Document Detail


Safety and efficacy of methylnaltrexone in shortening the duration of postoperative ileus following segmental colectomy: results of two randomized, placebo-controlled phase 3 trials.
MedLine Citation:
PMID:  21471758     Owner:  NLM     Status:  In-Data-Review    
Abstract/OtherAbstract:
PURPOSE: : Postoperative ileus contributes to surgical morbidity and is associated with prolonged hospitalization and increased health care costs. The efficacy and safety of the peripherally acting μ-opioid receptor antagonist methylnaltrexone in shortening the duration of postoperative ileus following segmental colectomy was evaluated.
METHODS: : Two identically designed, multicenter, double-blind, parallel-group, placebo-controlled studies randomly assigned patients undergoing segmental colectomy (study 1, N = 515; study 2, N = 533) to receive 12 or 24 mg of methylnaltrexone intravenously or placebo every 6 hours starting within 90 minutes of surgery completion, continuing for up to 10 days or up to 24 hours after gastrointestinal recovery. The primary efficacy end point was the time from the end of surgery to the first bowel movement. Safety was evaluated via standard assessments (ie, adverse events and related withdrawals, physical examinations, laboratory tests, vital signs, electrocardiograms) and assessment of surgical complications.
RESULTS: : The primary and secondary efficacy outcomes (time to discharge eligibility, time to hospital discharge, and clinically meaningful events of nausea and vomiting following segmental colectomy) did not differ significantly between patients treated with either a dose of methylnaltrexone or with placebo. Rates of adverse events and serious adverse events were comparable across all treatment groups in both studies. The most commonly observed adverse events were nausea, pyrexia, and vomiting.
CONCLUSIONS: : Although the efficacy of methylnaltrexone in reducing the duration of postoperative ileus was not demonstrated in these studies, intravenous methylnaltrexone at doses of 12 mg and 24 mg was safe, in general, and well tolerated in postcolectomy patients. The utility of intravenous methylnaltrexone in treating postoperative ileus remains unproven.
Authors:
Chang Sik Yu; Ho-Kyung Chun; Nancy Stambler; Jennifer Carpenito; Seth Schulman; Evan Tzanis; Bruce Randazzo
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Diseases of the colon and rectum     Volume:  54     ISSN:  1530-0358     ISO Abbreviation:  Dis. Colon Rectum     Publication Date:  2011 May 
Date Detail:
Created Date:  2011-04-07     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0372764     Medline TA:  Dis Colon Rectum     Country:  United States    
Other Details:
Languages:  eng     Pagination:  570-8     Citation Subset:  IM    
Affiliation:
1University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea 2Samsung Medical Center, Seoul, Korea 3Progenics Pharmaceuticals, Tarrytown, New York 4Pfizer Inc, Collegeville, Pennsylvania.
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