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
Journal
Alimentary Pharmacology and Therapeutics
Journal Volume
35
Journal Issue
8
Pages
894-903
Date Issued
2012
Author(s)
Lee J.-Y.
Hu F.-C.
Lin T.-L.
Lin J.-T.
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 (.ID: NCT00709046). ? 2012 Blackwell Publishing Ltd.
SDGs
Other Subjects
adrenalin; amoxicillin; clarithromycin; pantoprazole; adult; aged; article; blood transfusion; chronic obstructive lung disease; comorbidity; continuous infusion; controlled study; disease association; dose response; drug dose comparison; drug efficacy; drug megadose; endoscopic hemostasis; female; gastrointestinal hemorrhage; Helicobacter infection; hematemesis; hemostasis; hospitalization; human; intervention study; kidney failure; length of stay; major clinical study; male; melena; mortality; outcome assessment; peptic ulcer; priority journal; randomized controlled trial; recurrent disease; risk factor; thermoregulation; 2-Pyridinylmethylsulfinylbenzimidazoles; Aged; Aged, 80 and over; Dose-Response Relationship, Drug; Electrocoagulation; Epinephrine; Female; Helicobacter Infections; Helicobacter pylori; Hemostasis, Endoscopic; Humans; Male; Middle Aged; Peptic Ulcer Hemorrhage; Prospective Studies; Proton Pump Inhibitors; Recurrence; Regression Analysis; Risk Factors; Vasoconstrictor Agents
Type
journal article