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.
Il testo completo di questo articolo è disponibile in PDF.Key words : Alvimopan, Hysterectomy, Phase III trial, Postoperative ileus
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| Supported by Adolor Corporation (Exton, PA) and GlaxoSmithKline (Philadelphia, PA). |
Vol 195 - N° 2
P. 445-453 - agosto 2006 Ritorno al numero
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