1. Kappa-opioid system in uremic pruritus: multicenter, randomized, double-blind, placebo-controlled clinical studies
- Author
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Björn Wikström, Koki Ueno, Ryszard Gellert, Yoshiharu Kawashima, Kaoru Ide, Akio Mori, Yuji Ueno, Yasuaki Danda, Masahiko Akai, Søren Ladefoged, and Midori Ogasawara
- Subjects
Adult ,Male ,medicine.medical_specialty ,Uremic pruritus ,Randomization ,medicine.medical_treatment ,Placebo ,Kidney Function Tests ,Gastroenterology ,Risk Assessment ,Severity of Illness Index ,Drug Administration Schedule ,law.invention ,Randomized controlled trial ,Double-Blind Method ,law ,Reference Values ,Renal Dialysis ,Internal medicine ,medicine ,Humans ,skin and connective tissue diseases ,Adverse effect ,Infusions, Intravenous ,Aged ,Probability ,Uremia ,Dose-Response Relationship, Drug ,business.industry ,Pruritus ,Receptors, Opioid, kappa ,General Medicine ,Antipruritics ,Middle Aged ,medicine.disease ,Naltrexone ,Surgery ,Treatment Outcome ,Nephrology ,Itching ,Kidney Failure, Chronic ,Female ,Hemodialysis ,medicine.symptom ,business ,Nalfurafine ,medicine.drug ,Follow-Up Studies - Abstract
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 kappa-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.
- Published
- 2005