Efficacy similar between oral, IV esomeprazole for peptic ulcer bleeding after endoscopy
Proton-pump inhibitor esomeprazole achieved similar success of hemostasis whether administered orally or intravenously in patients with peptic ulcer bleeding after endoscopy, according to research data.
Researchers from the Institute of Digestive Disease at the Chinese University of Hong Kong conducted a prospective randomized, double blind, double-dummy study of adult patients hospitalized at Prince of Wales Hospital during a 60-month period for actively bleeding peptic ulcer, ulcer with protuberant vessel or adherent blood clot.
After endoscopic intervention to control bleeding, included patients were randomly assigned to the IVP group (n=118), who received esomeprazole IV bolus at 80 mg plus infusion at 8 mg per hour for 72 hours and oral placebo every 12 hours, or to the ORP group (n=126), who received IV placebo bolus plus infusion for 72 hours and 40 mg oral esomeprazole every 12 hours. After day 4, all patients received 40 mg oral esomeprazole daily until the end of the 30-day follow-up.
IVP vs. ORP recurrent bleeding rates were similar at 72 hours (5.1% vs. 2.4%; P=.26) and 7 days (6.8% vs. 5.6%; P=.68). Within 30 days, 7.7% of IVP patients had recurrent bleeding compared with 6.4% of ORP patients (–1.3% risk difference; 95% CI, –7.7% to 5.1%). Blood transfusion (P=.65), repeated endoscopy (P=1) and hospital stay (P=.8) also were similar between groups.
While comparable efficacy was shown between IV and oral esomeprazole, the researchers said “the targeted sample size was not reached, and this study was not designed as an equivalency study.” They also concluded that before data from a larger equivalency study are available, “high-dose oral esomeprazole at 40 mg [twice daily] may be considered as a useful alternative in the management of ulcer bleeding in patients who are not candidates for high-dose IV PPI infusion.”
Disclosure: The researchers report no relevant financial disclosures.