A randomized, double-blind comparison of the NK1 antagonist, aprepitant, versus ondansetron for the prevention of postoperative nausea and vomiting.
BACKGROUND
Antiemetics currently in use are not totally effective. Neurokinin-1 receptor antagonists are a new class of antiemetic that have shown promise for chemotherapy-induced nausea and vomiting. This is the first study evaluating the efficacy and tolerability of the neurokinin-1 receptor antagonist, aprepitant, for the prevention of postoperative nausea and vomiting.


METHODS
In this multicenter, double-blind trial, we randomly assigned 805 patients receiving general anesthesia for open abdominal surgery to a preoperative dose of aprepitant 40 mg orally, aprepitant 125 mg orally, or ondansetron 4 mg IV. Vomiting, nausea, and use of rescue therapy were assessed over 48 h after surgery. Treatments were compared using logistic regression.


RESULTS
Incidence rates for the primary end point (complete response [no vomiting and no use of rescue] over 0-24 h after surgery, tested for superiority of aprepitant) were not different across groups (45% with aprepitant 40 mg, 43% with aprepitant 125 mg, and 42% with ondansetron). The incidence of no vomiting (0-24 h) was higher with aprepitant 40 mg (90%) and aprepitant 125 mg (95%) versus ondansetron (74%) (P < 0.001 for both comparisons), although between-treatment use of rescue and nausea control was not different. Both aprepitant doses also had higher incidences of no vomiting over 0-48 h (P < 0.001). No statistically significant differences were seen among the side effect profiles of the treatments.


CONCLUSIONS
Aprepitant was superior to ondansetron for prevention of vomiting in the first 24 and 48 h, but no significant differences were observed between aprepitant and ondansetron for nausea control, use of rescue, or complete response.
Gan
Tong J
TJ
Department of Anesthesiology, Duke University Medical Centre, Durham, North Carolina 27710, USA. gan00001@mc.duke.edu
Apfel
Christian C
CC
Kovac
Anthony
A
Philip
Beverly K
BK
Singla
Neil
N
Minkowitz
Harold
H
Habib
Ashraf S
AS
Knighton
Jennifer
J
Carides
Alexandra D
AD
Zhang
Hong
H
Horgan
Kevin J
KJ
Evans
Judith K
JK
Lawson
Francasca C
FC
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000077608:Aprepitant; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009025:Morpholines / Q000494:pharmacology / Q000627:therapeutic use*; D064729:Neurokinin-1 Receptor Antagonists; D017294:Ondansetron / Q000494:pharmacology / Q000627:therapeutic use*; D020250:Postoperative Nausea and Vomiting / Q000188:drug therapy* / Q000453:epidemiology / Q000503:physiopathology; D018040:Receptors, Neurokinin-1 / Q000502:physiology
D009025:Morpholines; D064729:Neurokinin-1 Receptor Antagonists; D018040:Receptors, Neurokinin-1; D000077608:Aprepitant; D017294:Ondansetron