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Efficacy of nalfurafine hydrochloride in patients with chronic liver disease with refractory pruritus: A randomized, double‐blind trial
Author(s) -
Kumada Hiromitsu,
Miyakawa Hiroshi,
Muramatsu Taro,
Ando Naoki,
Oh Takanori,
Takamori Kenji,
Nakamoto Hidetomo
Publication year - 2017
Publication title -
hepatology research
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.123
H-Index - 75
eISSN - 1872-034X
pISSN - 1386-6346
DOI - 10.1111/hepr.12830
Subject(s) - medicine , placebo , visual analogue scale , refractory (planetary science) , gastroenterology , constipation , somnolence , adverse effect , nocturia , anesthesia , pathology , physics , alternative medicine , astrobiology , urinary system
Aims Patients with chronic liver disease sometimes develop cholestasis, which induces severe whole‐body pruritus that may disrupt daily activities and sleep. To determine the efficacy of nalfurafine hydrochloride (5 μg), which is a selective κ‐opioid receptor agonist, in improving pruritus, we undertook a double‐blind placebo‐controlled study in patients with chronic liver disease with refractory pruritus. Nalfurafine hydrochloride at 2.5 μg was also used to evaluate the dose–response relationship. Methods In total, 318 subjects were randomly assigned to receive the placebo or nalfurafine hydrochloride (2.5 or 5 μg) given orally once daily for 84 consecutive days. Pruritus was assessed based on the visual analog scale and pruritus scores. Results Changes in the visual analog scale at week 4 (last observation carried forward) were significantly greater in the nalfurafine hydrochloride groups at 28.56 and 27.46 mm in the 2.5 μg and 5 μg groups, respectively, compared to 19.25 mm in the placebo group ( P = 0.0022 and 0.0056, respectively). The major adverse drug reactions (ADRs) included pollakiuria (including nocturia), somnolence, insomnia (including middle insomnia), and constipation. Most ADRs were mild. Conclusions Nalfurafine hydrochloride (2.5 or 5 μg daily) was effective in the treatment of refractory pruritus in patients with chronic liver disease. Furthermore, no clinically significant ADRs were observed at either dose.