A Retrospective Study of Patients Undergoing Radical Cystectomy and Receiving Peri-Operative Naloxegol or Alvimopan: Comparison of Length of Stay
Journal of Surgery
Volume 6, Issue 5, October 2018, Pages: 129-134
Received: Aug. 27, 2018;
Accepted: Sep. 10, 2018;
Published: Oct. 12, 2018
Views 897 Downloads 100
Taylor Goodstein, Division of Urology, Department of Surgery, University of Colorado Hospital, Aurora, USA
Bryn Launer, Division of Urology, Department of Surgery, University of Colorado Hospital, Aurora, USA
Sharon White, Division of Urology, Department of Surgery, University of Colorado Hospital, Aurora, USA
Madison Lyon, Division of Urology, Department of Surgery, University of Colorado Hospital, Aurora, USA
Nicholas George, Division of Urology, Department of Surgery, University of Colorado Hospital, Aurora, USA
Kailynn DeRonde, Connecticut Children's Medical Center, Hartford, USA; School of Pharmacy, University of Connecticut, Storrs, USA
Michelle Burke, Department of Pharmacy, University of Colorado Hospital, Aurora, USA
Colin O’Donnell, Division of Urology, Department of Surgery, University of Colorado Hospital, Aurora, USA
Clark Lyda, Department of Pharmacy, University of Colorado Hospital, Aurora, USA
Tyree H. Kiser, Department of Clinical Pharmacy, University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences, Aurora, USA
Shandra Wilson, Division of Urology, Department of Surgery, University of Colorado Hospital, Aurora, USA
Follow on us
Alvimopan is a µ-opioid receptor antagonist used in the post-operative period to decrease rates of post-operative ileus (POI) following radical cystectomy (RC) and thereby shorten length of stay (LOS). Naloxegol is a much less expensive drug of the same class that has yet to be studied for prevention of POI in the peri-operative period. The purpose of the current study is to evaluate the differences in LOS and development of POI in patients post-RC who take alvimopan versus those who take naloxegol, with the hope that drug efficacy can be evaluated against the significant difference in cost burden between the two drugs. The study population included all adult patients between 18–89 years of age with bladder cancer undergoing radical cystectomy with urostomy at University of Colorado Hospital. Those patients who received usual post-operative care as well as either alvimopan or naloxegol between September 2011 and December 2017 were selected for analysis. Patients who did not take either medication or were switched from one drug to the other were excluded from the study. A zero-truncated binomial regression analysis was used to analyze differences in length of stay in patients who received alvimopan versus those who received naloxegol. Additionally, the incidence of post-operative ileus was compared between treatment groups. 130 patients who underwent RC and received either alvimopan or naloxegol were included in the study: 75 (58%) received alvimopan and 55 (42%) received naloxegol. Baseline characteristics were similar between treatment groups. There was no significant difference in the length of stay between patients who received alvimopan and patients who received naloxegol after adjusting for age, sex, BMI, length of surgical time, or stage of disease (p = 0.41). There was no significant between the two drugs for development of POI (p = 0.85). Development of POI was significantly associated with a longer LOS (p = 0.007). The analysis showed that naloxegol was comparable to alvimopan when it came to length of hospital stay following RC. Therefore, naloxegol may be offered as a less expensive, effective alternative to alvimopan.
Alvimopan, Naloxegol, Post-operative Ileus, Length of Stay, µ-opioid Receptor Antagonist, Radical Cystectomy
To cite this article
Tyree H. Kiser,
A Retrospective Study of Patients Undergoing Radical Cystectomy and Receiving Peri-Operative Naloxegol or Alvimopan: Comparison of Length of Stay, Journal of Surgery.
Vol. 6, No. 5,
2018, pp. 129-134.
Copyright © 2018 Authors retain the copyright of this article.
This article is an open access article distributed under the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/
) which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Lee, C. T. et al. Alvimopan Accelerates Gastrointestinal Recovery After Radical Cystectomy: A Multicenter Randomized Placebo-Controlled Trial. Eur. Urol. 66, 265–272 (2014).
Kraft, M., MacLaren, R., Du, W. & Owens, G. Alvimopan (Entereg) for the Management Of Postoperative Ileus in Patients Undergoing Bowel Resection. Pharm. Ther. 35, 44–49 (2010).
Delaney, C. P. 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, 1114–1125; discussion 1125–1126; author reply 1127–1129 (2005).
Viscusi, E. R. 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. Surg. Endosc. 20, 64–70 (2006).
Wolff, B. G. 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. 240, 728–734; discussion 734–735 (2004).
Ludwig, K. 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. Chic. Ill 1960 143, 1098–1105 (2008).
Büchler, M. W. et al. Clinical trial: alvimopan for the management of post-operative ileus after abdominal surgery: results of an international randomized, double-blind, multicentre, placebo-controlled clinical study. Aliment. Pharmacol. Ther. 28, 312–325 (2008).
ENTEREG® (alvimopan) | Official Site. Available at: https://www.merckconnect.com/entereg/overview.html. (Accessed: 5th April 2018)
Kauf, T. L. et al. Alvimopan, a Peripherally Acting μ-Opioid Receptor Antagonist, is Associated with Reduced Costs after Radical Cystectomy: Economic Analysis of a Phase 4 Randomized, Controlled Trial. J. Urol. 191, 1721–1727 (2014).
Cui, Y., Chen, H., Qi, L., Zu, X. & Li, Y. Effect of alvimopan on accelerates gastrointestinal recovery after radical cystectomy: A systematic review and meta-analysis. Int. J. Surg. Lond. Engl. 25, 1–6 (2016).
Earnshaw, S. R. et al. Economic Impact of Alvimopan Considering Varying Definitions of Postoperative Ileus. J. Am. Coll. Surg. 221, 941–950 (2015).
Sultan, S., Coles, B. & Dahm, P. Alvimopan for recovery of bowel function after radical cystectomy. Cochrane Database Syst. Rev. 5, CD012111 (2017).
K Dodson, PharmD & Clark Lyda, Pharm D. Average Wholesale Price (AWP) of Alvimopan and Naloxegol. (2018).
MOVANTIK® (naloxegol) | Opioid Induced Constipation Treatment. Available at: https://www.movantik.com/home.html. (Accessed: 5th April 2018)
Nee, J. et al. Efficacy of Treatments for Opioid-induced Constipation: A Systematic Review and Meta-Analysis. Clin. Gastroenterol. Hepatol. Off. Clin. Pract. J. Am. Gastroenterol. Assoc. (2018). doi:10.1016/j.cgh.2018.01.021
Halawi, H. et al. Effects of naloxegol on whole gut transit in opioid-naïve healthy subjects receiving codeine: A randomized, controlled trial. Neurogastroenterol. Motil. Off. J. Eur. Gastrointest. Motil. Soc. (2018). doi:10.1111/nmo.13298
Grønlund, D. et al. The impact of naloxegol on anal sphincter function - Using a human experimental model of opioid-induced bowel dysfunction. Eur. J. Pharm. Sci. Off. J. Eur. Fed. Pharm. Sci. 117, 187–192 (2018).
Manger, J. P. et al. Alvimopan: A cost-effective tool to decrease cystectomy length of stay. Cent. Eur. J. Urol. 67, 335–341 (2014).
Tobis, S. et al. Effect of alvimopan on return of bowel function after robot-assisted radical cystectomy. J. Laparoendosc. Adv. Surg. Tech. A 24, 693–697 (2014).
Vora, A. A. et al. Alvimopan provides rapid gastrointestinal recovery without nasogastric tube decompression after radical cystectomy and urinary diversion. Can. J. Urol. 19, 6293–6298 (2012).
Kim, S. P. et al. Population-based trends in urinary diversion among patients undergoing radical cystectomy for bladder cancer. BJU Int. 112, 478–484 (2013).
Clark, P. E. et al. Radical cystectomy in the elderly: comparison of clincal outcomes between younger and older patients. Cancer 104, 36–43 (2005).
Schmid, M. et al. Evidence from the ‘PROspective MulticEnTer RadIcal Cystectomy Series 2011 (PROMETRICS 2011)’ study: how are preoperative patient characteristics associated with urinary diversion type after radical cystectomy for bladder cancer? Ann. Surg. Oncol. 22, 1032–1042 (2015).