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Published in: Journal of Gastroenterology 2/2019

01-02-2019 | Original Article—Alimentary Tract

Efficacy of vonoprazan in prevention of bleeding from endoscopic submucosal dissection-induced gastric ulcers: a prospective randomized phase II study

Authors: Kenta Hamada, Noriya Uedo, Yusuke Tonai, Masamichi Arao, Sho Suzuki, Taro Iwatsubo, Minoru Kato, Satoki Shichijo, Yasushi Yamasaki, Noriko Matsuura, Hiroko Nakahira, Takashi Kanesaka, Sachiko Yamamoto, Tomofumi Akasaka, Noboru Hanaoka, Yoji Takeuchi, Koji Higashino, Ryu Ishihara, Hiroyuki Okada, Hiroyasu Iishi, Keisuke Fukui, Toshio Shimokawa

Published in: Journal of Gastroenterology | Issue 2/2019

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Abstract

Background

Vonoprazan, potassium-competitive acid blocker, is expected to reduce incidence of delayed bleeding after gastric endoscopic submucosal dissection (ESD); however, preliminary data to design a large-scale comparative study are lacking. This study aimed to assess the efficacy of vonoprazan in preventing delayed bleeding after gastric ESD.

Methods

In this single-center randomized phase II trial, a modified screened selection design was used with a threshold non-bleeding rate of 89% and an expected rate of 97%. In this design, Simon’s optimal two-stage design was first applied for each parallel group, and efficacy was evaluated in comparison with the threshold rate using binomial testing. Patients were randomly assigned in a 1:1 ratio to receive either vonoprazan 20 mg (VPZ group) or lansoprazole 30 mg (PPI group) for 8 weeks from the day before gastric ESD. The primary endpoint was the incidence of delayed bleeding, defined as endoscopically confirmed bleeding accompanied by hematemesis, melena, or a decrease in hemoglobin of ≥ 2 g/dl.

Results

Delayed bleeding occurred in three of 69 patients (4.3%, 95% CI 0.9–12.2%, p = 0.047) in the VPZ group, and four of 70 (5.7%, 95% CI 1.6–14.0%, p = 0.104) in the PPI group. As only vonoprazan showed significant reduction in delayed bleeding compared with the threshold rate, it was determined to be efficacious treatment.

Conclusions

Vonoprazan efficaciously reduced the delayed bleeding rate in patients with an ESD-induced gastric ulcer. A large-scale, randomized, phase III study is warranted to definitively test the effectiveness of vonoprazan compared with proton pump inhibitors.
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Metadata
Title
Efficacy of vonoprazan in prevention of bleeding from endoscopic submucosal dissection-induced gastric ulcers: a prospective randomized phase II study
Authors
Kenta Hamada
Noriya Uedo
Yusuke Tonai
Masamichi Arao
Sho Suzuki
Taro Iwatsubo
Minoru Kato
Satoki Shichijo
Yasushi Yamasaki
Noriko Matsuura
Hiroko Nakahira
Takashi Kanesaka
Sachiko Yamamoto
Tomofumi Akasaka
Noboru Hanaoka
Yoji Takeuchi
Koji Higashino
Ryu Ishihara
Hiroyuki Okada
Hiroyasu Iishi
Keisuke Fukui
Toshio Shimokawa
Publication date
01-02-2019
Publisher
Springer Japan
Published in
Journal of Gastroenterology / Issue 2/2019
Print ISSN: 0944-1174
Electronic ISSN: 1435-5922
DOI
https://doi.org/10.1007/s00535-018-1487-6

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