Efficacy of Vonoprazan vs. Pantoprazole or Non-acid Suppression in Prevention of Post-variceal Ligation Ulcer Bleeding in Portal Hypertension: A Multi-arm Randomized Controlled Trial.

Autor: Lashen SA; Department of Internal Medicine (Hepatology & Gastroenterology Division), Faculty of Medicine, Alexandria University, Alexandria, Egypt., Shamseya MM; Department of Clinical and Experimental Internal Medicine, Medical Research Institute, Alexandria University, Alexandria, Egypt., Shamseya AM; Department of Internal Medicine (Hepatology & Gastroenterology Division), Faculty of Medicine, Alexandria University, Alexandria, Egypt., Hablass FH; Department of Internal Medicine (Hepatology & Gastroenterology Division), Faculty of Medicine, Alexandria University, Alexandria, Egypt.
Jazyk: angličtina
Zdroj: Journal of clinical and experimental hepatology [J Clin Exp Hepatol] 2023 Nov-Dec; Vol. 13 (6), pp. 962-971. Date of Electronic Publication: 2023 May 19.
DOI: 10.1016/j.jceh.2023.05.008
Abstrakt: Background: Up-to-date data about the role of acid suppression therapy e.g. proton-pump inhibitors; to reduce post-endoscopic variceal ligation (EVL) ulcer-bleeding are conflicting. Vonoprazan; a recently introduced potassium-competitor acid blocker, has not been studied to prevent post-EVL ulcer/bleeding. The aim was to evaluate the efficacy of vonoprazan vs. pantoprazole or non-acid suppression to prevent post-EVL ulcer/bleeding in portal hypertension patients.
Material and Methods: We enrolled 275 portal hypertension patients undergoing EVL in a three-arm randomized, single-blind, controlled study. A clinico-laboratory baseline evaluation was performed. Following EVL, patients were randomly and equally assigned to receive vonoprazan 20mg once daily, pantoprazole 40 mg once daily, or no acid suppression therapy. Post-EVL ulcer bleeding, ulcer dimensions, odynophagia as well as vonoprazan safety were evaluated after 2 weeks of EVL.
Results: Post-EVL ulcer bleeding occurred among 2.15% of vonoprazan, 8.7% of pantoprazole, and 14.2% of the non-acid suppression groups ( P  < 0.001). Post-ligation ulcer frequency and dimensions were higher among non-acid suppression and pantoprazole groups vs. vonoprazan ( P  < 0.05). Chest pain and odynophagia were encountered among 73.6% and 54.9% of the non-acid suppression group vs. 39.6% and 45.1% in pantoprazole, and 17.2% and 21.5% in vonoprazan groups, respectively ( P  < 0.05). There were no vonoprazan-related adverse events. Non-use of vonoprazan was the strongest independent predictor for post-EVL bleeding.
Conclusion: Short course of vonoprazan 20 mg/day is safe and superior to pantoprazole 40 mg/day in the reduction of post-EVL ulcer dimensions at 2 weeks post-EVL, and prevention of ulcer-related bleeding. Acid suppression is superior to no acid suppression to prevent post-EVL complications.
(© 2023 Indian National Association for Study of the Liver. Published by Elsevier B.V. All rights reserved.)
Databáze: MEDLINE