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.
| Original language | English |
|---|---|
| Pages (from-to) | 1-9 |
| Number of pages | 9 |
| Journal | Journal of Gastroenterology |
| DOIs | |
| Publication status | Accepted/In press - Jun 25 2018 |
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Keywords
- Endoscopic submucosal dissection
- Gastric cancer
- P-CAB
- Potassium-competitive acid blocker
- Vonoprazan
ASJC Scopus subject areas
- Gastroenterology
Cite this
Efficacy of vonoprazan in prevention of bleeding from endoscopic submucosal dissection-induced gastric ulcers : a prospective randomized phase II study. / Hamada, Kenta; Uedo, Noriya; Tonai, Yusuke; Arao, Masamichi; Suzuki, Sho; Iwatsubo, Taro; Kato, Minoru; Shichijo, Satoki; Yamasaki, Yasushi; Matsuura, Noriko; Nakahira, Hiroko; Kanesaka, Takashi; Yamamoto, Sachiko; Akasaka, Tomofumi; Hanaoka, Noboru; Takeuchi, Yoji; Higashino, Koji; Ishihara, Ryu; Okada, Hiroyuki; Iishi, Hiroyasu; Fukui, Keisuke; Shimokawa, Toshio.
In: Journal of Gastroenterology, 25.06.2018, p. 1-9.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Efficacy of vonoprazan in prevention of bleeding from endoscopic submucosal dissection-induced gastric ulcers
T2 - a prospective randomized phase II study
AU - Hamada, Kenta
AU - Uedo, Noriya
AU - Tonai, Yusuke
AU - Arao, Masamichi
AU - Suzuki, Sho
AU - Iwatsubo, Taro
AU - Kato, Minoru
AU - Shichijo, Satoki
AU - Yamasaki, Yasushi
AU - Matsuura, Noriko
AU - Nakahira, Hiroko
AU - Kanesaka, Takashi
AU - Yamamoto, Sachiko
AU - Akasaka, Tomofumi
AU - Hanaoka, Noboru
AU - Takeuchi, Yoji
AU - Higashino, Koji
AU - Ishihara, Ryu
AU - Okada, Hiroyuki
AU - Iishi, Hiroyasu
AU - Fukui, Keisuke
AU - Shimokawa, Toshio
PY - 2018/6/25
Y1 - 2018/6/25
N2 - 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.
AB - 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.
KW - Endoscopic submucosal dissection
KW - Gastric cancer
KW - P-CAB
KW - Potassium-competitive acid blocker
KW - Vonoprazan
UR - http://www.scopus.com/inward/record.url?scp=85049015828&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85049015828&partnerID=8YFLogxK
U2 - 10.1007/s00535-018-1487-6
DO - 10.1007/s00535-018-1487-6
M3 - Article
SP - 1
EP - 9
JO - Journal of Gastroenterology
JF - Journal of Gastroenterology
SN - 0944-1174
ER -