Use of Vonoprazan for management of gastric endoscopic submucosal dissection

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Created On: 25/05/2023

gastric endoscopic submucosal dissection

The goal of a multicenter noninferiority randomized controlled trial was to investigate if Vonoprazan therapy for ulcer healing during a 3-week period is non-inferior to treatment over an 8-week period.

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Key take away

For gastric endoscopic submucosal dissection management, treatment with Vonoprazan for three weeks is not inferior to eight weeks.

Background

Method

People with a history of bleeding, those using Vonoprazan, proton pump inhibitors (PPIs), steroids, or non-steroidal anti-inflammatory drugs (NSAIDs) were excluded from the study, whereas, those who underwent stomach endoscopic submucosal dissection (ESD) (aged 20–85 years) were included. Eligible subjects were randomized into Vonoprazan 3w or 8w treatment groups.

The key endpoint was the proportion of patients whose post-ESD wounds were fully healed 24 weeks following ESD. The secondary endpoints included the proportion of individuals with fully healed post-ESD wounds at 8 weeks and the proportion of perforation or bleeding occurring >3 weeks after ESD.

Result

A total of 234 subjects were incorporated. At 8 weeks after therapy, the percentage of people with complete ulcer closure in the 3w group was substantially lower than in the 8w group (70.8% vs. 90.6%). The 3w and 8w group's complete closure rates at 24 weeks were 99.1% and 99.2%, respectively.

The lower limit of the 95% confidence interval (CI) was more than -10%, the preset threshold, and the absolute difference in the closure rate after 24 weeks was -0.059%. Three weeks following ESD, none of the subjects experienced delayed bleeding.

Conclusion

For ulcer healing, Vonoprazan treatment for 3 weeks is adequate to close wounds, is non-inferior to 8 weeks of therapy, and does not cause negative side effects when stopped after 3 weeks.