title: 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.
abstract: BACKGROUND
  The neurokinin(1) 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.
authors.affiliation: Services d'Anesthesiologie-Reanimation Chirurgicale, CHU, Hôpital de Hautepierre, 1 Avenue de Moliere, Strasbourg 67000, France. pierre.diemunsch@chru-strasbourg.fr
authors.forename: P
authors.initials: P
authors.lastname: Diemunsch
authors.forename: T J
authors.initials: TJ
authors.lastname: Gan
authors.forename: B K
authors.initials: BK
authors.lastname: Philip
authors.forename: M J
authors.initials: MJ
authors.lastname: Girao
authors.forename: L
authors.initials: L
authors.lastname: Eberhart
authors.forename: M G
authors.initials: MG
authors.lastname: Irwin
authors.forename: J
authors.initials: J
authors.lastname: Pueyo
authors.forename: J E
authors.initials: JE
authors.lastname: Chelly
authors.forename: A D
authors.initials: AD
authors.lastname: Carides
authors.forename: T
authors.initials: T
authors.lastname: Reiss
authors.forename: J K
authors.initials: JK
authors.lastname: Evans
authors.forename: F C
authors.initials: FC
authors.lastname: Lawson
mesh_terms: D000005:Abdomen / Q000601:surgery*; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000932:Antiemetics / Q000008:administration & dosage / Q000627:therapeutic use*; D000077608:Aprepitant; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009025:Morpholines / Q000008:administration & dosage / Q000627:therapeutic use*; D017294:Ondansetron / Q000627:therapeutic use*; D020250:Postoperative Nausea and Vomiting / Q000517:prevention & control*; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D000932:Antiemetics; D009025:Morpholines; D000077608:Aprepitant; D017294:Ondansetron