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.

dx.doi.org/10.1111/j.1365-2036.2008.03631.x, hdl.handle.net/1765/29533
Alimentary Pharmacology and Therapeutics
Erasmus MC: University Medical Center Rotterdam

Sung, J.J.Y, Mössner, J, Barkun, A.N, Kuipers, E.J, Lau, J.Y.W, Jensen, D.M, … Olsson, G. (2008). Intravenous esomeprazole for prevention of peptic ulcer re-bleeding: Rationale/design of peptic ulcer bleed study. Alimentary Pharmacology and Therapeutics, 27(8), 666–677. doi:10.1111/j.1365-2036.2008.03631.x