Publication: Casopitant and ondansetron for postoperative nausea and vomiting prevention in women at high risk for emesis: A phase 3 study
Issued Date
2011-02-01
Resource Type
ISSN
15383644
00040010
00040010
Other identifier(s)
2-s2.0-79951929249
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Mahidol University
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SCOPUS
Bibliographic Citation
Archives of Surgery. Vol.146, No.2 (2011), 201-206
Suggested Citation
Áron Altorjay, Timothy Melson, Thitima Chinachoit, Attila Kett, Keith Aqua, Jeremey Levin, Linda M. Blackburn, Steve Lane, Joseph V. Pergolizzi Casopitant and ondansetron for postoperative nausea and vomiting prevention in women at high risk for emesis: A phase 3 study. Archives of Surgery. Vol.146, No.2 (2011), 201-206. doi:10.1001/archsurg.2010.327 Retrieved from: https://repository.li.mahidol.ac.th/handle/123456789/12696
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Title
Casopitant and ondansetron for postoperative nausea and vomiting prevention in women at high risk for emesis: A phase 3 study
Abstract
Hypothesis: Postoperative nausea and vomiting (PONV) are associated with a variety of complications. Neurokinin subtype 1 receptor antagonists have antiemetic activity in the postoperative setting, and the neurokinin subtype 1 receptor antagonist casopitant mesylate (GW679769) was well tolerated and effective at reducing the incidence of PONV in phase 1 and phase 2 trials. Design: A multicenter, randomized, double-blind, parallel-group, phase 3 analysis was designed to evaluate the safety and efficacy of casopitant in combination with a single intravenous dose of the serotonin subtype 3 receptor antagonist ondansetron hydrochloride for the prevention of PONV in the perioperative setting. Setting: Forty-three centers in 11 countries. Patients: We studied 484 women at high risk for developing PONV scheduled to undergo operations associated with high emetogenic risk. Interventions: The women were randomized to receive a single dose of intravenous ondansetron, 4 mg, or oral casopitant, 50 mg, in combination with intravenous ondansetron, 4 mg. Main Outcome Measures: The primary end point was the proportion of patients who achieved a complete response, defined as no vomiting, retching, or rescue therapy. Patients received a balanced anesthetic regimen. Results: Between March 20 and August 31, 2006, 484 patients were enrolled in the study. Patients in the casopitant plus ondansetron group had a 68.7% rate of complete response during the first 24 hours after surgery compared with 58.7% in the ondansetron -only group (P=.03). The difference between groups in complete response from 24 to 48 hours (63.4% with ondansetron only vs 70.0% with ondansetron plus casopitant) was not significant. No vomiting for 0 to 24 hours was observed in 89.7% of the casopitant plus ondansetron group compared with 74.9% of the ondansetron-only group (P < .001). Oral casopitant administered in combination with ondansetron was well tolerated. Conclusions: The results of this pivotal phase 3 study demonstrate that the combination of casopitant and ondansetron was superior to ondansetron only in patients at high risk for PONV. Trial Registration: clinicaltrials.gov Identifier: NCT00326248. ©2011 American Medical Association. All rights reserved.