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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
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 suffi...
Autores principales: | , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Dove Medical Press
2018
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5774492/ https://www.ncbi.nlm.nih.gov/pubmed/29391822 http://dx.doi.org/10.2147/IJNRD.S145720 |
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author | Kozono, Hideki Yoshitani, Hiroshi Nakano, Ryoko |
author_facet | Kozono, Hideki Yoshitani, Hiroshi Nakano, Ryoko |
author_sort | Kozono, Hideki |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-5774492 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2018 |
publisher | Dove Medical Press |
record_format | MEDLINE/PubMed |
spelling | pubmed-57744922018-02-01 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 Kozono, Hideki Yoshitani, Hiroshi Nakano, Ryoko Int J Nephrol Renovasc Dis Original Research 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. Dove Medical Press 2018-01-15 /pmc/articles/PMC5774492/ /pubmed/29391822 http://dx.doi.org/10.2147/IJNRD.S145720 Text en © 2018 Kozono et al. This work is published and licensed by Dove Medical Press Limited The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License (http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. |
spellingShingle | Original Research Kozono, Hideki Yoshitani, Hiroshi Nakano, Ryoko 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 |
title | 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 |
title_full | 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 |
title_fullStr | 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 |
title_full_unstemmed | 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 |
title_short | 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 |
title_sort | 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 |
topic | Original Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5774492/ https://www.ncbi.nlm.nih.gov/pubmed/29391822 http://dx.doi.org/10.2147/IJNRD.S145720 |
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