Continuous intravenous infusion of omeprazole in elderly patients with peptic ulcer bleeding - Results of a placebo-controlled multicenter study

Background: Does profound acid inhibition by continuous infusion of omeprazole for 72 h reduce further bleeding in elderly patients with peptic ulcer bleeding (PUB)? Methods: Three hundred and thirty-three patients greater than or equal to 60 years old with PUB were randomized to omeprazole (80 mg + 8 mg/h) or placebo as continuous infusion for 72 h. From day 4 to 21 all patients received 20 mg omeprazole orally once daily. Results: When evaluated on day 3, the primary variable 'overall outcome' (based on an ordinal ranking scale; see Study variables) (P=0.017) and the secondary variables, surgery (P=0.003), degree (P=0.004) and duration of bleeding (P=0.003) all favored the omeprazole group. Blood transfusions, need for endoscopic treatment, and mortality were not statistically different. On follow-up, by day 21, the mortality in the group initially receiving intravenous omeprazole was 6.9%, while the intravenous placebo group showed an extremely low mortality, 0.6%. Conclusion: Three days' infusion of omeprazole improved overall outcome and reduced need for intervention in PUB patients.