Document Detail


Alvimopan for the management of postoperative ileus after bowel resection: characterization of clinical benefit by pooled responder analysis.
MedLine Citation:
PMID:  20526599     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: A pooled post hoc responder analysis was performed to assess the clinical benefit of alvimopan, a peripherally acting mu-opioid receptor (PAM-OR) antagonist, for the management of postoperative ileus after bowel resection.
METHODS: Adult patients who underwent laparotomy for bowel resection scheduled for opioid-based intravenous patient-controlled analgesia received oral alvimopan or placebo preoperatively and twice daily postoperatively until hospital discharge or for 7 postoperative days. The proportion of responders and numbers needed to treat (NNT) were examined on postoperative days (POD) 3-8 for GI-2 recovery (first bowel movement, toleration of solid food) and hospital discharge order (DCO) written.
RESULTS: Alvimopan significantly increased the proportion of patients with GI-2 recovery and DCO written by each POD (P < 0.001 for all). More patients who received alvimopan achieved GI-2 recovery on or before POD 5 (alvimopan, 80%; placebo, 66%) and DCO written before POD 7 (alvimopan, 87%; placebo, 72%), with corresponding NNTs equal to 7.
CONCLUSIONS: On each POD analyzed, alvimopan significantly increased the proportion of patients who achieved GI-2 recovery and DCO written versus placebo and was associated with relatively low NNTs. The results of these analyses provide additional characterization and support for the overall clinical benefit of alvimopan in patients undergoing bowel resection.
Authors:
Kirk Ludwig; Eugene R Viscusi; Bruce G Wolff; Conor P Delaney; Anthony Senagore; Lee Techner
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Publication Detail:
Type:  Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  World journal of surgery     Volume:  34     ISSN:  1432-2323     ISO Abbreviation:  World J Surg     Publication Date:  2010 Sep 
Date Detail:
Created Date:  2010-08-09     Completed Date:  2010-12-20     Revised Date:  2013-05-29    
Medline Journal Info:
Nlm Unique ID:  7704052     Medline TA:  World J Surg     Country:  United States    
Other Details:
Languages:  eng     Pagination:  2185-90     Citation Subset:  IM    
Affiliation:
Department of Surgery, Medical College of Wisconsin, 9200 West Wisconsin Avenue, Milwaukee, WI 53226, USA. kludwig@mcw.edu
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00205842;  NCT00388258;  NCT00388401;  NCT00388479
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MeSH Terms
Descriptor/Qualifier:
Aged
Colonic Neoplasms / surgery
Digestive System Surgical Procedures / adverse effects*
Diverticulosis, Colonic / surgery
Female
Humans
Ileus / drug therapy*
Intestines / surgery*
Length of Stay
Male
Middle Aged
Piperidines / therapeutic use*
Postoperative Complications / surgery
Receptors, Opioid, mu / antagonists & inhibitors*
Recovery of Function
Rectal Neoplasms / surgery
Treatment Outcome
Chemical
Reg. No./Substance:
0/Piperidines; 0/Receptors, Opioid, mu; 677C126AET/alvimopan
Comments/Corrections

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


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