Publication: Comparison of Vonoprazan Versus Intravenous Proton Pump Inhibitor for Prevention of High-Risk Peptic Ulcers Rebleeding After Successful Endoscopic Hemostasis: A Multicenter Randomized Noninferiority Trial
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Issued Date
2024-09-01
Resource Type
ISSN
00165085
eISSN
15280012
Scopus ID
2-s2.0-85199082857
Pubmed ID
38582271
Journal Title
Gastroenterology
Volume
167
Issue
4
Start Page
778
End Page
787.e3
Rights Holder(s)
SCOPUS
Bibliographic Citation
Gastroenterology Vol.167 No.4 (2024) , 778-787.e3
Suggested Citation
Geeratragool T., Kaosombatwattana U., Boonchote A., Chatthammanat S., Preechakawin N., Srichot J., Sudcharoen A., Sirisunhirun P., Termsinsuk P., Rugivarodom M., Limsrivilai J., Maneerattanaporn M., Pausawasdi N., Leelakusolvong S. Comparison of Vonoprazan Versus Intravenous Proton Pump Inhibitor for Prevention of High-Risk Peptic Ulcers Rebleeding After Successful Endoscopic Hemostasis: A Multicenter Randomized Noninferiority Trial. Gastroenterology Vol.167 No.4 (2024) , 778-787.e3. 787.e3. doi:10.1053/j.gastro.2024.03.036 Retrieved from: https://hdl.handle.net/20.500.14740/20119
Corresponding Author(s)
Other Contributor(s)
Abstract
Background & Aims: High-dose proton pump inhibitor (PPI) therapy has been recommended to prevent rebleeding of high-risk peptic ulcer (PU) after hemostasis. Vonoprazan has been proven to be noninferior to PPIs in various acid-related diseases. This study aimed to compare the efficacy of vonoprazan vs PPI for preventing high-risk PU rebleeding after hemostasis. Methods: A multicenter, randomized, noninferiority study was conducted in 6 centers. Pre-endoscopic and endoscopic therapy were performed according to standard protocol. After successful hemostasis, patients with high-risk PU bleeding (Forrest class Ia/Ib, IIa/IIb) were randomized into 1:1 to receive vonoprazan (20 mg twice a day for 3 days, then 20 mg once a day for 28 days) or high-dose PPI (pantoprazole intravenous infusion 8 mg/h for 3 days, then omeprazole 20 mg twice a day for 28 days). The primary outcome was a 30-day rebleeding rate. Secondary outcomes included 3- and 7-day rebleeding rate, all-cause and bleeding-related mortality, rate of rescue therapy, blood transfusion, length of hospital stay, and safety. Results: Of 194 patients, baseline characteristics, severity of bleeding, and stage of ulcers were comparable between the 2 groups. The 30-day rebleeding rates in vonoprazan and PPI groups were 7.1% (7 of 98) and 10.4% (10 of 96), respectively; noninferiority (within 10% margin) of vonoprazan to PPI was confirmed (%risk difference, −3.3; 95% confidence interval, −11.2 to 4.7; P < .001). The 3-day and 7-day rebleeding rates in the vonoprazan group remained noninferior to PPI (P < .001 by Farrington and Manning test). All secondary outcomes were also comparable between the 2 groups. Conclusion: In patients with high-risk PU bleeding, the efficacy of vonoprazan in preventing 30-day rebleeding was noninferior to intravenous PPI. (ClinicalTrials.gov, Number: NCT05005910)