TY - JOUR
T1 - Casopitant and ondansetron for postoperative nausea and vomiting prevention in women at high risk for emesis
T2 - A phase 3 study
AU - Altorjay, Áron
AU - Melson, Timothy
AU - Chinachoit, Thitima
AU - Kett, Attila
AU - Aqua, Keith
AU - Levin, Jeremey
AU - Blackburn, Linda M.
AU - Lane, Steve
AU - Pergolizzi, Joseph V.
PY - 2011/2
Y1 - 2011/2
N2 - 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
AB - 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
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U2 - 10.1001/archsurg.2010.327
DO - 10.1001/archsurg.2010.327
M3 - Article
C2 - 21339433
AN - SCOPUS:79951929249
SN - 0004-0010
VL - 146
SP - 201
EP - 206
JO - Archives of Surgery
JF - Archives of Surgery
IS - 2
ER -