On “Pathogenesis and Management of Postoperative Ileus” (Clin Colon Rectal Surg 2009;22:47–50)

I read with great interest the article in your Volume 22 issue by Carroll and Alavi regarding the pathogenesis and management of postoperative ileus (POI).[1] Alvimopan was reviewed by the authors and concluded to show “promise in reducing POI, but needs more rigorous investigation.”

Alvimopan has been extensively evaluated for the management of gastrointestinal (GI) recovery (POI) in five large, randomized, double-blind, placebo-controlled phase 3 clinical trials (>3,000 patients). The results from these clinical trials have all been published in peer-reviewed journals.[2] [3] [4] [5] [6] Furthermore, alvimopan was ultimately approved by the U.S. Food and Drug Administration in 2008 to accelerate the time to upper and lower GI recovery following partial large or small bowel resection surgery with primary anastomosis.[7]

Although the information presented in the article is accurate, it is also incomplete. This additional information, which was not referenced in the original article, may help provide perspective to the reader about the current state of development of alvimopan.

Thank you for the opportunity to comment on this interesting paper by Carroll and Alavi.

REFERENCES

• 1 Carroll J, Alavi K. Pathogenesis and management of postoperative ileus.  Clin Colon Rectal Surg. 2009;  22(1) 47-50
• 2 Wolff B G, Michelassi F, Gerkin T M Alvimopan Postoperative Ileus Study Group et al. Alvimopan, a novel, peripherally acting mu opioid antagonist: results of a multicenter, randomized, double-blind, placebo-controlled, phase III trial of major abdominal surgery and postoperative ileus.  Ann Surg. 2004;  240(4) 728-734 discussion 734-735
• 3 Delaney C P, Weese J L, Hyman N H Alvimopan Postoperative Ileus Study Group et al. Phase III trial of alvimopan, a novel, peripherally acting, mu opioid antagonist, for postoperative ileus after major abdominal surgery.  Dis Colon Rectum. 2005;  48(6) 1114-1125 discussion 1125-1126 author reply 1127-1129
• 4 Herzog T J, Coleman R L, Guerrieri Jr J P et al.. A double-blind, randomized, placebo-controlled phase III study of the safety of alvimopan in patients who undergo simple total abdominal hysterectomy.  Am J Obstet Gynecol. 2006;  195(2) 445-453
• 5 Viscusi E R, Goldstein S, Witkowski T et al.. Alvimopan, a peripherally acting mu-opioid receptor antagonist, compared with placebo in postoperative ileus after major abdominal surgery: results of a randomized, double-blind, controlled study.  , [published erratum appears in Surg Endosc 2006;20:537] Surg Endosc. 2006;  20(1) 64-70
• 6 Ludwig K, Enker W E, Delaney C P et al.. Gastrointestinal tract recovery in patients undergoing bowel resection: results of a randomized trial of alvimopan and placebo with a standardized accelerated postoperative care pathway.  Arch Surg. 2008;  143(11) 1098-1105
• 7 Adolor Corporation .Entereg^® (alvimopan) capsules. Prescribing information. Available at: http://www.entereg.com/pdf/prescribing-information.pdf Accessed January 5, 2010