Efficacy of vonoprazan against bleeding from endoscopic submucosal dissection-induced gastric ulcers under antithrombotic medication: A cross-design synthesis of randomized and observational studies

Abstract

Vonoprazan, a potassium-competitive acid blocker, is expected to be superior to proton pump inhibitors (PPIs) in preventing post-endoscopic submucosal dissection (ESD)-induced gastric bleeding. However, the results of randomized controlled trials (RCTs) and observational studies on the efficacy of vonoprazan have been inconsistent. This study aimed to evaluate the effectiveness of vonoprazan in antithrombotic drug users, a population that has been excluded from RCTs. Treatment effects were assessed using cross-design synthesis, which can be adjusted for differences in study design and patient characteristics. We used data from an RCT in Japan (70 patients in the vonoprazan group and 69 in the PPI group) and an observational study (408 patients in the vonoprazan group and 870 in the PPI group). After matching, among the antithrombotic drug users in the observational study, post-ESD bleeding was noted in 8 out of 86 patients in the vonoprazan group and 18 out of 86 patients in the PPI group. After pooling the data from the RCT and observational study, the risk difference for antithrombotic drug users was -14.6% (95% CI: -22.0 to -7.2). CDS analysis suggested that vonoprazan is more effective than PPIs in preventing post-ESD bleeding among patients administered antithrombotic medications.

Potassium-competitive acid blockers and acid-related disorders

“…Studies in Asia have established noninferiority of PCABs for gastric and duodenal ulcers, but not superiority [21 ▪ ]. Additionally, PCABs have been studied for prevention of bleeding after endoscopic submucosal dissection, though studies have been inconsistent in showing superiority over PPIs [39,40]. Theoretically, PCABs could be useful for Barrett's esophagus, but this has not specifically reported in the published literature.…”

Vonoprazan - a new drug for inhibiting gastric acid secretion

“…Clinical trial conducted by T. Kagawa et al proved that vonoprazan is effective in reducing post-ESD bleeding and is more effective than PPIs [21]. Y. Hidaka et al investigated RCT that proved that for patients treated with antithrombotic drugs, vonoprazan is more effective in preventing bleeding from post-ESD gastric ulcers than PPIs [22].…”

Endoscopic treatment of bleeding gastric ulcer causing gastric wall necrosis: A case report

“…Bleeding is a prevalent complication of gastric ulcers, with an incidence rate of approximately 30%-50%[ 1 ]. Currently, endoscopic treatment is the preferred method for managing gastric ulcer bleeding.…”