Kappa-opioid system in uremic pruritus: multicenter, randomized, double-blind, placebo-controlled clinical studies.
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.
Wikström
Björn
B
Department of Nephrology, Dialysis Unit, University Hospital, Uppsala, Sweden.
Gellert
Ryszard
R
Ladefoged
Søren D
SD
Danda
Yasuaki
Y
Akai
Masahiko
M
Ide
Kaoru
K
Ogasawara
Midori
M
Kawashima
Yoshiharu
Y
Ueno
Koki
K
Mori
Akio
A
Ueno
Yuji
Y
D000328:Adult; D000368:Aged; D000982:Antipruritics / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007262:Infusions, Intravenous; D007676:Kidney Failure, Chronic / Q000150:complications / Q000175:diagnosis / Q000628:therapy; D007677:Kidney Function Tests; D008297:Male; D008875:Middle Aged; D009271:Naltrexone / Q000627:therapeutic use*; D011336:Probability; D011537:Pruritus / Q000188:drug therapy* / Q000209:etiology* / Q000503:physiopathology; D017473:Receptors, Opioid, kappa / Q000037:antagonists & inhibitors*; D012016:Reference Values; D006435:Renal Dialysis; D018570:Risk Assessment; D012720:Severity of Illness Index; D016896:Treatment Outcome; D014511:Uremia / Q000150:complications* / Q000175:diagnosis / Q000628:therapy
D000982:Antipruritics; D017473:Receptors, Opioid, kappa; D009271:Naltrexone