Preventing postoperative nausea and vomiting: post hoc analysis of pooled data from two randomized active-controlled trials of aprepitant.
OBJECTIVE
Compared with the 5HT(3) antagonist ondansetron, the NK(1) antagonist aprepitant has been shown in two double-blind trials to provide greater protection against postoperative vomiting and comparable or greater control of nausea. Post hoc analyses of pooled data from these trials were performed to more fully characterize the efficacy profile of aprepitant in terms of nausea and use of rescue therapy.


METHODS
Patients (n = 1599) scheduled for major surgery under general anesthesia (primarily gynecological surgery) were assigned to receive a preoperative dose of aprepitant 40 mg PO, 125 mg PO, or ondansetron 4 mg IV. in two randomized, double-blind, clinical trials.


METHODS
Post-surgery vomiting episodes, use of rescue therapy, and nausea severity (verbal rating scale).


RESULTS
In the 24 hours after surgery, aprepitant 40 mg was more effective than ondansetron for all five endpoints evaluated: (1) no significant nausea (56.4% vs. 48.1%); (2) no nausea (39.6% vs. 33.1%); (3) no vomiting (86.7% vs. 72.4%); (4) no nausea and no vomiting (38.3% vs. 31.4%); and (5) no nausea, no vomiting, and no use of rescue (37.9% vs. 31.2%) (p < 0.035 for the odds ratio for each comparison). Numerically more patients receiving aprepitant 125 mg also achieved these endpoints compared with ondansetron.


CONCLUSIONS
These post hoc analyses confirm the favorable efficacy profile of aprepitant for the prevention of post operative nausea and vomiting.
Diemunsch
Pierre
P
Hôpital de Hautepierre, Strasbourg, France. pierre.diemunsch@chru-strasbourg.fr
Apfel
Christian
C
Gan
Tong J
TJ
Candiotti
Keith
K
Philip
Beverly K
BK
Chelly
Jacques
J
Carides
Alexandra D
AD
Evans
Judith K
JK
Ho
Tony W
TW
Reiss
Theodore
T
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000932:Antiemetics / Q000627:therapeutic use*; D000077608:Aprepitant; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009025:Morpholines / Q000627:therapeutic use*; D020250:Postoperative Nausea and Vomiting / Q000517:prevention & control*; D016896:Treatment Outcome
D000932:Antiemetics; D009025:Morpholines; D000077608:Aprepitant