Economic analysis of alvimopan in North American Phase III efficacy trials

American Journal of Health-System Pharmacy

Volumn 66, Issue 15, 2009, Pages 1362-1368

  Bell, Timothy J ^a   Poston, Sara A ^a   Kraft, Michael D ^b   Senagore, Anthony J ^c   Delaney, Conor P ^d   Techner, Lee ^e  

^a GLAXOSMITHKLINE   (United States)

^b UNIVERSITY OF MICHIGAN   (United States)

^c SPECTRUM HEALTH   (United States)

^d UNIVERSITY HOSPITALS OF CLEVELAND   (United States)

^e ADOLOR CORPORATION   (United States)

Author keywords

Alvimopan; Costs; Hospitals; Ileus; Opiate antagonists; Opiates; Pain; Pharmacoeconomics; Postoperative complications; Toxicity

Indexed keywords

ALVIMOPAN; OPIATE; PLACEBO;

ADULT; AGED; ANEMIA; ARTICLE; BACKACHE; CLINICAL TRIAL; COLON RESECTION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CONVALESCENCE; COST CONTROL; COST EFFECTIVENESS ANALYSIS; DOUBLE BLIND PROCEDURE; DRUG COST; DRUG EFFICACY; DYSPEPSIA; ECONOMIC ASPECT; FEMALE; HOSPITAL COST; HOSPITAL DISCHARGE; HUMAN; HYPOKALEMIA; ILEUS; INTESTINE ANASTOMOSIS; LAPAROTOMY; LENGTH OF STAY; MAJOR CLINICAL STUDY; MALE; NAUSEA; NORTH AMERICA; PATIENT CONTROLLED ANALGESIA; PHASE 3 CLINICAL TRIAL; POSTOPERATIVE CARE; POSTOPERATIVE PAIN; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SMALL INTESTINE RESECTION; URINE RETENTION; VOMITING;

AGED; CLINICAL TRIALS, PHASE III AS TOPIC; DRUG COSTS; ECONOMICS, PHARMACEUTICAL; FEMALE; GASTROINTESTINAL AGENTS; HUMANS; MALE; MIDDLE AGED; NARCOTIC ANTAGONISTS; PIPERIDINES; RANDOMIZED CONTROLLED TRIALS AS TOPIC;

EID: 67650913534     PISSN: 10792082     EISSN: None     Source Type: Journal    
DOI: 10.2146/ajhp080329     Document Type: Article

References (28)

1. Behm B, Stollman N. Postoperative ileus: etiologies and interventions. Clin Gastroenterol Hepatol. 2003; 1:71-80.
2. Livingston EH, Passaro EP Jr. Postoperative ileus. Dig Dis Sci. 1990; 35:121-132
3. Austrup ML, Korean G. Analgesic agents for the postoperative period. Opioids. Surg Clin North Am. 1999; 79:253-273
4. Kehlet H, Holte K. Review of postoperative ileus. Am J Surg. 2001; 182(suppl 5A):3S-10S.
5. Chang SS, Baumgartner RG, Wells N et al. Causes of increased hospital stay after radical cystectomy in a clinical pathway setting.J Urol. 2002; 167:208-211
6. 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. 2006; 191:315-319 (Pubitemid 43265997)
7. Kariv Y, Wang W, Senagore AJ et al. Multivariable analysis of factors associated with hospital readmission after intestinal surgery. Am J Surg. 2006; 191:364-371 (Pubitemid 43266007)
8. Oderda GM, Said Q, Evans RS et al. Opioid-related adverse drug events in surgical hospitalizations: impact on costs and length of stay. Ann Pharmacother. 2007; 41:400-406 (Pubitemid 46536029)
9. 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. 2007; 204:609-616
10. Bosio RM, Delaney CP, Senagore AJ. Economic impact of POI and prolonged length of stay. Semin Colon Rectal Surg. 2005; 16:235-238
11. Goldstein JL, Matuszewski KA, Delaney CP et al. Inpatient economic burden of postoperative ileus associated with abdominal surgery in the United States. P&T. 2007; 32:82-90.
12. Salvador CG, Sikirica M, Evans A et al. Clinical and economic outcomes of prolonged postoperative ileus in patients undergoing hysterectomy and hemicolectomy. P&T. 2005; 30:590-595
13. Sarawate CA, Lin SJ, Walton SM et al. Economic burden of postoperative ileus (POI) in abdominal surgical procedures. Gastroenterology. 2003; 124:A828. Abstract.
14. Carter S. The surgical team and outcomes management: focus on postoperative ileus. J Perianesth Nurs. 2006; 21(suppl 2A):S2-6.
15. Leslie JB. Alvimopan: a peripherally acting mu-opioid receptor antagonist. Drugs Today (Barc). 2007; 43:611-625
16. De Aguilar-Nascimento JE, Kudsk KA. Clinical costs of feeding tube placement. JPEN J Parenter Enteral Nutr. 2007; 31: 269-273 (Pubitemid 47025687)
17. Nehra V, Swails W, Duerksen D et al. Indications for total parenteral nutrition in the hospitalized patient: a prospective review of evolving practice. J Nutr Biochem. 1999; 10:2-7. (Pubitemid 29065471)
18. Entereg (alvimopan) capsules product information. Exton, PA: Adolor Corporation; Research Triangle Park, NC: GlaxoSmithKline; 2008 May.
19. Delaney CP, Weese JL, Hyman NH 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; 48:1114-1129 (Pubitemid 40897853)
20. Ludwig K, Enker WE, Delaney CP 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; 143:1098-1105
21. Viscusi ER, Goldstein S, Witkowski T et al. Alvimopan, a peripherally acting muopioid receptor antagonist, compared with placebo in postoperative ileus after major abdominal surgery: results of a randomized, double-blind, controlled study. Surg Endosc. 2006; 20:64-70.
22. Wolff BG, Michelassi F, Gerkin TM 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; 240:728-735
23. Adolor Corporation. FDA advisory panel briefing document. Entereg (alvimopan) capsules for postoperative ileus. www.fda.gov/ohrms/DOCKETS/ac/08/ briefing/2008-4336b1-02-Adolor.pdf (accessed 2008 Jun 2).
24. Senagore AJ, Kraft M, Du W et al. Alvimopan is associated with reduced hospital length of stay, lowered readmission rates, and decreased costs after bowel resection: pooled data from 4 clinical trials. Poster presented at ASHP Midyear Clinical Meeting. Anaheim, CA; 2006 Dec.
25. Buchler MW, Seiler CM, Monson JR et al. Clinical trial: alvimopan for the management of post-operative ileus after abdominal surgery: results of an international randomized, double-blind, multicenter, placebo-controlled clinical study. Aliment Pharmacol Ther. 2008; 28:312-325
26. U.S. Census Bureau. The 2007 statistical abstract. The national data book. Section 3. Health and nutrition, www.census.gov/prod/2006pubs/07statab/ health.pdf (accessed 2009 Mar 4).
27. U.S. Department of Labor. Bureau of Labor Statistics. Medical Consumer Price Index 2007. http://data.bls.gov/cgi-bin/surveymost (accessed 2008 Jun 2).
28. Delaney CP, Wolff BG, Viscusi ER et al. Alvimopan, for postoperative ileus following bowel resection: a pooled analysis of phase III studies. Ann Surg. 2007; 245: 355-363