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Am J Obstet Gynecol ; 195(2): 445-53, 2006 Aug.
Article in English | MEDLINE | ID: mdl-16626607

ABSTRACT

OBJECTIVE: The purpose of this study was to investigate the safety and efficacy of alvimopan, a novel peripherally acting mu-opioid receptor antagonist, in patients who undergo simple total abdominal hysterectomy. STUDY DESIGN: Women (n = 519) were randomized (4:1) to receive alvimopan 12 mg (n = 413) or placebo (n = 106) > or = 2 hours before the operation then twice daily for 7 days (hospital and home). Adverse events were monitored up to 30 days after the last dose of study drug was administered. Efficacy was assessed for 7 postoperative days. RESULTS: Overall, the most common adverse events were nausea, vomiting, and constipation; < 5% of patients discontinued use because of adverse events. Alvimopan significantly accelerated the time to first bowel movement (hazard ratio, 2.33; P <.001). Average time to first bowel movement was reduced by 22 hours, with more frequent bowel movement and better bowel movement quality found in the treatment cohort. CONCLUSION: Alvimopan has a safety profile that is similar to that of placebo and provides significantly improved lower gastrointestinal recovery in women who undergo simple total abdominal hysterectomy.


Subject(s)
Defecation/drug effects , Hysterectomy , Piperidines/pharmacology , Adult , Analgesics, Opioid , Double-Blind Method , Female , Gastrointestinal Motility/drug effects , Humans , Leiomyoma/surgery , Middle Aged , Pain Measurement , Piperidines/adverse effects , Postoperative Nausea and Vomiting/chemically induced , Postoperative Nausea and Vomiting/epidemiology , Postoperative Period , Recovery of Function , Uterine Neoplasms/surgery
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