EBQ:Omeprazole in Bleeding Peptic Ulcers

incomplete Journal Club Article

Lau JYW, et al. "Effect of Intravenous Omeprazole on Recurrent Bleeding after Endoscopic Treatment of Bleeding Peptic Ulcer". NEJM. 2000. 343(5):310-316.
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Clinical Question

Does high dose intravenous omeprazole reduce the incidence of recurrent bleeding in patients who have undergone endoscopic intervention for bleeding peptic ulcers?

Conclusion

High-dose infusion of omeprazole after endoscopic treatment of bleeding peptic ulcers substantially reduces the risk of recurrent bleeding.

Study Design

• Randomized, double-blind, placebo-controlled study
• From May 1998 to July 1999, all patient admitted to Prince of Wales Hospital with upper GI bleed were treated jointly by a team of physicians and surgeons
• Patients underwent endoscopy within 24 hours after admission

Population

Patient Demographics

Omeprazole vs. Placebo
Male: 66.7% vs. 66.7%
Age: 64 vs. 67
Hemoglobin (g/dL): 9.4 vs. 9.5
Location of ulcer:

Stomach: 44% vs. 40%

Duodenum: 54% vs. 54%

Stoma: 2% vs. 6%

Endoscopic signs of bleeding:

Spurting hemorrhage: 12% vs. 8%

Oozing hemorrhage: 42% vs. 41%

Nonbleeding visible vessel: 32% vs. 30%

Clot with underlying vessel: 15% vs. 22%

Size of ulcer (cm): 1.2 vs. 1.1
Previous ulcer disease: 32% vs. 38%
Previous ulcer bleeding: 30% vs. 30%
Recent use of H2 antagonist or PPI: 2% vs. 2%
Risk factor of bleeding peptic ulcer:

H.pylori infection: 65% vs. 53%

Use of NSAIDs: 33% vs. 33%

Use of aspirin: 19% vs. 15%

Use of warfarin: 4% vs. 4%

Development of bleeding during hospitalization: 18% vs. 19%
Pts with coexisting illnesses: 25% vs. 30%

Inclusion Criteria

• >16 years
• Patients with successful endoscopic treatment of actively bleeding ulcers or ulcers with nonbleeding visible vessels

Exclusion Criteria

• Unsuccessful endoscopic treatment

Interventions

• After endoscopic treatment, patients were randomly assigned to receive an intravenous infusion of placebo or omeprazole, given as an 80-mg bolus injection followed by a continuous infusion of 8 mg per hour for a period of 72 hours.
  • Identical-appearing vials of omeprazole and placebo were prepared with random numbers in blocks of 80
  • Treatment was started in the recovery area of the endoscopy suite and continued in a surgical ward.

Outcomes

Primary Outcome

• Bleeding recurred within 30 days after treatment in 8 patients (6.7%) in omeprazole group, as compared with 27 (22.5%) in the placebo group.
• Hazard ratio: 3.9 (95% CI 1.7-9.0)
• Recurrent bleeding most common in first 3 days: 4.2% in omeprazole vs. 20% in placebo