Meta-analysis: Alvimopan vs. placebo in the treatment of post-operative ileus.
BACKGROUND
Alvimopan is a selective, competitive mu-opioid receptor antagonist with limited oral bioavailability which may be used to reduce length of post-operative ileus.


OBJECTIVE
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.
Tan
E K
EK
Department of Biosurgery and Surgical Technology, St Mary's Hospital, Imperial College, London, UK.
Cornish
J
J
Darzi
A W
AW
Tekkis
P P
PP
D000293:Adolescent; D000328:Adult; D013505:Digestive System Surgical Procedures / Q000009:adverse effects*; D005260:Female; D005769:Gastrointestinal Motility / Q000502:physiology; D006801:Humans; D007044:Hysterectomy / Q000009:adverse effects*; D045823:Ileus / Q000188:drug therapy* / Q000209:etiology / Q000517:prevention & control; D008875:Middle Aged; D010880:Piperidines / Q000627:therapeutic use*; D011183:Postoperative Complications / Q000517:prevention & control; D016032:Randomized Controlled Trials as Topic; D017450:Receptors, Opioid, mu / Q000819:agonists*; D020127:Recovery of Function / Q000502:physiology; D016896:Treatment Outcome
D010880:Piperidines; D017450:Receptors, Opioid, mu; C419502:alvimopan