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  • Omeprazole in Peptic Ulcer Bleeding Original

    • Omeprazole in Peptic Ulcer Bleeding

    "High-Dose Proton-Pump Inhibitor for Peptic Ulcer Hemorrhage".The New England Journal of Medicine. 2000. 343(5):310-316.PubMed•Full text•PDF

    Contents



    1. Clinical Question
    2. Bottom Line
    3. Major Points
    4. Guidelines
    5. Design
    6. Population
    6.1 Inclusion Criteria
    6.2 Exclusion Criteria
    6.3 Baseline Characteristics
    7. Interventions
    8. Outcomes
    8.1 Primary Outcomes
    8.2 Secondary Outcomes
    9. Funding
    10. Further Reading

    Clinical Question


    Does the use of high-dose intravenous omeprazole after endoscopic treatment for bleeding peptic ulcers reduce the rate of recurrent bleeding?

    Bottom Line


    The use of high-dose intravenous omeprazole following successful endoscopic treatment for bleeding peptic ulcers significantly reduces the risk of recurrent bleeding within the next 30 days.

    Major Points


    Bleeding peptic ulcers have a high rate of recurrence despite successful endoscopic treatment, and subsequent bleeding is associated with a high mortality rate. Stabilization of blood clots within the ulcer may be facilitated by neutral gastric pH, which can be achieved using a proton-pump inhibitor (PPI).

    Guidelines


    Contemporary guidelines for the management of peptic ulcer bleeding recommend the use of PPIs but may not specify the dosing strategy.

    Design


    - Multicenter, double-blind, parallel-group, randomized, placebo-controlled trial.
    - N=240 patients with bleeding peptic ulcers.
    - High-dose omeprazole (intravenous bolus of 80 mg followed by an infusion of 8 mg per hour for 72 hours) vs. placebo.
    - After the infusion, all patients were given 20 mg of oral omeprazole per day for eight weeks.
    - Enrollment: May 1998 to July 1999.
    - Follow-up: 30 days post-endoscopy, with outpatients reevaluated at eight weeks.

    Population


    Inclusion Criteria:
    - Patients aged 16 and older.
    - Successful endoscopic treatment of actively bleeding ulcers or ulcers with nonbleeding visible vessels (after stabilization if in shock or vomiting fresh blood).

    Exclusion Criteria:
    - Failed endoscopic treatment requiring immediate surgery.
    - Patients with terminal cancer, moribund due to concomitant illness, or who did not provide consent.

    Baseline Characteristics:
    - Patients were similar in demographics, types of coexisting illnesses, severity of bleeding, risk factors for ulcers, and other relevant factors with no significant differences between groups.

    Interventions


    - Intravenous infusion of placebo or omeprazole (80 mg bolus followed by 8 mg per hour for 72 hours).
    - Followed by 20 mg of oral omeprazole per day for eight weeks.
    - Patients with H. pylori received an additional combination therapy for eradication.

    Outcomes


    Primary Outcomes:
    - Recurrent bleeding within 30 days after endoscopy.
    - Recurrence rate: 6.7% in the omeprazole group vs. 22.5% in the placebo group (hazard ratio, 3.9; 95% CI, 1.7 to 9.0).

    Secondary Outcomes:
    - Significantly fewer surgical interventions and a shorter hospital stay were observed in the omeprazole group.
    - Reduction in rates of retreatment and blood transfusions were seen with omeprazole.
    - Deaths within 30 days after endoscopy were not statistically different (4.2% in the omeprazole group vs. 10% in the placebo group; P=0.13).

    Funding


    Supported in full by a grant from the Research Grants Council of the Hong Kong Special Administration Region.

    Further Reading


    For additional information and context, further reading includes comprehensive guidelines on the management of peptic ulcer bleeding, as well as other related clinical trials and meta-analyses exploring the benefits of proton-pump inhibitors in this patient population.