Clinical trial: Intravenous pantoprazole vs. ranitidine for the prevention of peptic ulcer rebleeding: A multicentre, multinational, randomized trial

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dc.contributor.authorVan Rensburg C.
dc.contributor.authorBarkun A.N.
dc.contributor.authorRacz I.
dc.contributor.authorFedorak R.
dc.contributor.authorBornman P.C.
dc.contributor.authorBeglinger C.
dc.contributor.authorBalanzo J.
dc.contributor.authorDeviere J.
dc.contributor.authorKupcinskas L.
dc.contributor.authorLuehmann R.
dc.contributor.authorDoerfler H.
dc.contributor.authorSchafer-Preuss S.
dc.date.accessioned2011-05-15T16:15:17Z
dc.date.available2011-05-15T16:15:17Z
dc.date.issued2009
dc.description.abstractBackground: 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.
dc.description.versionArticle
dc.identifier.citationAlimentary Pharmacology and Therapeutics
dc.identifier.citation29
dc.identifier.citation5
dc.identifier.issn02692813
dc.identifier.other10.1111/j.1365-2036.2008.03904.x
dc.identifier.urihttp://hdl.handle.net/10019.1/13272
dc.subjectacetylsalicylic acid
dc.subjectadrenalin
dc.subjectnonsteroid antiinflammatory agent
dc.subjectpantoprazole
dc.subjectplacebo
dc.subjectranitidine
dc.subjectadult
dc.subjectaged
dc.subjectanticoagulation
dc.subjectarticle
dc.subjectclinical trial
dc.subjectconfidence interval
dc.subjectcontinuous infusion
dc.subjectcontrolled clinical trial
dc.subjectcontrolled study
dc.subjectdouble blind procedure
dc.subjectdrug efficacy
dc.subjectdrug safety
dc.subjectendoscopy
dc.subjectfemale
dc.subjectgastrointestinal surgery
dc.subjecthemostasis
dc.subjecthuman
dc.subjectinjection site reaction
dc.subjectmajor clinical study
dc.subjectmale
dc.subjectmortality
dc.subjectmulticenter study
dc.subjectoutcome assessment
dc.subjectpeptic ulcer bleeding
dc.subjectpriority journal
dc.subjectrandomized controlled trial
dc.subjectstatistical analysis
dc.subjectstomach ulcer
dc.subjectthermocoagulation
dc.subjectthrombophlebitis
dc.subjecttreatment outcome
dc.subject2-Pyridinylmethylsulfinylbenzimidazoles
dc.subjectAdolescent
dc.subjectAdult
dc.subjectAged
dc.subjectAnti-Ulcer Agents
dc.subjectDouble-Blind Method
dc.subjectHumans
dc.subjectInjections, Intravenous
dc.subjectMiddle Aged
dc.subjectPeptic Ulcer Hemorrhage
dc.subjectRanitidine
dc.subjectRecurrence
dc.subjectStatistics as Topic
dc.subjectYoung Adult
dc.titleClinical trial: Intravenous pantoprazole vs. ranitidine for the prevention of peptic ulcer rebleeding: A multicentre, multinational, randomized trial
dc.typeArticle
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