Randomized controlled trial of standard versus high-dose intravenous omeprazole after endoscopic therapy in high-risk patients with acute peptic ulcer bleeding

Background: Rebleeding from peptic ulcers is a major contributor to death. This study compared standard (40-mg intravenous infusion of omeprazole once daily for 3 days) and high-dose (80-mg bolus of omeprazole followed by 8-mg/h infusion for 72 h) in reducing the rebleeding rate (primary endpoint), need for surgery, duration of hospital stay and mortality in patients with peptic ulcer bleeding after successful endoscopic therapy. Methods: This was a single-institution prospective randomized controlled study based on a postulated therapeutic equivalence of the two treatments. All patients who had successful endoscopic haemostasis of a bleeding peptic ulcer (Forrest classification Ia, Ib, IIa or IIb) were recruited. Informed consent was obtained and patients were randomized to receive standard- or high-dose infusions of intravenous omeprazole. Results: Two (3 per cent) of 61 patients in the high-dose group and ten (16 per cent) of 61 in the standard-dose group exhibited rebleeding, a difference of -13 (95 per cent confidence interval -25 to -2) per cent. The upper limit of the one-sided confidence interval exceeded a predefined equivalence absolute difference of 16 per cent. Equivalence of standard- and high-dose omeprazole in preventing rebleeding was not demonstrated. Conclusion: Intravenous standard-dose omeprazole was inferior to high-dose omeprazole in preventing rebleeding after endoscopic haemostasis for peptic ulcer bleeding. Registration number: NCT00519519 (http://www.clinicaltrials.gov).