Randomised clinical trial: high-dose vs. standard-dose proton pump inhibitors for the prevention of recurrent haemorrhage after combined endoscopic haemostasis of bleeding peptic ulcers

Aliment Pharmacol Ther. 2012 Apr;35(8):894-903. doi: 10.1111/j.1365-2036.2012.05047.x. Epub 2012 Feb 28.

Abstract

Background: The optimal dosage of intravenous proton pump inhibitors (PPIs) for the prevention of peptic ulcer rebleeding remains unclear.

Aim: To compare the rebleeding rate of high-dose and standard-dose PPI use after endoscopic haemostasis.

Methods: A total of 201 patients with bleeding ulcers undergoing endoscopic treatment with epinephrine injection and heater probe thermocoagulation were randomised to receive a high-dose regimen (80 mg bolus, followed by pantoprazole 8 mg/h infusion, n = 100) or a standard-dose regimen (pantoprazole 40 mg bolus daily, n = 101). After 72 h, all patients were given 40 mg pantoprazole daily orally for 27 days.

Results: There were no statistical differences in mean units of blood transfused, length of hospitalisation ≦5 days, surgical or radiological interventions and mortality within 30 days between two groups. Bleeding recurred within 30 days in six patients [6.2%, 95% confidence interval (CI) 1.3-11.1%] in the high-dose group, as compared to five patients (5.2%, 95% CI 0.6-9.7%) in the standard-dose group (P = 0.77). The stepwise Cox regression analysis showed end-stage renal disease, haematemesis, chronic obstructive pulmonary disease (hazard ratio: 37.15, 10.07, 9.12, 95% CI: 6.76-204.14, 2.07-49.01, 1.66-50.00 respectively) were independent risk factors for rebleeding and Helicobacter pylori infection was associated with lower risk of rebleeding (hazard ratio: 0.20, 95% CI: 0.04-0.94).

Conclusions: Following combined endoscopic haemostasis of bleeding ulcers, co-morbidities, haematemesis and H. pylori Status, but not PPI dosage, are associated with rebleeding (http://www.Clinical Trials.gov.ID: NCT00709046).

Publication types

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

MeSH terms

  • 2-Pyridinylmethylsulfinylbenzimidazoles / administration & dosage*
  • Aged
  • Aged, 80 and over
  • Dose-Response Relationship, Drug
  • Electrocoagulation / methods
  • Epinephrine / therapeutic use
  • Female
  • Helicobacter Infections / complications
  • Helicobacter pylori / isolation & purification
  • Hemostasis, Endoscopic / methods*
  • Humans
  • Male
  • Middle Aged
  • Pantoprazole
  • Peptic Ulcer Hemorrhage / prevention & control*
  • Peptic Ulcer Hemorrhage / therapy
  • Prospective Studies
  • Proton Pump Inhibitors / administration & dosage*
  • Regression Analysis
  • Risk Factors
  • Secondary Prevention
  • Vasoconstrictor Agents / therapeutic use*

Substances

  • 2-Pyridinylmethylsulfinylbenzimidazoles
  • Proton Pump Inhibitors
  • Vasoconstrictor Agents
  • Pantoprazole
  • Epinephrine

Associated data

  • ClinicalTrials.gov/NCT00709046