Document Detail


Phase II study to evaluate the safety and efficacy of the oral neurokinin-1 receptor antagonist casopitant (GW679769) administered with ondansetron for the prevention of postoperative and postdischarge nausea and vomiting in high-risk patients.
MedLine Citation:
PMID:  20526194     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: In recent years, there has been an increased interest in using a multimodal approach with combined agents to treat postoperative nausea and vomiting. This study evaluated whether the addition of an oral dose of the neurokinin-1 receptor antagonist casopitant improved the antiemetic efficacy of an intravenous dose of ondansetron hydrochloride.
METHODS: The authors enrolled 702 premenopausal or perimenopausal, nonsmoking, female patients aged 18-55 yr with a history of postoperative nausea and vomiting and/or motion sickness undergoing a laparoscopic or laparotomic gynecologic surgical procedure or laparoscopic cholecystectomy with general anesthesia. Subjects were randomized to one of five treatment arms: standard ondansetron 4 mg with casopitant at 0, 50, 100, or 150 mg, or 0 mg ondansetron with casopitant at 150 mg (the latter arm was considered an exploratory study group and was included in the safety analysis but not in the efficacy analysis).
RESULTS: A significantly greater proportion of patients in all of the active casopitant plus ondansetron groups achieved a complete response (i.e., no vomiting, retching, rescue medication, or premature withdrawal) during the first 24 h postoperatively versus those in the ondansetron-alone group (59-62% vs. 40%, respectively; P = 0.0006). All active doses seemed to be well tolerated; headache, dizziness, and constipation were the most frequently reported adverse events.
CONCLUSIONS: Compared with ondansetron alone, the casopitant and ondansetron combination results in superior emesis prevention during the first 24 h postoperatively in female patients with known risk factors for postoperative nausea and vomiting.
Authors:
Neil K Singla; Sonia K Singla; Frances Chung; Demetrios J Kutsogiannis; Linda Blackburn; Stephen R Lane; Jeremey Levin; Brendan Johnson; Joseph V Pergolizzi
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Publication Detail:
Type:  Clinical Trial, Phase II; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Anesthesiology     Volume:  113     ISSN:  1528-1175     ISO Abbreviation:  Anesthesiology     Publication Date:  2010 Jul 
Date Detail:
Created Date:  2010-06-25     Completed Date:  2010-07-22     Revised Date:  2011-01-07    
Medline Journal Info:
Nlm Unique ID:  1300217     Medline TA:  Anesthesiology     Country:  United States    
Other Details:
Languages:  eng     Pagination:  74-82     Citation Subset:  AIM; IM    
Affiliation:
Lotus Clinical Research Inc, Huntington Hospital, Pasadena, California 91105, USA. neil@lotuscr.com
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00108095
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MeSH Terms
Descriptor/Qualifier:
Administration, Oral
Adolescent
Adult
Anesthesia, General / methods
Antiemetics / administration & dosage*,  adverse effects
Cholecystectomy, Laparoscopic
Constipation / chemically induced
Dizziness / chemically induced
Dose-Response Relationship, Drug
Double-Blind Method
Drug Therapy, Combination
Female
Gynecologic Surgical Procedures
Headache / chemically induced
Humans
Middle Aged
Ondansetron / administration & dosage*
Piperazines / administration & dosage*,  adverse effects
Piperidines / administration & dosage*,  adverse effects
Postoperative Nausea and Vomiting / prevention & control*
Receptors, Neurokinin-1 / antagonists & inhibitors*
Risk Factors
Treatment Outcome
Young Adult
Chemical
Reg. No./Substance:
0/Antiemetics; 0/Piperazines; 0/Piperidines; 0/Receptors, Neurokinin-1; 0/casopitant; 99614-02-5/Ondansetron
Comments/Corrections
Comment In:
Anesthesiology. 2011 Jan;114(1):224-5; author reply 225   [PMID:  21178684 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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