Alvimopan, for postoperative ileus following bowel resection: a pooled analysis of phase III studies.

OBJECTIVE: To obtain further analysis regarding specific outcomes and alvimopan doses in bowel resection (BR) patients.

SUMMARY BACKGROUND DATA: Although postoperative ileus (POI) is common after BR, there is currently no recognized treatment or prevention available. Alvimopan, a novel, peripherally active mu-opioid receptor antagonist, accelerated GI recovery after BR or hysterectomy in 3 phase III trials.

METHODS: A pooled retrospective subset analysis of BR patients in alvimopan phase III trials was performed. Randomized BR patients received alvimopan 6 mg (n = 397), 12 mg (n = 413), or placebo (n = 402) >or=2 hours before surgery and twice daily until hospital discharge for
RESULTS: Alvimopan (6 or 12 mg) significantly accelerated GI recovery (GI-3; hazard ratio = 1.28 and 1.38, respectively; P
CONCLUSIONS: Alvimopan significantly accelerated GI recovery in BR patients. A 12-mg dose provided more consistent benefits across both sexes and all ages. Postoperative morbidity rates, prolonged hospital stay, and rates of hospital readmission were significantly reduced. Alvimopan reduces the consequences of POI after BR.