BJA Advance Access originally published online on May 30, 2007
British Journal of Anaesthesia 2007 99(2):202-211; doi:10.1093/bja/aem133
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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
1 Services d'Anesthesiologie-Reanimation Chirurgicale, CHU, Hôpital de Hautepierre, 1 Avenue de Moliere, Strasbourg 67000, France
2 Department of Anesthesiology, Duke University Medical Centre, Durham, NC 27710, USA
3 Department of Anesthesiology, Perioperative and Pain Medicine, Brigham and Women's Hospital, 75 Francis Street, Boston, MA 02115, USA
4 Universidade Federal de Sao Paulo, Rua Napoleao de Barros, 715-7 o ander, Sao Paulo, Brazil
5 University of Marburg, Abteilung Anaesthesie und Intensivetherapie, Baldingerstr. 1, Marburg, Germany
6 Department of Anaesthesiology, University of Hong Kong, 102 Pokfulam Road, Pokfulam, Hong Kong, Republic of China
7 Clinica Universitaria de Navarra, Avda. Pio XII, 36, Pamplona, Navarra 31008, Spain
8 Department of Anesthesiology, University of Pittsburgh Medical Center, 5230 Centre Avenue, M-140, Pittsburgh, PA 15232, USA
9 Merck Research Laboratories, West Point, PA 19486, USA
* Corresponding author: Services d'Anesthesiologie-Reanimation Chirurgicale, CHU, Hôpitale de Hautepierre, 1 Avenue de Moliere, Strasbourg 67000, France. E-mail: pierre.diemunsch{at}chru-strasbourg.fr
Background: The neurokinin1 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.
Keywords: aprepitant; clinical trials; PONV; ondansetron; serotonin (5-hydroxy-tryptamine), antagonism
Declaration of interest. This study was funded by Merck and Co., Inc. (Sponsor), West Point, PA 19486, USA. Drs Diemunsch, Gan, Philip, Girao, Eberhart, Irwin, Pueyo and Chelly received funding from Merck to perform the study. Drs Carides, Reiss, Evans and Lawson are employees of Merck and hold stock options or stock in Merck.
Participating primary investigators are listed in Acknowledgements.
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