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. doi: 10.1056/NEJM200008033430501.

Abstract

Background: After endoscopic treatment of bleeding peptic ulcers, bleeding recurs in 15 to 20 percent of patients.

Methods: We assessed whether the use of a high dose of a proton-pump inhibitor would reduce the frequency of recurrent bleeding after endoscopic treatment of bleeding peptic ulcers. Patients with actively bleeding ulcers or ulcers with nonbleeding visible vessels were treated with an epinephrine injection followed by thermocoagulation. After hemostasis had been achieved, they were randomly assigned in a double-blind fashion to receive omeprazole (given as a bolus intravenous injection of 80 mg followed by an infusion of 8 mg per hour for 72 hours) or placebo. After the infusion, all patients were given 20 mg of omeprazole orally per day for eight weeks. The primary end point was recurrent bleeding within 30 days after endoscopy.

Results: We enrolled 240 patients, 120 in each group. Bleeding recurred within 30 days in 8 patients (6.7 percent) in the omeprazole group, as compared with 27 (22.5 percent) in the placebo group (hazard ratio, 3.9; 95 percent confidence interval, 1.7 to 9.0). Most episodes of recurrent bleeding occurred during the first three days, which made up the infusion period (5 in the omeprazole group and 24 in the placebo group, P<0.001). Three patients in the omeprazole group and nine in the placebo group underwent surgery (P=0.14). Five patients (4.2 percent) in the omeprazole group and 12 (10 percent) in the placebo group died within 30 days after endoscopy (P=0.13).

Conclusions: After endoscopic treatment of bleeding peptic ulcers, a high-dose infusion of omeprazole substantially reduces the risk of recurrent bleeding.

Publication types

  • Clinical Trial
  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Anti-Ulcer Agents / administration & dosage
  • Anti-Ulcer Agents / therapeutic use*
  • Combined Modality Therapy
  • Double-Blind Method
  • Electrocoagulation
  • Endoscopy, Gastrointestinal
  • Epinephrine / therapeutic use
  • Female
  • Humans
  • Injections, Intravenous
  • Length of Stay
  • Male
  • Middle Aged
  • Omeprazole / administration & dosage
  • Omeprazole / therapeutic use*
  • Peptic Ulcer / drug therapy*
  • Peptic Ulcer / mortality
  • Peptic Ulcer / surgery
  • Peptic Ulcer Hemorrhage / drug therapy*
  • Peptic Ulcer Hemorrhage / mortality
  • Peptic Ulcer Hemorrhage / prevention & control
  • Peptic Ulcer Hemorrhage / surgery
  • Proton Pump Inhibitors*
  • Risk
  • Secondary Prevention
  • Vasoconstrictor Agents / therapeutic use

Substances

  • Anti-Ulcer Agents
  • Proton Pump Inhibitors
  • Vasoconstrictor Agents
  • Omeprazole
  • Epinephrine