Clinical trial: intravenous pantoprazole vs. ranitidine for the prevention of peptic ulcer rebleeding: a multicentre, multinational, randomized trial
| Autor: | Richard N. Fedorak, C. J. Van Rensburg, R Luehmann, Jacques Devière, H. Doerfler, P C Bornman, J Balanzó, Alan N. Barkun, S Schäfer-Preuss, Limas Kupčinskas, István Rácz, Christoph Beglinger |
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| Rok vydání: | 2009 |
| Předmět: |
Adult
medicine.medical_specialty Adolescent medicine.drug_class Statistics as Topic Proton-pump inhibitor Peptic Ulcer Hemorrhage Ranitidine Placebo Gastroenterology 2-Pyridinylmethylsulfinylbenzimidazoles Efficacy Young Adult Double-Blind Method Internal medicine Injection site reaction Secondary Prevention medicine Clinical endpoint Humans Pharmacology (medical) Pantoprazole Aged Hepatology business.industry Middle Aged Anti-Ulcer Agents medicine.disease Injections Intravenous business medicine.drug |
| Zdroj: | Alimentary Pharmacology & Therapeutics. 29:497-507 |
| ISSN: | 1365-2036 0269-2813 |
| DOI: | 10.1111/j.1365-2036.2008.03904.x |
| Popis: | 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+13 mg/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. |
| Databáze: | OpenAIRE |
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