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Journal of Pain Research Volume 13, 2020 - Issue
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Original Research

A Renal Impairment Subgroup Analysis of the Safety and Efficacy of Naldemedine for the Treatment of Opioid-Induced Constipation in Patients with Chronic Non-Cancer Pain Receiving Opioid Therapy

Lynn R Webster1 PRA Health Sciences, Salt Lake City, UT, USACorrespondence[email protected]
ORCID Iconhttps://orcid.org/0000-0001-8609-9424View further author information
ORCID Icon,
Martin E Hale2 Gold Coast Research LLC, Plantation, FL, USAView further author information
,
Tadaaki Yamada3 Shionogi, Inc., Florham Park, NJ, USAView further author information
&
James E Wild4 Upstate Clinical Research Associates, Williamsville, NY, USAView further author information
Pages 605-612 | Published online: 24 Mar 2020

References

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  • Camilleri M, Drossman DA, Becker G, Webster LR, Davies AN, Mawe GM. Emerging treatments in neurogastroenterology: a multidisciplinary working group consensus statement on opioid-induced constipation. Neurogastroenterol Motil. 2014;26(10):1386–1395. doi:10.1111/nmo.2014.26.issue-10
  • Coyne KS, Margolis MK, Yeomans K, et al. Opioid-induced constipation among patients with chronic noncancer pain in the United States, Canada, Germany, and the United Kingdom: laxative use, response, and symptom burden over time. Pain Med. 2015;16(8):1551–1565. doi:10.1111/pme.12724
  • Gupta S, Patel H, Scopel J, Mody RR. Impact of constipation on opioid therapy management among long-term opioid users, based on a patient survey. J Opioid Manag. 2015;11(4):325–338. doi:10.5055/jom.2015.0282
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  • European Medicines Agency. Rizmoic (naldemedine); 2019. Available from: https://www.ema.europa.eu/en/medicines/human/EPAR/rizmoic. Accessed January 17, 2020.
  • Hale M, Wild J, Reddy J, Yamada T, Arjona Ferreira JC. Naldemedine versus placebo for opioid-induced constipation (COMPOSE-1 and COMPOSE-2): two multicentre, phase 3, double-blind, randomised, parallel-group trials. Lancet Gastroenterol Hepatol. 2017;2(8):555–564. doi:10.1016/S2468-1253(17)30105-X
  • Webster LR, Nalamachu S, Morlion B, et al. Long-term use of naldemedine in the treatment of opioid-induced constipation in patients with chronic non-cancer pain: a randomized, double-blind, placebo-controlled phase 3 study. Pain. 2018;159(5):987–994. doi:10.1097/j.pain.0000000000001174
  • United States Renal Data System. 2018 annual data report highlights. 2018. Available from: https://www.usrds.org/adrhighlights.aspx. Accessed February 7, 2020.
  • Munar MY, Singh H. Drug dosing adjustments in patients with chronic kidney disease. Am Fam Physician. 2007;75(10):1487–1496.
  • Smith BS, Yogaratnam D, Levasseur-Franklin KE, Forni A, Fong J. Introduction to drug pharmacokinetics in the critically ill patient. Chest. 2012;141(5):1327–1336. doi:10.1378/chest.11-1396
  • Movantik [Package Insert]. Wilmington, DE: AstraZeneca Pharmaceuticals; 2018.
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