Kazuhiro Ota1, Toshihisa Takeuchi2, Yuichi Kojima2, Shimpei Kawaguchi2, Taro Iwatsubo2, Akitoshi Hakoda2,3, Shinya Nishida2, Shun Sasaki2, Satoshi Kikutani2, Hideki Tawa2, Hideaki Kanaoka2, Naofumi Osaka4, Michiaki Takii5, Koji Nakada6, Kazuhide Higuchi2. 1. Second Department of Internal Medicine, Osaka Medical and Pharmaceutical University, 2-7, Daigaku-machi, Takatsuki, Osaka, 569-8686, Japan. clash_kaz@yahoo.co.jp. 2. Second Department of Internal Medicine, Osaka Medical and Pharmaceutical University, 2-7, Daigaku-machi, Takatsuki, Osaka, 569-8686, Japan. 3. Department of Medical Statistics, Osaka City University Graduate School of Medicine, Osaka, Japan. 4. Central Clinical Laboratory, Osaka Medical and Pharmaceutical University Hospital, Takatsuki, Osaka, Japan. 5. Department of Gastroenterology, Osaka Medical and Pharmaceutical University Mishima-Minami Hospital, Takatsuki, Osaka, Japan. 6. Department of Laboratory Medicine, The Jikei University School of Medicine, Tokyo, Japan.
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).
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).