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.
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.
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).
These post hoc analyses support that alvimopan (12 mg) accelerates GI recovery across various patient populations.
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Accepted: July 1, 2007
Support for these studies and funding for medical editorial assistance was provided by Adolor Corporation, Exton, Penn, and GlaxoSmithKline, Philadelphia, Penn.
© 2007 Mosby, Inc. Published by Elsevier Inc. All rights reserved.