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) ≥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.
Original language | English (US) |
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Pages (from-to) | 445-453 |
Number of pages | 9 |
Journal | American journal of obstetrics and gynecology |
Volume | 195 |
Issue number | 2 |
DOIs | |
State | Published - Aug 2006 |
Keywords
- Alvimopan
- Hysterectomy
- Phase III trial
- Postoperative ileus
ASJC Scopus subject areas
- Obstetrics and Gynecology