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Phase III Trial of Alvimopan, a Novel, Peripherally Acting, Mu Opioid Antagonist, for Postoperative Ileus After Major Abdominal Surgery

  • Original Contributions
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Diseases of the Colon & Rectum

PURPOSE

Postoperative ileus presents significant clinical challenges that potentially prolong hospital stay, contribute to readmission, and increase morbidity. There is no approved treatment for postoperative ileus. Alvimopan is a novel, peripherally acting, mu opioid receptor antagonist currently in development for the management of postoperative ileus.

METHODS

Patients undergoing partial colectomy or simple or radical hysterectomy were randomized to receive alvimopan 6 mg (n = 152), alvimopan 12 mg (n = 146), or placebo (n = 153) orally 2 hours before surgery and twice daily thereafter until discharge or for up to seven days. The primary efficacy end point, time to return of gastrointestinal function, was a composite measure of passage of flatus or stool and tolerating solid food. Secondary end points included time to the hospital discharge order written. Adverse events were monitored throughout the study.

RESULTS

Mean time to gastrointestinal recovery was significantly reduced in patients treated with alvimopan 6 mg vs. placebo (hazard ratio = 1.45; P = 0.003), with a smaller reduction seen with alvimopan 12 mg (hazard ratio = 1.28; P = 0.059). Mean time to the hospital discharge order written was significantly accelerated in patients treated with alvimopan 6 mg (hazard ratio = 1.50; P < 0.001). The most common treatment-emergent adverse events across all treatment groups were nausea, vomiting, and hypotension; the incidence of nausea and vomiting was reduced by 53 percent in the alvimopan 12-mg group.

CONCLUSIONS

In patients undergoing major abdominal surgery, alvimopan accelerated gastrointestinal recovery and time to the hospital discharge order written compared with placebo and was well tolerated.

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To the Editorial Comment

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ACKNOWLEDGMENTS

The following investigators and institutions participated in the Alvimopan Postoperative Ileus Study Group for study 14CL302 (listed alphabetically by last name of the primary investigators): Shireen Ahmad, M.D., Northwestern University Medical School, Chicago, IL; H. Randolph Bailey, M.D., Baylor College of Medicine, Houston, TX; Joel Bauer, M.D., Mount Sinai School of Medicine, New York, NY; Sander R. Binderow, M.D., Atlanta Colon and Rectal Surgeons, Atlanta, GA; Christine Brody, M.D., The Damluji Research Center Medical Center, Oceanside, CA; Michael A. Choti, M.D., The Johns Hopkins Hospital, Baltimore, MD; Robert L. Coleman, M.D., Parkland Health and Hospital System, Dallas, TX; Conor P. Delaney, M.D., Ph.D., The Cleveland Clinic Foundation, Cleveland, OH; Robert Donoway, M.D., Horizon Institute For Clinical Research, Hollywood, FL; Richard C. Earnhardt, M.D., Surgical Associates of Fredericksburg, Fredericksburg, VA; Edward J. Eyring, II, M.D., Wasatch Clinical Research, Salt Lake City, UT; James W. Fleshman, Jr., M.D., Washington University School of Medicine, St. Louis, MO; Gerard J. Fulda, M.D., Christiana Care Health System, Newark, DE; Susan Galandiuk, M.D., University of Louisville Hospital, Louisville, KY; Todd M. Gerkin, M.D., Central Carolina Surgery, Greensboro, NC; Stephen Gordon, M.D., Comprehensive NeuroScience, Inc., Atlanta, GA; Richard H. Greenberg, M.D., Albert Einstein Medical Center, Philadelphia, PA; Roy Greengrass, M.D., Mayo Clinic Jacksonville, Jacksonville, FL; Francis J. Harford, M.D., Loyola University Medical Center, Maywood, IL; William E. Haun, M.D., Surgical Consultants of Denver, Denver, CO; Neil H. Hyman, M.D., Fletcher Allen Health Care, Burlington, VT; Daniel G. Lorch, Jr., M.D., PAB Clinical Research, Brandon, FL; Robert D. Madoff, M.D., Abbott Northwestern Hospital, Minneapolis, MN; Ronald Medak, M.D., The Damluji Research Center Medical Center, Oceanside, CA; Andrew Menzin, M.D., North Shore University Hospital, Manhasset, NY; Edward Michna, M.D., Brigham & Women’s Hospital, Boston, MA; Benjie B. Mills, M.D., Center for Women’s Medicine, Greenville, SC; Wade Naziri, M.D., Carolina Research Center, Greenville, NC; Lars Newsome, M.D., Scripps Memorial Hospital, La Jolla, CA; Michael Pearl, M.D., State University of New York at Stony Brook, Stony Brook, NY; Janice Rafferty, M.D., University of Cincinnati College of Medicine, Cincinnati, OK; Miguel A. Rodriguez-Bigas, M.D., M.D. Anderson Cancer Center, Houston, TX; Rabih Salloum, M.D., University of Rochester Medical Center, Rochester, NY; Armando Sardi, M.D., St. Agnes HealthCare, Baltimore, MD; Paul W. Schroeder, M.D., Medford Women’s Clinic, LLP, Medford, OR; James V. Sitzmann, M.D., University of Rochester Medical Center, Rochester, NY; Ronald P. Spencer, M.D., Renstar Medical Research, Ocala, FL; Thomas Stahl, M.D., Washington Hospital Center, Washington, DC; Michael L. Twede, M.D., Salt Lake Women’s Center, Salt Lake City, UT; Stephen Unger, M.D., Mt. Sinai Medical Center, Miami Beach, FL; Eugene R. Viscusi, M.D., Thomas Jefferson University Hospital, Philadelphia, PA; James L. Weese, M.D., UMDNJ-School of Osteopathic Medicine, Stratford, NJ.

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Authors and Affiliations

  1. Department of Colorectal Surgery, The Cleveland Clinic Foundation, Cleveland, Ohio

    Conor P. Delaney M.D., Ph.D.

  2. School of Osteopathic Medicine, University of Medicine and Dentistry of New Jersey, Stratford, New Jersey

    James L. Weese M.D.

  3. Division of General Surgery, Fletcher Allen Health Care, Burlington, Vermont

    Neil H. Hyman M.D.

  4. Department of Surgery, The Mount Sinai School of Medicine, New York, New York

    Joel Bauer M.D.

  5. Adolor Corporation, Exton, Pennsylvania

    Lee Techner D.P.M., Kathie Gabriel R.N., Wei Du Ph.D., William K. Schmidt Ph.D. & Bruce A. Wallin M.D.

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  1. Conor P. Delaney M.D., Ph.D.
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Delaney, C., Weese, J., Hyman, N. et al. Phase III Trial of Alvimopan, a Novel, Peripherally Acting, Mu Opioid Antagonist, for Postoperative Ileus After Major Abdominal Surgery. Dis Colon Rectum 48, 1114–1129 (2005). https://doi.org/10.1007/s10350-005-0035-7

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