Single-dose aprepitant vs ondansetron for the prevention of postoperative nausea and vomiting: a randomized, double-blind Phase III trial in patients undergoing open abdominal surgery

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dc.contributor.authorDiemunsch, P.
dc.contributor.authorGan, T. J.
dc.contributor.authorPhilip, E. K.
dc.contributor.authorGirão, Manoel João Batista Castello [UNIFESP]
dc.contributor.authorEherharts, L.
dc.contributor.authorIrwin, M. G.
dc.contributor.authorPueyo, J.
dc.contributor.authorChelly, J. E.
dc.contributor.authorCarides, A. I.
dc.contributor.authorReiss, T.
dc.contributor.authorEvans, J. K.
dc.contributor.authorLawson, F. C.
dc.contributor.authorAprepitant PONV Protocol 091 Study
dc.contributor.institutionCHU Strasbourg
dc.contributor.institutionDuke Univ
dc.contributor.institutionBrigham & Womens Hosp
dc.contributor.institutionUniversidade Federal de São Paulo (UNIFESP)
dc.contributor.institutionUniv Marburg
dc.contributor.institutionUniv Hong Kong
dc.contributor.institutionUniv Navarra Clin
dc.contributor.institutionUniv Pittsburgh
dc.contributor.institutionMerck Res Labs
dc.date.accessioned2016-01-24T13:48:53Z
dc.date.available2016-01-24T13:48:53Z
dc.date.issued2007-08-01
dc.description.abstractBackground. the neurokinin(l) antagonist aprepitant is effective for prevention of chemotherapy-induced nausea and vomiting. We compared aprepitant with ondansetron for prevention of postoperative nausea and vomiting.Methods. Nine hundred and twenty-two patients receiving general anaesthesia for major abdominal surgery were assigned to receive a single preoperative dose of oral aprepitant 40 mg, oral aprepitant 125 mg, or i.v. ondansetron 4 mg in a randomized, double-blind trial. Vomiting episodes, use of rescue therapy, and nausea severity (verbal rating scale) were documented for 48 h after surgery. Primary efficacy endpoints were complete response (no vomiting and no use of rescue therapy) 0-24 h after surgery and no vomiting 0-24 h after surgery. the secondary endpoint was no vomiting 0-48 h after surgery.Results. Aprepitant at both doses was non-inferior to ondansetron for complete response 0-24 h after surgery (64% for aprepitant 40 mg, 63% for aprepitant 125 mg, and 55% for ondansetron, lower bound of 1-sided 95% CI > 0.65), superior to ondansetron for no vomiting 0-24 h after surgery (84% for aprepitant 40 mg, 86% for aprepitant 125 mg, and 71 % for ondansetron; P < 0.001), and superior for no vomiting 0-48 h after surgery (82% for aprepitant, 40 mg, 85% for aprepitant, 125 mg, and 66% for ondansetron; P < 0.001). the distribution of peak nausea scores was lower in both aprepitant groups vs ondansetron (P < 0.05).Conclusions. Aprepitant was non-inferior to ondansetron in achieving complete response for 24 h after surgery. Aprepitant was significantly more effective than ondansetron for preventing vomiting at 24 and 48 h after surgery, and in reducing nausea severity in the first 48 h after surgery. Aprepitant was generally well tolerated.en
dc.description.affiliationCHU Strasbourg, Hop Hautepierre, Serv Anesthesiol Reanimat Chirurg, F-67000 Strasbourg, France
dc.description.affiliationDuke Univ, Med Ctr, Dept Anesthesiol, Durham, NC 27710 USA
dc.description.affiliationBrigham & Womens Hosp, Dept Anesthesiol Perioperat & Pain Med, Boston, MA 02115 USA
dc.description.affiliationUniversidade Federal de São Paulo, São Paulo, Brazil
dc.description.affiliationUniv Marburg, Abt Anaesthesie & Intens Therapie, Marburg, Germany
dc.description.affiliationUniv Hong Kong, Dept Anaesthesiol, Hong Kong, Hong Kong, Peoples R China
dc.description.affiliationUniv Navarra Clin, Navarra 31008, Spain
dc.description.affiliationUniv Pittsburgh, Med Ctr, Dept Anesthesiol, Pittsburgh, PA 15232 USA
dc.description.affiliationMerck Res Labs, West Point, PA 19486 USA
dc.description.affiliationUnifespUniversidade Federal de São Paulo, São Paulo, Brazil
dc.description.sourceWeb of Science
dc.format.extent202-211
dc.identifierhttp://dx.doi.org/10.1093/bja/aem133
dc.identifier.citationBritish Journal of Anaesthesia. Oxford: Oxford Univ Press, v. 99, n. 2, p. 202-211, 2007.
dc.identifier.doi10.1093/bja/aem133
dc.identifier.issn0007-0912
dc.identifier.urihttp://repositorio.unifesp.br/handle/11600/29881
dc.identifier.wosWOS:000248683000009
dc.language.isoeng
dc.publisherOxford Univ Press
dc.relation.ispartofBritish Journal of Anaesthesia
dc.rightsinfo:eu-repo/semantics/openAccess
dc.rights.licensehttp://www.oxfordjournals.org/access_purchase/self-archiving_policyb.html
dc.subjectaprepitanten
dc.subjectclinical trialsen
dc.subjectPONVen
dc.subjectondansetronen
dc.subjectserotonin (5-hydroxy-tryptamine), antagonismen
dc.titleSingle-dose aprepitant vs ondansetron for the prevention of postoperative nausea and vomiting: a randomized, double-blind Phase III trial in patients undergoing open abdominal surgeryen
dc.typeinfo:eu-repo/semantics/article
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