Meta-analysis: alvimopan vs. placebo in the treatment of post-operative ileus

Authors


Dr P. Tekkis, Imperial College London, Department of Biosurgery and Surgical Technology, St Mary's Hospital, 10th Floor QEQM Wing, Praed Street, London W2 1NY, UK.
E-mail: p.tekkis@imperial.ac.uk

Abstract

Summary

Background

Alvimopan is a selective, competitive μ-opioid receptor antagonist with limited oral bioavailability which may be used to reduce length of post-operative ileus.

Aim

The study compared alvimopan with placebo following bowel resection or total abdominal hysterectomy.

Methods

A meta-analysis of randomized–controlled trials published between 2001 and 2006 of alvimopan vs. placebo was performed. The primary efficacy end-points were composite measures of passage of flatus, stool, and tolerance of solid food (GI-3) and passage of stool and tolerance of solid food (GI-2). The incidence of treatment emergent adverse events was assessed.

Results

Five trials matched the selection criteria, reporting on 2195 patients. A total of 1521 (69.3%) had alvimopan and 674 (30.7%) placebo. GI-3 significantly improved (hazard ratio 1.30; 95% confidence intervals 1.16, 1.45, P < 0.001), as did GI-2 (hazard ratio 1.61; 95% confidence intervals 1.26, 2.05, P < 0.001) on alvimopan 12 mg. Time to discharge (hazard ratio 1.26; 95% confidence intervals 1.13, 1.40, P < 0.001), time to bowel motion (hazard ratio 1.74; 95% confidence intervals 1.29, 2.35, P < 0.001), and time to solid food (hazard ratio 1.14; 95% confidence intervals 1.01, 1.30, P < 0.04) also improved significantly. No difference was noted in the incidence of treatment emergent adverse events.

Conclusions

Alvimopan showed significant advantages over placebo in restoring gastro-intestinal function, and reduced time to discharge following major abdominal surgery, with acceptable side effects.

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