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Article: 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

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 surgery
Authors
KeywordsAntagonism
Aprepitant
Clinical trials
Ondansetron
PONV
Serotonin (5-hydroxy-tryptamine)
Issue Date2007
PublisherOxford University Press. The Journal's web site is located at http://bja.oxfordjournals.org/
Citation
British Journal Of Anaesthesia, 2007, v. 99 n. 2, p. 202-211 How to Cite?
AbstractBackground: The neurokinin1 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. © The Board of Management and Trustees of the British Journal of Anaesthesia 2007. All rights reserved.
Persistent Identifierhttp://hdl.handle.net/10722/145546
ISSN
2015 Impact Factor: 5.616
2015 SCImago Journal Rankings: 2.314
ISI Accession Number ID
References

 

DC FieldValueLanguage
dc.contributor.authorDiemunsch, Pen_HK
dc.contributor.authorGan, TJen_HK
dc.contributor.authorPhilip, BKen_HK
dc.contributor.authorGirao, MJen_HK
dc.contributor.authorEberhart, Len_HK
dc.contributor.authorIrwin, MGen_HK
dc.contributor.authorPueyo, Jen_HK
dc.contributor.authorChelly, JEen_HK
dc.contributor.authorCarides, ADen_HK
dc.contributor.authorReiss, Ten_HK
dc.contributor.authorEvans, JKen_HK
dc.contributor.authorLawson, FCen_HK
dc.contributor.authorAprepitant-PONV Protocol 091 International Study Group-
dc.date.accessioned2012-02-28T01:53:19Z-
dc.date.available2012-02-28T01:53:19Z-
dc.date.issued2007en_HK
dc.identifier.citationBritish Journal Of Anaesthesia, 2007, v. 99 n. 2, p. 202-211en_HK
dc.identifier.issn0007-0912en_HK
dc.identifier.urihttp://hdl.handle.net/10722/145546-
dc.description.abstractBackground: The neurokinin1 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. © The Board of Management and Trustees of the British Journal of Anaesthesia 2007. All rights reserved.en_HK
dc.languageengen_US
dc.publisherOxford University Press. The Journal's web site is located at http://bja.oxfordjournals.org/en_HK
dc.relation.ispartofBritish Journal of Anaesthesiaen_HK
dc.subjectAntagonismen_HK
dc.subjectAprepitanten_HK
dc.subjectClinical trialsen_HK
dc.subjectOndansetronen_HK
dc.subjectPONVen_HK
dc.subjectSerotonin (5-hydroxy-tryptamine)en_HK
dc.subject.meshAbdomen - surgery-
dc.subject.meshAntiemetics - administration and dosage - therapeutic use-
dc.subject.meshMorpholines - administration and dosage - therapeutic use-
dc.subject.meshOndansetron - therapeutic use-
dc.subject.meshPostoperative Nausea and Vomiting - prevention and control-
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_HK
dc.typeArticleen_HK
dc.identifier.emailIrwin, MG:mgirwin@hku.hken_HK
dc.identifier.authorityIrwin, MG=rp00390en_HK
dc.description.naturelink_to_OA_fulltext-
dc.identifier.doi10.1093/bja/aem133en_HK
dc.identifier.pmid17540667-
dc.identifier.scopuseid_2-s2.0-34547866543en_HK
dc.identifier.hkuros134903en_US
dc.relation.referenceshttp://www.scopus.com/mlt/select.url?eid=2-s2.0-34547866543&selection=ref&src=s&origin=recordpageen_HK
dc.identifier.volume99en_HK
dc.identifier.issue2en_HK
dc.identifier.spage202en_HK
dc.identifier.epage211en_HK
dc.identifier.isiWOS:000248683000009-
dc.publisher.placeUnited Kingdomen_HK

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