• J Hosp Med · Feb 2012

    Randomized Controlled Trial Multicenter Study

    Subcutaneous methylnaltrexone for treatment of acute opioid-induced constipation: phase 2 study in rehabilitation after orthopedic surgery.

    • Lucas Anissian, Harry W Schwartz, Kevin Vincent, Heather K Vincent, Jennifer Carpenito, Nancy Stambler, and Tage Ramakrishna.
    • Department of Orthopaedic Surgery, Louisiana State University Health Sciences Center-Shreveport, Shreveport, LA 71130-3932, USA. Laniss@lsuhsc.edu
    • J Hosp Med. 2012 Feb 1;7(2):67-72.

    BackgroundMethylnaltrexone has been shown to be effective for treating opioid-induced constipation (OIC) in chronic settings, but its effects on acute OIC have not been studied.ObjectiveTo assess safety and efficacy of subcutaneous methylnaltrexone in patients with acute OIC after orthopedic procedures.DesignDouble-blind, randomized, parallel-group, placebo-controlled, hypothesis-generating phase 2 study.SettingSixteen US hospitals and rehabilitation facilities.PatientsAdult patients with acute OIC after orthopedic surgical procedure, expected to require opioids for at least 7 days postrandomization.InterventionsPatients received once-daily subcutaneous methylnaltrexone 12 mg or placebo for up to 4 or 7 days.MeasurementsAll endpoints were exploratory and included the percentage of patients achieving laxation within 2 and 4 hours of first dose and time to laxation.ResultsThirty-three patients received at least 1 dose of study drug (methylnaltrexone, n = 18; placebo, n = 15). Within 2 and 4 hours, significantly more patients receiving methylnaltrexone achieved laxation (2 hours: 33.3% vs 0%, P = 0.021; 4 hours: 38.9% vs 6.7%, P = 0.046) compared with placebo. Time to laxation was significantly shorter with methylnaltrexone (median = 15.8 hours) versus placebo (median = 50.9 hours), P = 0.0197. The most common adverse events related to the gastrointestinal tract. Pain scores remained stable and were similar to those of placebo, and signs and symptoms of opioid withdrawal did not emerge in patients receiving methylnaltrexone.ConclusionsMethylnaltrexone was generally well tolerated and was active in inducing laxation in this study of patients experiencing acute OIC following orthopedic surgery.Copyright © 2011 Society of Hospital Medicine.

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