Post-marketing surveillance study of the safety and efficacy of nalfurafine hydrochloride (Remitch® capsules 2.5 μg) in 3,762 hemodialysis patients with intractable pruritus
Authors Kozono H, Yoshitani H, Nakano R
Received 7 July 2017
Accepted for publication 17 October 2017
Published 15 January 2018 Volume 2018:11 Pages 9—24
Checked for plagiarism Yes
Review by Single-blind
Peer reviewers approved by Dr Amy Norman
Peer reviewer comments 2
Editor who approved publication: Professor Pravin Singhal
Hideki Kozono,* Hiroshi Yoshitani,* Ryoko Nakano*
Pharmaceutical and Medical Device Vigilance Department, Toray Industries, Inc., Tokyo, Japan
*The authors contributed equally to this work
Background: Intractable pruritus in hemodialysis patients can significantly decrease their quality of life and is also associated with poor vital prognosis. Although combined multiple causes of intractable pruritus in these patients have been identified, no existing treatments are proven to be sufficiently effective. We conducted a post-marketing surveillance to follow-up and assess the safety and efficacy of nalfurafine, a selective κ-opioid receptor agonist, for the treatment of intractable pruritus in patients undergoing hemodialysis.
Patients and methods: Hemodialysis patients with intractable pruritus from institutions in Japan who received oral nalfurafine hydrochloride between January 2010 and December 2013 were enrolled in the surveillance. Surveillance was completed in July 2015. Safety data during 1 year after nalfurafine treatment onset, and efficacy data of nalfurafine evaluating the first 12-week treatment period and the following period until 1 year after the initial dose of nalfurafine (using global assessment of the itch improvement by the physician, Visual Analog Scale, and the Shiratori’s severity scores) were collected and analyzed.
Results: In total, 3,762 patients were analyzed for safety. Adverse drug reactions were experienced by 402/3,762 (10.69%) patients. The most frequent adverse drug reactions were insomnia (127/3,762 [3.38%] patients), constipation (34 [0.90%]), somnolence (32 [0.85%]), dizziness (23 [0.61%]), nausea (13 [0.35%]), and malaise (9 [0.24%]). No patients developed dependence on nalfurafine. Nalfurafine was effective in 82.50% (2,880/3,491) of patients during the first 12 weeks and in 84.95% (2,167/2,551) on treatment during the subsequent period until 1 year after nalfurafine treatment initiation. Statistically significant decreases were reported in the Visual Analog Scale and the Shiratori’s severity scores (p<0.001).
Conclusion: Oral nalfurafine hydrochloride (from 2.5 μg/day to a maximum of 5.0 μg/day) continues to be safe and effective for the treatment of intractable pruritus in hemodialysis patients in real-world clinical settings.
Keywords: post-marketing surveillance, safety, efficacy, nalfurafine hydrochloride, pruritus, hemodialysis
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