Background
Postoperative ileus is a transient cessation of bowel motility that occurs after bowel
resection (BR). Alvimopan, a peripherally acting μ-opioid receptor antagonist accelerated
gastrointestinal (GI) recovery in 5 randomized, double-blind, phase III postoperative
ileus trials.
Methods
Individual covariates (age, gender, race) were assessed separately using Cox proportional
hazards models that included the main effects of treatment and covariate factor. Time-to-GI
recovery (GI-3 [first toleration of solid food and first bowel movement or flatus];
GI-2 [first toleration of solid food and first bowel movement]) for patients who underwent
open laparotomy for BR in the absence of epidural anesthesia and received alvimopan
(12 mg) or placebo was analyzed within subgroups (age, gender, race, concomitant medication
use) using Cox proportional hazards models to generate hazard ratios (HRs). P values
were calculated with the Wald χ2 test.
Results
Elderly (≥65 years), male, and nonwhite patients achieved GI-3 recovery later than
younger (<65 years), female, and white patients (HR > 1 and P < .05 for all). Overall, alvimopan (12 mg) accelerated GI-3 recovery by 12 hours
and GI-2 recovery by 17 hours compared with placebo. Within subgroups, regardless
of covariate effect, patients who received alvimopan (12 mg) achieved GI-2 and GI-3
recovery sooner than patients who received placebo (HR > 1 and P < .05 for all).
Conclusions
These post hoc analyses support that alvimopan (12 mg) accelerates GI recovery across
various patient populations.
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Article info
Publication history
Accepted:
July 1,
2007
Footnotes
Support for these studies and funding for medical editorial assistance was provided by Adolor Corporation, Exton, Penn, and GlaxoSmithKline, Philadelphia, Penn.
Identification
Copyright
© 2007 Mosby, Inc. Published by Elsevier Inc. All rights reserved.