Efficacy of nalfurafine hydrochloride in patients with chronic liver disease with refractory pruritus

A randomized, double-blind trial

Hiromitsu Kumada, Hiroshi Miyakawa, Taro Muramatsu, Naoki Ando, Takanori Oh, Kenji Takamori, Hidetomo Nakamoto

Research output: Contribution to journalArticle

23 Citations (Scopus)

Abstract

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.

Original languageEnglish
Pages (from-to)972-982
Number of pages11
JournalHepatology Research
Volume47
Issue number10
DOIs
Publication statusPublished - 2017 Sep 1

Fingerprint

Pruritus
Liver Diseases
Chronic Disease
Drug-Related Side Effects and Adverse Reactions
Placebos
Sleep Initiation and Maintenance Disorders
Visual Analog Scale
Nocturia
Cholestasis
Opioid Receptors
Constipation
TRK 820
Sleep
Observation

Keywords

  • chronic liver disease
  • double-blind
  • nalfurafine hydrochloride
  • pruritus
  • VAS
  • κ-opioid receptor agonist

ASJC Scopus subject areas

  • Hepatology
  • Infectious Diseases

Cite this

Efficacy of nalfurafine hydrochloride in patients with chronic liver disease with refractory pruritus : A randomized, double-blind trial. / Kumada, Hiromitsu; Miyakawa, Hiroshi; Muramatsu, Taro; Ando, Naoki; Oh, Takanori; Takamori, Kenji; Nakamoto, Hidetomo.

In: Hepatology Research, Vol. 47, No. 10, 01.09.2017, p. 972-982.

Research output: Contribution to journalArticle

Kumada, Hiromitsu ; Miyakawa, Hiroshi ; Muramatsu, Taro ; Ando, Naoki ; Oh, Takanori ; Takamori, Kenji ; Nakamoto, Hidetomo. / Efficacy of nalfurafine hydrochloride in patients with chronic liver disease with refractory pruritus : A randomized, double-blind trial. In: Hepatology Research. 2017 ; Vol. 47, No. 10. pp. 972-982.
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