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-Opioid System in Uremic Pruritus: Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Studies

Björn Wikström^*, Ryszard Gellert, Søren D. Ladefoged, Yasuaki Danda, Masahiko Akai, Kaoru Ide, Midori Ogasawara, Yoshiharu Kawashima, Koki Ueno, Akio Mori and Yuji Ueno

^* Department of Nephrology, Dialysis Unit, University Hospital, Uppsala, Sweden; Department of Health Care, Institute of Social Medicine, Warsaw Medical University, Warsaw, Poland; Department of Nephrology, Section 5101, Rigshopspitalet, Copenhagen, Denmark; and Clinical Development Center, Toray Industries, Inc., Chiba, Japan

Address correspondence to: Dr. Yuji Ueno, Clinical Development Center, Toray Industries Inc., 8-1, Mihama 1-chome, Urayasu, Chiba 279-8555, Japan. Phone: +81-47-350-6754; Fax: +81-47-350-6769; E-mail: yuji_ueno{at}nts.toray.co.jp

Received for publication February 8, 2005. Accepted for publication September 7, 2005.

Uremic pruritus is a very common and frustrating condition for both patients and clinicians because no treatment has been demonstrated to be effective in relieving the itch. In this report, nalfurafine, a new -opioid receptor agonist, was used to treat uremic pruritus in patients who were undergoing routine hemodialysis. Two multicenter, randomized, double-blind, placebo-controlled studies enrolled 144 patients with uremic pruritus to postdialysis intravenous treatment with either nalfurafine or placebo for 2 to 4 wk. A meta-analysis approach was used to assess the efficacy of nalfurafine. Statistically significant reductions in worst itching (P = 0.0212), itching intensity (P = 0.0410), and sleep disturbances (P = 0.0003) were noted in the nalfurafine group as compared with placebo. Improvements in itching (P = 0.0025) and excoriations (P = 0.0060) were noted for the nalfurafine-treated patients. Nalfurafine showed similar types and incidences of drug-related adverse events as did placebo. Nalfurafine was shown to be an effective and safe compound for use in this severely ill patient population.

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Copyright © 2008 by the American Society of Nephrology. Online ISSN: 1533-3450 Print ISSN: 1046-6673