Kure Medical Center, Hiroshima, Japan

    Toshio Kuwai

  10. Department of Gastroenterology, National Hospital Organization Kyoto Medical Center, Kyoto, Japan

    Naoki Esaka

  11. Department of Gastroenterology, National Hospital Organization Okayama Medical Center, Okayama, Japan

    Haruhiro Yamashita

  12. Department of Gastroenterology, National Hospital Organization Mie Chou Medical Center, Mie, Japan

    Noriko Watanabe

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

    Mio Matsumoto

  14. Department of Gastroenterology, National Hospital Organization Fukuokahigashi Medical Center, Fukuoka, Japan

    Hiroyuki Fujii

  15. Department of Clinical Research, National Hospital Organization Hakodate National Hospital, Hokkaido, Japan

    Mamiko Demura

  16. Department of Gastroenterology, National Hospital Organization Kyushu Medical Center, Fukuoka, Japan

    Naohiko Harada

Authors
  1. Soichiro Matsuda
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  2. Mototsugu Kato
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  3. Yuko Sakakibara
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  18. Kimitoshi Kubo
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  19. Katsuhiro Mabe
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  20. Naohiko Harada
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Corresponding author

Correspondence to Mototsugu Kato.

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Matsuda, S., Kato, M., Sakakibara, Y. et al. A study for every second day administration of vonoprazan for maintenance treatment of erosive GERD (ESD von GERD): a multicenter randomized cross-over study. J Gastroenterol 57, 133–143 (2022). https://doi.org/10.1007/s00535-022-01850-2

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  • DOI: https://doi.org/10.1007/s00535-022-01850-2

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