Omeprazole for peptic ulcer bleeding
Trial question
What is the role of intravenous omeprazole in patients having undergone endoscopic treatment for bleeding peptic ulcers?
Study design
Single center
Double blinded
RCT
Population
Characteristics of study participants
33.0% female
67.0% male
N = 240
240 patients (80 female, 160 male).
Inclusion criteria: patients having undergone endoscopic treatment for bleeding peptic ulcers.
Key exclusion criteria: unsuccessful endoscopic treatment, terminal cancer, moribund state, or unwilling to provide consent.
Interventions
N=120 omeprazole (as a bolus intravenous injection of 80 mg followed by an infusion of 8 mg per hour for 72 hours).
N=120 placebo (matching placebo IV for 72 hours).
Primary outcome
Rate of bleeding recurrence within 30 days
6.7%
22.5%
22.5 %
16.9 %
11.3 %
5.6 %
0.0 %
Omeprazole
Placebo
Significant
decrease ▼
NNT = 6
Significant decrease in the rate of bleeding recurrence within 30 days (6.7% vs. 22.5%; HR 0.25, 95% CI 0.11 to 0.58).
Secondary outcomes
Borderline significant decrease in death at 30 days (4.2% vs. 10%; RR 0.42, 95% CI -0.12 to 0.96).
Conclusion
In patients having undergone endoscopic treatment for bleeding peptic ulcers, omeprazole was superior to placebo with respect to the rate of bleeding recurrence within 30 days.
Reference
Lau JY, Sung JJ, Lee KK et al. Effect of intravenous omeprazole on recurrent bleeding after endoscopic treatment of bleeding peptic ulcers. N Engl J Med. 2000 Aug 3;343(5):310-6.
Open reference URL