Alvimopan: A peripheral acting μ-opioid-receptor antagonist used for the treatment of postoperative ileus

Therapy

Volumn 4, Issue 5, 2007, Pages 653-664

  Balsama, Louis ^a   Weese, James ^a  

^a UMDNJ School of Osteopathic Medicine   (United States)

Author keywords

ADL 8 2698; Alvimopan; Ileus; Opioid antagonist; Piperidines

Indexed keywords

ALVIMOPAN; CERULETIDE; CHOLECYSTOKININ; CISAPRIDE; CYCLOOXYGENASE 2 INHIBITOR; DIHYDROERGOTAMINE; ERYTHROMYCIN; KETOROLAC; LOCAL ANESTHETIC AGENT; METOCLOPRAMIDE; MORPHINE; MU OPIATE RECEPTOR ANTAGONIST; NEOSTIGMINE; NONSTEROID ANTIINFLAMMATORY AGENT; OPIATE; PLACEBO; PROPRANOLOL; VALDECOXIB; VASOPRESSIN;

ABDOMINAL CRAMP; ABDOMINAL PAIN; ABDOMINAL SURGERY; ANALGESIC ACTIVITY; ARTICLE; CARDIOVASCULAR DISEASE; CLINICAL TRIAL; CONSTIPATION; DIARRHEA; DRUG APPROVAL; DRUG BIOAVAILABILITY; DRUG EFFECT; DRUG HALF LIFE; DRUG MECHANISM; DRUG STRUCTURE; DRUG WITHDRAWAL; FLATULENCE; FOOD AND DRUG ADMINISTRATION; GASTROINTESTINAL TRACT; HUMAN; HYPOTENSION; ILEUS; INTESTINE FUNCTION; INTESTINE MOTILITY; LIVER TOXICITY; MAXIMUM PLASMA CONCENTRATION; NAUSEA; NERVOUSNESS; NONHUMAN; POLYURIA; POSTOPERATIVE COMPLICATION; SIDE EFFECT; SURGICAL PATIENT; VOMITING;

EID: 35348905618     PISSN: 14750708     EISSN: 1744831X     Source Type: Journal    
DOI: 10.2217/14750708.4.5.653     Document Type: Article

References (74)

1. Kehlet H, Holte K: Review of postoperative ileus. Am. J. Surg. 182(5A Suppl.), 3S-10S (2001).
2. Holte K, Keheler H: Postoperative ileus: a preventable event. Br. J. Surg. 87, 1480-1493 (2000).
3. Brown TA, McDonald J, Williard W: A prospective, randomized, double-blinded, placebo-controlled trial of cisapride after colorectal surgery. Am. J. Surg. 177, 399-401 (1999).
4. Leslie JB: Alvimopan for the management of postoperative ileus. Ann. Pharm. 39, 1502-1510 (2005).
5. Behm B, Stollman N: Postoperative ileus: etiology and interventions. Clin. Gastroenterol. Hepat. 1, 71-80 (2003).
6. Baig MK, Wexner SD: Postoperative ileus: a review. Dis. Colon Rectum 47, 516-526 (2004).
7. Chang SS, Baumgartner RG, Wells N, Cookson MS, Smith JA Jr: Causes of increased hospital stay after radical cystectomy in a clinical pathway setting. J. Urol. 167, 208-211 (2002).
8. Collins TC, Daley J, Henderson WH, Khuri SF: Risk factors for prolonged length of stay after major elective surgery. Ann. Surg. 230, 251-259 (1999).
9. Clevers GJ, Smout AJ: The natural course of postoperative ileus following abdominal surgery. Neth. J. Surg. 41, 97-99 (1989).
10. Prasad M, Matthews JB: Deflating postoperative ileus. Gastroenterology 117, 489-492 (1999).
11. Livingston EH, Passaro EP: Postoperative Ileus. Dig. Dis. Sci. 35, 121-132 (1990).
12. Delaney CP, Senagore AJ, Viscusi ER et al.: Postoperative upper and lower gastrointestinal recovery and gastrointestinal morbidity in patients undergoing bowel resection: pooled analysis of placebo data from 3 randomized controlled trials. Am. J. Surg. 191, 315-319 (2006).
13. Kreis ME: Postoperative nausea and vomiting. Auton. Neurosci. 129(1-2), 86-91 (2006).
14. Esser, MJ, Mahoney JL, Robinson JC, Cowles VE, Condon RE: Effects of adrenergic agents on colonic motility. Surgery 102, 416-523 (1987).
15. Cali RL, Meade PG, Swanson MS, Freeman C: Effect of morphine and incision length on bowel function after colectomy. Dis. Col. Rectum 43, 163-168 (2000).
16. Holzer P, Lippe IT, Amann R: Participation of capsaicin-sensitive afferent neurons in gastric motor inhibition caused by laparotomy and intraperitoneal acid. Neuroscience 48, 715-722 (1992).
17. Zittel TT, Reddy SN, Plourde V, Raybould HE: Role of spinal afferents and calcitonin gene-related peptide in the postoperative ileus in anesthetized rats. Ann. Surg. 219, 79-87 (1994).
18. Kalff JC, Schraut WH, Biliar TR, Simmons RL, Bauer AJ: Role of inducible nitric oxide synthase in postoperative intestinal smooth muscle dysfunction in rat. Surgery 126, 498-509 (2000).
19. Espat NJ, Cheng G, Kelley MC, Vogel SB, Sminsky CA, Hocking MP: Vasoactive intestinal peptide and substance p receptor antagonists improve postoperative ileus. J. Surg. Res. 58, 719-723 (1995).
20. Schmidt WK: Alvimopan (ADL 8-2698) is a novel peripheral opioid antagonist. Am. J. Surg. 182(Suppl.), 27S-38S (2001).
21. Friedman JD, Dello Buono FA: Opioid antagonists in the treatment of opioid-induced constipation and pruritus. Ann. Pharmacother. 35, 85-91 (2001).
22. Bagnol D, Mansour A, Akil H et al.: Cellular localization and distribution of the cloned μ and κ opioid receptors in rat gastrointestinal tract. Neuroscience 81, 579-591 (1997).
23. Fickel J, Bagnol D, Watson SJ et al.: Opioid receptor expression in the rat gastrointestinal tract: a quantitative study with comparison to the brain. Brain Res. Mol. Brain Res. 46, 1-8 (1997).
24. De Luca A, Coupar IM: Insights into opioid action in the intestinal tract. Pharmacol. Ther. 69, 103-115 (1996).
25. Shook JE, Pelton JT, Hruby VJ et al.: Peptide opioid antagonist separates peripheral and central opioid antitransit effects. J. Pharmacol. Exp. Ther. 243, 492-500 (1987).
26. Holte K, Kehlet H: Postoperative ileus: progress towards effective management. Drugs 62, 2603-2615 (2002).
27. Pappagallo M: Incidence, prevalence, and management of opioid bowel dysfunction. Am. J. Surg. 182, S11-S18 (2001).
28. Manara L, Bianchetti A: The central and peripheral influences of opioids on gastrointestinal propulsion. Annu. Rev. Pharmacol. Toxicol. 25, 249-273 (1985).
29. Manara L, Bianchi G, Ferretti P et al.: Inhibition of gastrointestinal transit by morphine in rats results primarily from direct drug action on gut opioid sites. J. Pharmacol. Exp. Ther. 237, 945-949 (1986).
30. Yuan CS, Foss JF: Antagonism of gastrointestinal opioid effects. Reg. Anesth. Pain Med. 25, 639-642 (2000).
31. Goldstein JL, Matuszewski KA, Delaney CP et al.: Inpatient economic burden of postoperative ileus associated with abdominal surgery in the United States. J. Clin. Pharm. Ther. 32(2), 82-90 (2007).
32. Nelson R, Tse B, Edwards S: Systematic review of prophylactic nasogastric decompression after abdominal operations. Br. J. Surg. 92, 673-680 (2005).
33. Sands DR, Wexner SD: Nasogastric tubes and dietary advancement after laparoscopic and open colorectal surgery. Nutrition 15. 347-350 (1999).
34. Hallerback B. Carlsen E, Carlsson K et al.: β adrenoceptor blockade in the treatment of postoperative adynamic ileus. Scand. J. Gastroenterol. 22, 149-155 (1987).
35. Hallerback B, Ander S, Glise H: Effect of combined blockade of β-adrenoceptors and acetylcholinesterase in the treatment of postoperative ileus after cholecystectomy. Scand. J. Gastroenterol. 22, 420-424 (1987).
36. Ferraz AA, Wanderley GJ, Santos Jr MA et al.: Effects of propranolol on human postoperative ileus. Dig. Surg. 18, 305-310 (2001).
37. Altaparmakov I, Erckenbrecht JF. Wienbeck M: Modulation of the adrenergic system in the treatment of postoperative bowel atonia. Scand. J. Gastroenterol. 19, 1104-1106 (1984).
38. Thorup J, Wille-Jorgensen P, Jorgensen T et al.: Dihydroergotamine in postoperative lieus. Clin. Pharmacol. Ther. 34, 54-55 (1983).
39. Kreis ME, Kasparek M, Zittel TT et al.: Neostigmine increases postoperative colonic motility in patients undergoing colorectal surgery. Surgery 130, 449-456 (2001).
40. Myrhoj T, Olsen O. Wengel B: Neostigmine in postoperative intestinal paralysis. A double-blind, clinical, controlled trial. Dis. Colon Rectum 31, 378-379 (1988).
41. Smith AJ, Nissan A, Lanouette NM et al.: Prokinetic effect of erythromycin after colorectal surgery: randomized, placebo-controlled, double-blind study. Dis. Colon Rectum 43, 333-337 (2000).
42. Bonacini M, Quiason S, Reynolds M et al.: Effect of intravenous erythromycin on postoperative ileus. Am. J. Gastroenterol. 88, 208-211 (1993).
43. Tollesson PO, Cassuto J, Rimback G et al.: Treatment of postoperative paralytic ileus with cisapride. Scand. J. Gastroenterol. 26, 477-482 (1991).
44. Brown TA, McDonald J, Williard W: A prospective, randomized, double-blinded, placebo-controlled trial of cisapride after colorectal surgery. Am. J. Surg. 177, 399-401 (1999).
45. Boghaert A, Haesaert G, Mourisse P et al.: Placebo controlled trial of cisapride in postoperative ileus. Acta Anaesthesiol. Belg. 38, 195-199 (1987).
46. Verlinden M, Michiels G, Boghaert A et al.: Treatment of postoperative gastrointestinal atony. Br. J. Surg. 74, 614-617 (1987).
47. Hallerback H, Bergman B, Bing H: Cisapride in the treatment of postoperative ileus. Aliment Pharmacol. Ther. 5, 503-511 (1991).
48. Benson MJ, Roberts JP, Wingate DL et al.: Small bowel motility following major intra-abdominal surgery: the effects of opiates and rectal cisapride. Gastroenterology 106, 924-936 (1994).
49. Roberts JP, Benson MJ, Rogers J et al.: Effect of cisapride on distal colonic motility in the early postoperative period following left colonic anastomosis. Dis. Colon Rectum. 38, 139-145 (1995).
50. Von Ritter C, Hunter S, Hinder RA: Cisapride does not reduce postoperative paralytic ileus. S. Afr. J. Surg. 25, 19-21 (1987).
51. Cheape JD, Wexner SD, James K et al.: Does metoclopramide reduce the length of ileus after colorectal surgery? A prospective randomized trial. Dis. Colon Rectum 34, 437-441 (1991).
52. Tollesson PO, Cassuto J, Faxen A et al.: Lack of effect of metoclopramide on colonic motility after cholecystectomy. Eur J. Surg. 157, 355-358 (1991).
53. Davidson ED, Hersh T, Brinner RA et al.: The effects of metoclopramide on postoperative ileus. A randomized double-blind study. Ann. Surg. 190, 27-30 (1979).
54. Jepsen S, Klaerke A, Nielsen PH et al.: Negative effect of metoclopramide in postoperative adynamic ileus. A prospective, randomized, double blind study. Br. J. Surg. 73, 290-Z91 (1986).
55. Frisell J, Magnusson I, Leijonmarck CE et al.: The effect of cholecystokinin on postoperative bowel function. Acta Chir. Scand. 151, 557-579 (1985).
56. Sadek SA, Cranford C, Eriksen C et al.: Pharmacological manipulation of adynamic ileus: controlled randomized double-blind study of ceruletide on intestinal motor activity after elective abdominal surgery. Aliment Pharmacol. Ther. 2, 47-54 (1988).
57. Madsen PV, Lykkegaard-Nielsen M, Nielsen OV: Ceruletide reduces postoperative intestinal paralysis. A double blind placebo-controlled trial. Dis. Colon Rectum 26, 159-160 (1983).
58. Hakansson T, Watt-Boolsen S, Olsen O et al.: Postoperative intestinal atony and vasopressin. A randomized study of the effect of administration of vasopressin on the duration of postoperative intestinal atony. Ugeskr. Laeger 147, 3069-3070 (1985).
59. Brandstrup B, Tonneseh H, Beier-Holgersen R et al.: Effects of intravenous fluid restriction on postoperative complications: comparison of two perioperative fluid regimens: a randomized assessor-blinded multicenter trial. Ann. Surg. 238, 641-648 (2003).
60. Lobo DN, Bostock KA, Neal KR et al.: Effect of salt and water balance on recovery of gastrointestinal function after elective colonic resection: a randomized controlled trial. Lancet 359, 1812-18181 (2002).
61. Tjandra JJ, Chan MKY: Systemic review on the short-term outcome of laparoscopic resection for the colon and rectosigmoid cancer. Colorectal Dis. 8, 375-388 (2005).
62. Basse L, Jakobsen DH, Bardram L et al.: Functional recovery after open versus laparoscopic colonic resection: a randomized, blinded study. Ann. Surg. 241, 416-423 (2005).
63. O'Hara DA, Fanciullo G, Hubbard L et al.: Evaluation of the safety and efficacy of ketorolac versus morphine by patient-controlled analgesia for postoperative pain. Pharmacotherapy 17, 891-899 (1997).
64. Sim R, Cheong D, Wong KS, Lee B, Liew QY: Prospective randomized, double blind, placebo-controlled study of pre-and postoperative administration of a COX-2-specific inhibitor as opioid-sparing analgesia in major colorectal resections. Colorectal Dis. 9(1), 52-60 (2007).
65. Zimmerman DM, Gidda JS, Cantrell BE et al.: Discovery of a potent, peripherally selective trans-3,4-dimethyl-4-(3-hydroxyphenyl) piperidine opioid antagonist for the treatment of gastrointestinal motility disorders. J. Med. Chem. 37, 2262-2265 (1994).
66. Zimmerman DM, Gidda JS, Cantrell BE et al.: LY246736 dihydrate μ-opioid receptor antagonist. Drugs Future 19, 1078-1083 (1994).
67. Liu SS, Hodgson PS, Carpenter RL, Fricke RL: ADL 8-2698, a trans-3,4-dimethyl-4-(3-hydorxyphenyl) piperidine, prevents gastrointestinal effects of intravenous morphine without affecting analgesia. Clin. Pharmacol. Ther. 69(1), 66-71 (2001).
68. Taguchi A, Sharma N. Saleem RM et al.: Selective postoperative inhibition of gastrointestinal opioid receptors. N. Engl. J. Med. 345(13), 935-940 (2001).
69. Delaney CP, Weese JL, Hyman NH et al.: Phase III Trial of alvimopan, a novel, peripherally acting, μ opioid antagonist, for postoperative ileus after major abdominal surgery. Dis. Col. Rectum 48, 1114-1129 (2005).
70. Wolff BG, Michelassi F, Gerkin TM et al.: Alvimopan. a novel, peripherally acting μ-opioid antagonist: results of a multicenter, randomized, double-blinded, placebo-controlled, Phase III trial of major abdominal surgery and postoperative ileus. Ann. Surg. 240, 728-735 (2004).
71. Herzog TJ, Coleman RL, Guerrieri JP Jr 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. Ob. Gyn. 195, 445-453 (2006).
72. Viscusi ER, Goldstein S, Witkowski T et al.: Alvimopan, a peripherally acting μ-opioid receptor antagonist, compared with placebo in postoperative ileus after major abdominal surgery. Results of a randomized, double-blinded, controlled study. Surg. End. 20. 64-70 (2006).
73. Wolff BG. Weese JL, Ludwig KA et al.: Postoperative ileus-related morbidity profile in patients treated with Alvimopan after bowel resection. J. Am. Coll. Surg. 204(4), 609-616 (2007).
74. Paulson DM, Kennedy DT, Donovick RA et al.: Alvimopan: an oral, peripherally acting μ-opioid receptor antagonist for the treatment of opioid-induced bowel dysfunction-a 21 day treatment-randomized clinical trial. J. Pain 6(3), 184-192 (2005).