Long-term efficacy and safety of nalfurafine hydrochloride on pruritus in chronic liver disease patients: Patient-reported outcome based analyses

• Published in: PloS one 2017-06, Vol.12 (6), p.e0178991
• Main Authors: Kamimura, Kenya, Yokoo, Takeshi, Kamimura, Hiroteru, Sakamaki, Akira, Abe, Satoshi, Tsuchiya, Atsunori, Takamura, Masaaki, Kawai, Hirokazu, Yamagiwa, Satoshi, Terai, Shuji
• Format: Article
• Language: English
• Subjects: Adult; Aged; Aged, 80 and over; Analysis; Anemia; Antipruritics; Antipruritics - administration & dosage; Antipruritics - adverse effects; Antipruritics - therapeutic use; Biochemistry; Biology and Life Sciences; Chronic Disease; Clinical outcomes; Complications and side effects; Continuous improvement; Dosage and administration; Drug therapy; Drugs; Effectiveness; Female; Gallbladder diseases; Gastroenterology; Hemodialysis; Hepatology; Humans; Inventories; Itching; Liver; Liver diseases; Liver Diseases - complications; Liver Diseases - diagnosis; Liver Diseases - etiology; Male; Medicine and Health Sciences; Middle Aged; Morphinans - administration & dosage; Morphinans - adverse effects; Morphinans - therapeutic use; Narcotics; Opioid receptors (type kappa); Opioid receptors (type mu); Oral administration; Oral cavity; Patient Reported Outcome Measures; Patients; Pruritus; Pruritus - drug therapy; Pruritus - etiology; Psychological stress; Quality of Life; Questionnaires; Risk factors; Safety; Safety and security measures; Social Sciences; Spiro Compounds - administration & dosage; Spiro Compounds - adverse effects; Spiro Compounds - therapeutic use; Stresses; Surveys and Questionnaires; Toxicity; Treatment Outcome; Values; Visual perception
• ISSN: 1932-6203; 1932-6203
• DOI: 10.1371/journal.pone.0178991

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. 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. A 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. Pruritus 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. Nalfurafine hydrochloride contributed to long-term suppression of pruritus without significant safety problems.