Post-Marketing Surveillance Study of the Safety and Efficacy of Nalfurafine (Capsules 2.5 μg, Oral Dispersing Tablets 2.5 μg) in 1186 Patients with Chronic Liver Disease and Intractable Pruritus

IF 2.6 Q2 GASTROENTEROLOGY & HEPATOLOGY

Hepatic Medicine : Evidence and Research Pub Date : 2022-05-01 DOI:10.2147/HMER.S352775

H. Yoshitani, Junko Ito, H. Kozono

{"title":"Post-Marketing Surveillance Study of the Safety and Efficacy of Nalfurafine (Capsules 2.5 μg, Oral Dispersing Tablets 2.5 μg) in 1186 Patients with Chronic Liver Disease and Intractable Pruritus","authors":"H. Yoshitani, Junko Ito, H. Kozono","doi":"10.2147/HMER.S352775","DOIUrl":null,"url":null,"abstract":"Background Nalfurafine (Remitch®, Toray Industries, Inc.) is a selective κ-receptor agonist approved in Japan for the improvement of pruritus in patients with chronic liver diseases (only when existing treatments bring insufficient efficacy) in May 2015. Methods A post-marketing Specific Drug Use Survey was conducted in Japan (March 1, 2016 to June 30, 2020) of the safety and efficacy of nalfurafine for the improvement of pruritus in patients with chronic liver disease. Results Among 1186 cases analyzed for safety, the incidence of adverse drug reactions was 9.4% (112/1186 cases), lower than 61.4% reported in pre-marketing surveillance (297/484 cases). No specific safety issues were found and no cases of concern for drug dependence identified. Efficacy (itch improvement) was demonstrated in 73.16% (815/1114 cases; 12-week analysis set) and in 85.67% (520/607; general assessment of itch improvement at 1-year analysis set). A significant difference was found in 4 items of itch improvement at 12 weeks and 8 items of itch improvement at 1 year. No noteworthy issues were identified. Mean Visual Analog Scale (VAS) values after 12 weeks and 1 year after the first dose were significantly lower than the baseline (p < 0.0001 for both treatment durations). Mean severity scores (Kawashima’s classification scheme) were significantly lower than the pretreatment score at 12 weeks and 1 year after the first dose (both p < 0.0001). No concerns were identified in the efficacy and safety of nalfurafine in patients with specific background, ie, the elderly (aged ≥ 65 years), those with renal impairment, and those on long-term treatment (≥ 365 days) compared with patients without corresponding background. Conclusion No new safety issues of concern or cases of insufficient efficacy were identified in this Specific Drug Use Survey of the safety and efficacy of nalfurafine for the improvement of pruritus in patients with chronic liver diseases.","PeriodicalId":12917,"journal":{"name":"Hepatic Medicine : Evidence and Research","volume":"14 1","pages":"37 - 66"},"PeriodicalIF":2.6000,"publicationDate":"2022-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Hepatic Medicine : Evidence and Research","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.2147/HMER.S352775","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"GASTROENTEROLOGY & HEPATOLOGY","Score":null,"Total":0}

引用次数: 0

Abstract

Background Nalfurafine (Remitch®, Toray Industries, Inc.) is a selective κ-receptor agonist approved in Japan for the improvement of pruritus in patients with chronic liver diseases (only when existing treatments bring insufficient efficacy) in May 2015. Methods A post-marketing Specific Drug Use Survey was conducted in Japan (March 1, 2016 to June 30, 2020) of the safety and efficacy of nalfurafine for the improvement of pruritus in patients with chronic liver disease. Results Among 1186 cases analyzed for safety, the incidence of adverse drug reactions was 9.4% (112/1186 cases), lower than 61.4% reported in pre-marketing surveillance (297/484 cases). No specific safety issues were found and no cases of concern for drug dependence identified. Efficacy (itch improvement) was demonstrated in 73.16% (815/1114 cases; 12-week analysis set) and in 85.67% (520/607; general assessment of itch improvement at 1-year analysis set). A significant difference was found in 4 items of itch improvement at 12 weeks and 8 items of itch improvement at 1 year. No noteworthy issues were identified. Mean Visual Analog Scale (VAS) values after 12 weeks and 1 year after the first dose were significantly lower than the baseline (p < 0.0001 for both treatment durations). Mean severity scores (Kawashima’s classification scheme) were significantly lower than the pretreatment score at 12 weeks and 1 year after the first dose (both p < 0.0001). No concerns were identified in the efficacy and safety of nalfurafine in patients with specific background, ie, the elderly (aged ≥ 65 years), those with renal impairment, and those on long-term treatment (≥ 365 days) compared with patients without corresponding background. Conclusion No new safety issues of concern or cases of insufficient efficacy were identified in this Specific Drug Use Survey of the safety and efficacy of nalfurafine for the improvement of pruritus in patients with chronic liver diseases.

查看原文本刊更多论文

呋喃西林（胶囊2.5μg，口服分散片2.5μg）治疗1186例慢性肝病和顽固性瘙痒患者的上市后安全性和有效性监测研究

背景那曲芬（Remitch®，Toray Industries，股份有限公司）是一种选择性κ-受体激动剂，于2015年5月在日本获得批准，用于改善慢性肝病患者的瘙痒（仅当现有治疗效果不足时）。方法在日本（2016年3月1日至2020年6月30日）进行了一项上市后特定药物使用调查，了解纳呋胺改善慢性肝病患者瘙痒的安全性和有效性。结果在1186例安全性分析病例中，药物不良反应发生率为9.4%（112/1186例），低于上市前监测报告的61.4%（297/484例）。没有发现具体的安全问题，也没有发现任何令人担忧的药物依赖病例。疗效（瘙痒改善）在73.16%（815/1114例；12周分析集）和85.67%（520/607例；在1年分析集对瘙痒改善进行总体评估）中得到证实。12周时瘙痒改善4项，1年时瘙痒改善8项，差异有统计学意义。没有发现任何值得注意的问题。第一次给药后12周和1年的平均视觉模拟量表（VAS）值显著低于基线（两种治疗持续时间均<0.0001）。第一次给药后12周和1年，平均严重程度评分（Kawashima分类方案）显著低于预处理评分（均<0.0001）。在有特定背景的患者中，即老年人（年龄≥65岁）、肾功能损害患者、，以及那些长期治疗（≥365天）的患者与没有相应背景的患者相比。结论在本次针对呋喃西林治疗慢性肝病患者瘙痒的安全性和有效性的专项用药调查中，没有发现新的安全性问题或疗效不足的情况。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

Hepatic Medicine : Evidence and Research GASTROENTEROLOGY & HEPATOLOGY-

自引率

0.00%

发文量

审稿时长

16 weeks

期刊介绍： Hepatic Medicine: Evidence and Research is an international, peer-reviewed, open access, online journal. Publishing original research, reports, editorials, reviews and commentaries on all aspects of adult and pediatric hepatology in the clinic and laboratory including the following topics: Pathology, pathophysiology of hepatic disease Investigation and treatment of hepatic disease Pharmacology of drugs used for the treatment of hepatic disease Although the main focus of the journal is to publish research and clinical results in humans; preclinical, animal and in vitro studies will be published where they will shed light on disease processes and potential new therapies. Issues of patient safety and quality of care will also be considered. As of 1st April 2019, Hepatic Medicine: Evidence and Research will no longer consider meta-analyses for publication.