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Intravenous esomeprazole for prevention of peptic ulcer re-bleeding: rationale/design of Peptic Ulcer Bleed study.

Author(s): Sung JJ, Mossner J, Barkun A, Kuipers EJ, Lau J, Jensen D, Stuart R, Junghard O, Olsson G, Pub Study Group

Affiliation(s): Institute of Digestive Diseases, Chinese University of Hong Kong, Shatin, Hong Kong, China. joesung@cuhk.edu.hk

Publication date & source: 2008-04, Aliment Pharmacol Ther., 27(8):666-77. Epub 2008 Jan 28.

Publication type: Research Support, Non-U.S. Gov't

BACKGROUND: A limited number of trials have investigated the efficacy of proton pump inhibitors for peptic ulcer bleeding, and some study design issues have been identified. AIM: To present the design of a large trial evaluating the effects of intravenous esomeprazole on clinical outcomes in high-risk patients who have undergone endoscopic haemostasis for peptic ulcer bleeding. METHODS: The Peptic Ulcer Bleed study is an international, randomized, double-blind, placebo-controlled trial comparing either esomeprazole 80 mg intravenous bolus infusion for 30 min followed by esomeprazole 8 mg/h intravenously for 71.5 h, or placebo infusion for 72 h, after successful endoscopic haemostasis in patients with peptic ulcer bleeding and associated high-risk stigmata. All patients will receive once daily oral esomeprazole 40 mg for 27 days after intravenous therapy. The primary end point is the rate of clinically significant re-bleeding during the first 72 h after endoscopy. Secondary end points include: rate of re-bleeding during the first 7 and 30 days after treatment; length of hospitalization; mortality; blood transfusion; endoscopic re-treatment and surgery. RESULTS: Expected 2008. CONCLUSIONS: The carefully designed protocol and quality control measures represent a pragmatic approach to contemporary challenges in peptic ulcer bleeding management and, it is hoped, qualify the Peptic Ulcer Bleed study as a new standard for future interventional studies.

Page last updated: 2008-03-26

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