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lüll Meta-analysis: Alvimopan vs placebo in the treatment of post-operative ileus Tan EK; Cornish J; Darzi AW; Tekkis PPAliment Pharmacol Ther 2007[Jan]; 25 (1): 47-57BACKGROUND: Alvimopan is a selective, competitive mu-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.|Adolescent[MESH]|Adult[MESH]|Digestive System Surgical Procedures/*adverse effects[MESH]|Female[MESH]|Gastrointestinal Motility/physiology[MESH]|Humans[MESH]|Hysterectomy/*adverse effects[MESH]|Ileus/*drug therapy/etiology/prevention & control[MESH]|Middle Aged[MESH]|Piperidines/*therapeutic use[MESH]|Postoperative Complications/prevention & control[MESH]|Randomized Controlled Trials as Topic[MESH]|Receptors, Opioid, mu/*agonists[MESH]|Recovery of Function/physiology[MESH]|Treatment Outcome[MESH] |