1. Efficacy of vonoprazan in prevention of bleeding from endoscopic submucosal dissection-induced gastric ulcers: a prospective randomized phase II study.
- Author
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Hamada K, Uedo N, Tonai Y, Arao M, Suzuki S, Iwatsubo T, Kato M, Shichijo S, Yamasaki Y, Matsuura N, Nakahira H, Kanesaka T, Yamamoto S, Akasaka T, Hanaoka N, Takeuchi Y, Higashino K, Ishihara R, Okada H, Iishi H, Fukui K, and Shimokawa T
- Subjects
- Aged, Endoscopic Mucosal Resection adverse effects, Female, Hematemesis blood, Hematemesis etiology, Hematemesis prevention & control, Hemoglobins metabolism, Humans, Lansoprazole therapeutic use, Male, Melena blood, Melena etiology, Melena prevention & control, Middle Aged, Postoperative Hemorrhage blood, Postoperative Hemorrhage etiology, Prospective Studies, Stomach Ulcer complications, Postoperative Hemorrhage prevention & control, Proton Pump Inhibitors therapeutic use, Pyrroles therapeutic use, Stomach Neoplasms surgery, Stomach Ulcer drug therapy, Sulfonamides therapeutic use
- 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.
- Published
- 2019
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