Clinical trial: Intravenous pantoprazole vs. ranitidine for the prevention of peptic ulcer rebleeding: A multicentre, multinational, randomized trial
Date
2009
Authors
Van Rensburg C.
Barkun A.N.
Racz I.
Fedorak R.
Bornman P.C.
Beglinger C.
Balanzo J.
Deviere J.
Kupcinskas L.
Luehmann R.
Journal Title
Journal ISSN
Volume Title
Publisher
Abstract
Background: Controlled pantoprazole data in peptic ulcer bleeding are few. Aim: To compare intravenous (IV) pantoprazole with IV ranitidine for bleeding ulcers. Methods: After endoscopic haemostasis, 1256 patients were randomized to pantoprazole 80 mg+8 mg/h or ranitidine 50 mg+13mg/h, both for 72 h. Patients underwent second-look endoscopy on day 3 or earlier, if clinically indicated. The primary endpoint was an overall outcome ordinal score: no rebleeding, rebleeding without/with subsequent haemostasis, surgery and mortality. The latter three events were also assessed separately and together. Results: There were no between-group differences in overall outcome scores (pantoprazole vs. ranitidine: S0: 91.2 vs. 89.3%, S1: 1.5 vs. 2.5%, S2: 5.4 vs. 5.7%, S3: 1.7 vs. 2.1%, S4: 0.19 vs. 0.38%, P = 0.083), 72-h clinically detected rebleeding (2.9% [95% CI 1.7, 4.6] vs. 3.2% [95% CI 2.0, 4.9]), surgery (1.9% [95% CI 1.0, 3.4] vs. 2.1% [95% CI 1.1, 3.5]) or day-3 mortality (0.2% [95% CI 0, 0.09] vs. 0.3% [95% CI 0, 1.1]). Pantoprazole significantly decreased cumulative frequencies of events comprising the ordinal score in spurting lesions (13.9% [95% CI 6.6, 24.7] vs. 33.9% [95% CI 22.1, 47.4]; P = 0.01) and gastric ulcers (6.7% [95% CI 4, 10.4] vs. 14.3% [95% CI 10.3, 19.2], P = 0.006). Conclusions: Outcomes amongst pantoprazole and ranitidine-treated patients were similar; pantoprazole provided benefits in patients with arterial spurting and gastric ulcers. © 2009 Blackwell Publishing Ltd.
Description
Keywords
acetylsalicylic acid, adrenalin, nonsteroid antiinflammatory agent, pantoprazole, placebo, ranitidine, adult, aged, anticoagulation, article, clinical trial, confidence interval, continuous infusion, controlled clinical trial, controlled study, double blind procedure, drug efficacy, drug safety, endoscopy, female, gastrointestinal surgery, hemostasis, human, injection site reaction, major clinical study, male, mortality, multicenter study, outcome assessment, peptic ulcer bleeding, priority journal, randomized controlled trial, statistical analysis, stomach ulcer, thermocoagulation, thrombophlebitis, treatment outcome, 2-Pyridinylmethylsulfinylbenzimidazoles, Adolescent, Adult, Aged, Anti-Ulcer Agents, Double-Blind Method, Humans, Injections, Intravenous, Middle Aged, Peptic Ulcer Hemorrhage, Ranitidine, Recurrence, Statistics as Topic, Young Adult
Citation
Alimentary Pharmacology and Therapeutics
29
5
29
5