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Administration of a standard dose of vonoprazan fumarate delays gastric emptying in Japanese healthy adults: a prospective clinical trial

Journal of Gastroenterology volume 56, pages 722–731 (2021)Cite this article

Abstract

Background

There is no established view of how gastric acid suppression affects the time for gastric emptying. Vonoprazan fumarate shows potent and durable gastric acid inhibitory effects, but its effects on gastric emptying have not been studied widely. We investigated the effects of vonoprazan fumarate on gastric emptying and measured serum gastrin and plasma ghrelin levels in healthy adults.

Methods

Ten participants were administered 10 mg vonoprazan fumarate daily for 14 days, then 20 mg vonoprazan fumarate daily for 14 days. The gastric emptying breath test was performed and serum gastrin levels were measured at baseline and after each medication administration period. The protocol was then repeated, with the gastric emptying breath test and serum gastrin and plasma desacyl-ghrelin levels measured at baseline and the end of the medication trial.

Results

Mean serum gastrin levels increased in a dose-dependent manner [baseline: 104.7 ± 50.4, after 10 mg protocol: 328 ± 123.8, after 20 mg protocol: 555 ± 378.8 (pg/mL, mean ± standard deviation), p = 0.0008]. There was a significant difference between the gastric emptying breath test Tmax at baseline and just after the 20 mg protocol (baseline: 45.5 ± 15.3, after 20 mg protocol: 60.5 ± 19.6 min, p = 0.0418). Plasma desacyl-ghrelin levels increased significantly just after the 20 mg protocol compared to those at baseline [baseline: 222.3 ± 106.4, after 20 mg protocol: 366.2 ± 178.6 (fmol/mL), p = 0.0008].

Conclusions

In healthy adults, 14 days of vonoprazan fumarate administration at 20 mg/day delayed gastric emptying.

Trial registration

This clinical trial was registered in the University hospital Medical Information Network Clinical Trial Registry (Trial No. UMIN000039199 and UMIN000042969).

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Acknowledgements

We would like to thank the staff of the Central Clinical Laboratory, Osaka Medical and Pharmaceutical University Hospital, who helped us perform the gastric emptying breath test.

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Authors and Affiliations

  1. Second Department of Internal Medicine, Osaka Medical and Pharmaceutical University, 2-7, Daigaku-machi, Takatsuki, Osaka, 569-8686, Japan

    Kazuhiro Ota, Toshihisa Takeuchi, Yuichi Kojima, Shimpei Kawaguchi, Taro Iwatsubo, Akitoshi Hakoda, Shinya Nishida, Shun Sasaki, Satoshi Kikutani, Hideki Tawa, Hideaki Kanaoka & Kazuhide Higuchi

  2. Department of Medical Statistics, Osaka City University Graduate School of Medicine, Osaka, Japan

    Akitoshi Hakoda

  3. Central Clinical Laboratory, Osaka Medical and Pharmaceutical University Hospital, Takatsuki, Osaka, Japan

    Naofumi Osaka

  4. Department of Gastroenterology, Osaka Medical and Pharmaceutical University Mishima-Minami Hospital, Takatsuki, Osaka, Japan

    Michiaki Takii

  5. Department of Laboratory Medicine, The Jikei University School of Medicine, Tokyo, Japan

    Koji Nakada

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  1. Kazuhiro Ota
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Contributions

Guarantor of article: Kazuhiro Ota. Specific author contributions: Kazuhiro Ota, Toshihisa Takeuchi, and Kazuhide Higuchi were involved in the study conception and design. Naofumi Osaka, Michiaki Takii, and Koji Nakada provided the knowledge on the method of the GEBT. Kazuhiro Ota and Akitoshi Hakoda conducted the statistical analysis. Kazuhiro Ota, Shinya Nishda, Taro Iwatsubo, Shimpei Kawaguchi, Shun Sasaki, Satoshi Kikutani, Hideki Tawa, Hideaki Kanaoka, Yuichi Kojima, and Toshihisa Takeuchi were responsible for the collection and inspection of study data. All authors were involved in the interpretation of study results and in the drafting and critical revision of the manuscript. All authors approved the final version of the article, including the authorship list.

Corresponding author

Correspondence to Kazuhiro Ota.

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Conflict of interest

Kazuhide Higuchi received research grants and speaker fees from Otsuka Pharmaceutical Co., Ltd., and Takeda Pharmaceutical Company Ltd. The other authors declare no conflict of interest associated with this manuscript.

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Ota, K., Takeuchi, T., Kojima, Y. et al. Administration of a standard dose of vonoprazan fumarate delays gastric emptying in Japanese healthy adults: a prospective clinical trial. J Gastroenterol 56, 722–731 (2021). https://doi.org/10.1007/s00535-021-01801-3

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  • DOI: https://doi.org/10.1007/s00535-021-01801-3

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