Preventing postoperative nausea and vomiting: Post hoc analysis of pooled data from two randomized active-controlled trials of aprepitant

Pierre Diemunsch, Christian Apfel, Tong J. Gan, Keith A Candiotti, Beverly K. Philip, Jacques Chelly, Alexandra D. Carides, Judith K. Evans, Tony W. Ho, Theodore Reiss

Research output: Contribution to journalArticle

35 Citations (Scopus)

Abstract

Objective: Compared with the 5HT3 antagonist ondansetron, the NK1 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. Research design and 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. Main outcome measures: 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 postoperative nausea and vomiting.

Original languageEnglish
Pages (from-to)2559-2565
Number of pages7
JournalCurrent Medical Research and Opinion
Volume23
Issue number10
DOIs
StatePublished - Oct 1 2007

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aprepitant
Postoperative Nausea and Vomiting
Nausea
Randomized Controlled Trials
Ondansetron
Vomiting
Gynecologic Surgical Procedures
General Anesthesia
Research Design

Keywords

  • Antiemetic
  • Aprepitant
  • Emesis
  • NK antagonist
  • Ondansetron
  • Postoperative nausea and vomiting

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Preventing postoperative nausea and vomiting : Post hoc analysis of pooled data from two randomized active-controlled trials of aprepitant. / Diemunsch, Pierre; Apfel, Christian; Gan, Tong J.; Candiotti, Keith A; Philip, Beverly K.; Chelly, Jacques; Carides, Alexandra D.; Evans, Judith K.; Ho, Tony W.; Reiss, Theodore.

In: Current Medical Research and Opinion, Vol. 23, No. 10, 01.10.2007, p. 2559-2565.

Research output: Contribution to journalArticle

Diemunsch, Pierre ; Apfel, Christian ; Gan, Tong J. ; Candiotti, Keith A ; Philip, Beverly K. ; Chelly, Jacques ; Carides, Alexandra D. ; Evans, Judith K. ; Ho, Tony W. ; Reiss, Theodore. / Preventing postoperative nausea and vomiting : Post hoc analysis of pooled data from two randomized active-controlled trials of aprepitant. In: Current Medical Research and Opinion. 2007 ; Vol. 23, No. 10. pp. 2559-2565.
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abstract = "Objective: Compared with the 5HT3 antagonist ondansetron, the NK1 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. Research design and 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. Main outcome measures: 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 postoperative nausea and vomiting.",
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AU - Diemunsch, Pierre

AU - Apfel, Christian

AU - Gan, Tong J.

AU - Candiotti, Keith A

AU - Philip, Beverly K.

AU - Chelly, Jacques

AU - Carides, Alexandra D.

AU - Evans, Judith K.

AU - Ho, Tony W.

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N2 - Objective: Compared with the 5HT3 antagonist ondansetron, the NK1 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. Research design and 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. Main outcome measures: 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 postoperative nausea and vomiting.

AB - Objective: Compared with the 5HT3 antagonist ondansetron, the NK1 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. Research design and 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. Main outcome measures: 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 postoperative nausea and vomiting.

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KW - Emesis

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KW - Ondansetron

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