Abstract
Background and aimAmong various symptoms accompanied with chronic liver disease, pruritus affects the quality of life of patients, causing physical and mental stress, and worsens hepatic function. Recently, κ-opioid receptor agonist, nalfurafine hydrochloride was approved to treat central pruritus in patients with liver disease in Japan. This study aimed to assess the long-term efficacy and safety of nalfurafine hydrochloride on pruritus in chronic liver disease patients.MethodsA patient-reported outcome using questionnaire-based methods was used for 41 liver disease patients with or without pruritus symptoms. Nalfurafine hydrochloride (2.5 μg/day) was orally administered to 18 patients suffering from pruritus symptoms and whose current treatment was not effective. The same questionnaires and visual analogue scales (VAS) were repeatedly followed up for the patients for the entire follow-up period, and biochemical analyses were performed to evaluate the safety of the treatment.ResultsPruritus completely disappeared in seven of 18 cases, and VAS scores showed a decreasing trend over time from the start of nalfurafine hydrochloride administration in all patients who received the medication. Among 11 patients who were followed up for more than 12 weeks, nine patients showed continuous improvement of symptoms, and this progress was still apparent at ≥20 weeks after starting administration (p < 0.0001). The medication was discontinued in four patients because of progression of primary disease, high cost, oral dryness, and anemia. No significant toxicity was observed on the serum biochemical analyses.ConclusionsNalfurafine hydrochloride contributed to long-term suppression of pruritus without significant safety problems.
Highlights
Many cases of chronic liver disease are accompanied by pruritus caused by cholestasis, which cause systemic itching without any skin lesions
Among various symptoms accompanied with chronic liver disease, pruritus affects the quality of life of patients, causing physical and mental stress, and worsens hepatic function
Because the same mechanisms are involved in liver disease-related itching which affect their QOL [4,5,6,7], the administration of nalfurafine hydrochloride in chronic liver disease patients has recently been approved in Japan based on a randomized, double-blind trial assessing the efficacy of nalfurafine hydrochloride in patients with liver disease [8]
Summary
Many cases of chronic liver disease are accompanied by pruritus caused by cholestasis, which cause systemic itching without any skin lesions The symptoms cause both physical and mental stress and affect the quality life (QOL) of the patients. Pruritus has been seen and extensively studied in hemodialysis patients [1] and recently, therapeutic effect of κ-opioid receptor agonist, nalfurafine hydrochloride, on the itching by modulating the central nervous signals, have been reported in the hemodialysis patients [2, 3]. In terms of long-term efficacy of nalfurafine hydrochloride, Kumagai H et al reported that time-dependent improvement of symptoms assessed by VAS was seen for 1 year of observation, and long-term suppression of pruritus was evidenced in their clinical study for patients on hemodialysis [2]; no studies of nalfurafine hydrochloride in patients with liver disease have been reported to date. This study aimed to assess the long-term efficacy and safety of nalfurafine hydrochloride on pruritus in chronic liver disease patients
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