Alvimopan accelerates gastrointestinal recovery after bowel resection regardless of age, gender, race, or concomitant medication use.
BACKGROUND
Postoperative ileus is a transient cessation of bowel motility that occurs after bowel resection (BR). Alvimopan, a peripherally acting mu-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 chi2 test.


RESULTS
Elderly (>or=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.
Senagore
Anthony J
AJ
Spectrum Health System, Research and Medical Education, Grand Rapids, Michigan 49503, USA. anthony.senagore@spectrum-health.org
Bauer
Joel J
JJ
Du
Wei
W
Techner
Lee
L
D017677:Age Distribution; D017326:Clinical Trials, Phase III as Topic / Q000706:statistics & numerical data; D005765:Gastrointestinal Agents / Q000627:therapeutic use*; D005767:Gastrointestinal Diseases / Q000188:drug therapy* / Q000601:surgery*; D006801:Humans; D015337:Multicenter Studies as Topic / Q000706:statistics & numerical data; D010880:Piperidines / Q000627:therapeutic use*; D011183:Postoperative Complications / Q000188:drug therapy*; D044469:Racial Groups; D016032:Randomized Controlled Trials as Topic / Q000706:statistics & numerical data; D020127:Recovery of Function / Q000187:drug effects; D017678:Sex Distribution
D005765:Gastrointestinal Agents; D010880:Piperidines; C419502:alvimopan