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Central Surgical Association| Volume 142, ISSUE 4, P478-486, October 2007

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Alvimopan accelerates gastrointestinal recovery after bowel resection regardless of age, gender, race, or concomitant medication use

  • Author Footnotes
    1 Dr Senagore is a member of the Consulting and Advisory Board of Adolor Corporation.
    Anthony J. Senagore
    Correspondence
    Reprint requests: Anthony J. Senagore, MD, Vice President, Research and Medical Education, Spectrum Health, Corporate Administration-MC 005, 100 Michigan Street, NE, Grand Rapids, MI 49503.
    Footnotes
    1 Dr Senagore is a member of the Consulting and Advisory Board of Adolor Corporation.
    Affiliations
    Spectrum Health System, Research and Medical Education, Grand Rapids, Michigan
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  • Joel J. Bauer
    Affiliations
    Department of Surgery, The Mount Sinai School of Medicine, New York, New York
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  • Author Footnotes
    2 Dr Du is a former employee of the Adolor Corporation.
    Wei Du
    Footnotes
    2 Dr Du is a former employee of the Adolor Corporation.
    Affiliations
    Adolor Corporation, Exton, Pennsylvania
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  • Author Footnotes
    3 Dr Tachner is and employee of the Adolor Corporation and a stock holder.
    Lee Techner
    Footnotes
    3 Dr Tachner is and employee of the Adolor Corporation and a stock holder.
    Affiliations
    Adolor Corporation, Exton, Pennsylvania
    Search for articles by this author
  • Author Footnotes
    1 Dr Senagore is a member of the Consulting and Advisory Board of Adolor Corporation.
    2 Dr Du is a former employee of the Adolor Corporation.
    3 Dr Tachner is and employee of the Adolor Corporation and a stock holder.

      Background

      Postoperative ileus is a transient cessation of bowel motility that occurs after bowel resection (BR). Alvimopan, a peripherally acting μ-opioid receptor antagonist accelerated gastrointestinal (GI) recovery in 5 randomized, double-blind, phase III postoperative ileus trials.

      Methods

      Individual covariates (age, gender, race) were assessed separately using Cox proportional hazards models that included the main effects of treatment and covariate factor. Time-to-GI recovery (GI-3 [first toleration of solid food and first bowel movement or flatus]; GI-2 [first toleration of solid food and first bowel movement]) for patients who underwent open laparotomy for BR in the absence of epidural anesthesia and received alvimopan (12 mg) or placebo was analyzed within subgroups (age, gender, race, concomitant medication use) using Cox proportional hazards models to generate hazard ratios (HRs). P values were calculated with the Wald χ2 test.

      Results

      Elderly (≥65 years), male, and nonwhite patients achieved GI-3 recovery later than younger (<65 years), female, and white patients (HR > 1 and P < .05 for all). Overall, alvimopan (12 mg) accelerated GI-3 recovery by 12 hours and GI-2 recovery by 17 hours compared with placebo. Within subgroups, regardless of covariate effect, patients who received alvimopan (12 mg) achieved GI-2 and GI-3 recovery sooner than patients who received placebo (HR > 1 and P < .05 for all).

      Conclusions

      These post hoc analyses support that alvimopan (12 mg) accelerates GI recovery across various patient populations.
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