• M W Büchler, C M Seiler, J R T Monson, Y Flamant, M W Thompson-Fawcett, M M Byrne, E R Mortensen, J F B Altman, and R Williamson.
• Department of Surgery, University of Heidelberg, Heidelberg, Germany. markus.buechler@med.uni-heidelberg.de
• Aliment. Pharmacol. Ther. 2008 Aug 1;28(3):312-25.

BackgroundPost-operative ileus (POI) affects most patients undergoing abdominal surgery.AimTo evaluate the effect of alvimopan, a peripherally acting mu-opioid receptor antagonist, on POI by negating the impact of opioids on gastrointestinal (GI) motility without affecting analgesia in patients outside North America.MethodsAdult subjects undergoing open abdominal surgery (n = 911) randomly received oral alvimopan 6 or 12 mg, or placebo, 2 h before, and twice daily following surgery. Opioids were administered as intravenous patient-controlled analgesia (PCA) or bolus injection. Time to recovery of GI function was assessed principally using composite endpoints in subjects undergoing bowel resection (n = 738).ResultsA nonsignificant reduction in mean time to tolerate solid food and either first flatus or bowel movement (primary endpoint) was observed for both alvimopan 6 and 12 mg; 8.5 h (95% CI: 0.9, 16.0) and 4.8 h (95% CI: -3.2, 12.8), respectively. However, an exploratory post hoc analysis showed that alvimopan was more effective in the PCA (n = 317) group than in the non-PCA (n = 318) group. Alvimopan was well tolerated and did not reverse analgesia.ConclusionAlthough the significant clinical effect of alvimopan on reducing POI observed in previous trials was not reproduced, this trial suggests potential benefit in bowel resection patients who received PCA.

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