A double-blind, randomized, placebo-controlled phase III study of the safety of alvimopan in patients who undergo simple total abdominal hysterectomy - 18/08/11
, Robert L. Coleman, MD b, James P. Guerrieri, MD c, Kathie Gabriel, RN d, Wei Du, PhD d, Lee Techner, DPM d, John G. Fort, MD d, Bruce Wallin, MD d
Reprint requests: Thomas J. Herzog, MD, Columbia University, 161 Fort Washington Ave, New York, NY 10032.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.
Le texte complet de cet article est disponible en PDF.Key words : Alvimopan, Hysterectomy, Phase III trial, Postoperative ileus
Plan
| Supported by Adolor Corporation (Exton, PA) and GlaxoSmithKline (Philadelphia, PA). |
Vol 195 - N° 2
P. 445-453 - août 2006 Retour au numéro
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