Randomised trial of acid inhibition by vonoprazan 10/20 mg once daily vs rabeprazole 10/20 mg twice daily in healthy Japanese volunteers (SAMURAI pH study)

Toshihisa Takeuchi, Takahisa Furuta, Yasuhiro Fujiwara, Mitsushige Sugimoto, Kunio Kasugai, Motoyasu Kusano, Hiroyuki Okada, Takahiro Suzuki, Tomohiro Higuchi, Takuma Kagami, Takahiro Uotani, Mihoko Yamade, Akinari Sawada, Fumio Tanaka, Satoshi Harada, Kazuhiro Ota, Yuichi Kojima, Masaki Murata, Yasuhiro Tamura, Yasushi FunakiOsamu Kawamura, Yuki Okamoto, Kazuma Fujimoto, Kazuhide Higuchi

Research output: Contribution to journalArticle

Abstract

Background: Vonoprazan (V), a potassium-competitive acid blocker, has a more durable acid-inhibitory effect as compared with standard-dose proton pump inhibitors (PPIs) but has not been compared with 2-4 times higher daily PPI doses administered in two divided doses. Aims: To evaluate the acid-inhibitory effect of V 10/20 mg once-daily (OD; V10/V20) vs rabeprazole (R) 10/20 mg twice-daily (BID; R20/R40) in healthy Japanese volunteers. Methods: This multicentre, randomised, open-label, two-period, crossover study compared V10 or V20 vs R20, or V20 vs R40 using three cohorts of 10 healthy Japanese adults. Within each cohort, subjects were randomised to receive V or R for 7 days and, following a washout period ≥7 days, the other treatment for 7 days. On day 6 of each period, 24-hours multichannel gastric impedance-pH monitoring was performed. Percent times pH ≥ 3, ≥4 and ≥5 (pH 3, 4 and 5 holding time ratios [HTRs]) in 24 hours were evaluated as primary pharmacodynamic endpoints. Results: Acid-inhibitory effect (24-hours pH 3 HTR) of V20 was greater than those of R20 (91.0% vs 65.3%; P =.0049) and R40 (98.5% vs 85.9%; P =.0073). Similar results were obtained for 24-hours pH 4 and 5 HTRs. V20 also achieved greater nocturnal pH 4 (91.5% vs 73.2%; P =.0319) and 5 HTRs (78.8% vs 62.2%; P =.0325) as compared with R40. One subject (20%) developed diarrhoea while receiving R40 which was considered treatment-related. Conclusions: Compared with 2-4 times the standard daily dose of R, V20 exerts a more potent and durable acid-inhibitory effect. Trial identifier: UMIN000022198 (www.umin.ac.jp/ctr/index.htm).

Original languageEnglish
Pages (from-to)534-543
Number of pages10
JournalAlimentary Pharmacology and Therapeutics
Volume51
Issue number5
DOIs
Publication statusPublished - Mar 1 2020

    Fingerprint

Keywords

  • crossover
  • gastric ph monitoring
  • healthy volunteers
  • rabeprazole
  • vonoprazan

ASJC Scopus subject areas

  • Hepatology
  • Gastroenterology
  • Pharmacology (medical)

Cite this

Takeuchi, T., Furuta, T., Fujiwara, Y., Sugimoto, M., Kasugai, K., Kusano, M., Okada, H., Suzuki, T., Higuchi, T., Kagami, T., Uotani, T., Yamade, M., Sawada, A., Tanaka, F., Harada, S., Ota, K., Kojima, Y., Murata, M., Tamura, Y., ... Higuchi, K. (2020). Randomised trial of acid inhibition by vonoprazan 10/20 mg once daily vs rabeprazole 10/20 mg twice daily in healthy Japanese volunteers (SAMURAI pH study). Alimentary Pharmacology and Therapeutics, 51(5), 534-543. https://doi.org/10.1111/apt.15641