Real-World Patient Characteristics and Treatment Patterns of Naldemedine for the Treatment of Opioid-Induced Constipation in Patients with Cancer: A Multicenter Retrospective Chart Review Study

<i>Background and Objectives</i>: Naldemedine is a peripherally acting μ-opioid receptor antagonist that improves opioid-induced constipation. Although clinical trials have excluded patients with poor performance status (PS) and those started on naldemedine early after opioid initiation,...

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Autores principales:	Eriko Hiruta, Yukiyoshi Fujita, Hisao Imai, Takashi Masuno, Shigeki Yamazaki, Hajime Tanaka, Teruhiko Kamiya, Masako Ito, Satoshi Takei, Masato Matsuura, Hiromi Nishiba, Junnosuke Mogi, Mie Kotake, Shiro Koizuka, Koichi Minato
Formato:	article
Lenguaje:	EN
Publicado:	MDPI AG 2021
Materias:	naldemedine opioid-induced constipation performance status real-world data treatment patterns Medicine (General) R5-920
Acceso en línea:	https://doaj.org/article/9baf8d2664d2432e9483df6b1bc9fe63
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spelling	oai:doaj.org-article:9baf8d2664d2432e9483df6b1bc9fe632021-11-25T18:18:49ZReal-World Patient Characteristics and Treatment Patterns of Naldemedine for the Treatment of Opioid-Induced Constipation in Patients with Cancer: A Multicenter Retrospective Chart Review Study10.3390/medicina571112331648-91441010-660Xhttps://doaj.org/article/9baf8d2664d2432e9483df6b1bc9fe632021-11-01T00:00:00Zhttps://www.mdpi.com/1648-9144/57/11/1233https://doaj.org/toc/1010-660Xhttps://doaj.org/toc/1648-9144<i>Background and Objectives</i>: Naldemedine is a peripherally acting μ-opioid receptor antagonist that improves opioid-induced constipation. Although clinical trials have excluded patients with poor performance status (PS) and those started on naldemedine early after opioid initiation, clinical practice has used naldemedine for the same patients. Therefore, we investigated the treatment patterns of naldemedine in a real-world setting. <i>Materials and Methods</i>: This was a multicenter, retrospective chart review study of opioid-treated patients with cancer receiving naldemedine. Adverse events that occurred within 7 days of naldemedine initiation were evaluated in those who received one or more doses of the same. Effectiveness was assessed in patients who used naldemedine for more than 7 days. <i>Results</i>: A total of 296 patients satisfied the eligibility criteria, among whom 129 (43.6%) had a PS of ≥3 and 176 (59.5%) started naldemedine within 2 weeks of opioid initiation. Moreover, 203 (79.6%) patients had ≥3 bowel movements per week. Incidences of all grades of diarrhea and abdominal pain were 87 (29.4%) and 12 (4.1%), respectively. No patient had grade 4 or higher adverse events. <i>Conclusions</i>: Although nearly half of the patients receiving naldemedine in clinical practice belonged to populations that were not included in the clinical trials, our results suggested that naldemedine in clinical practice had the same efficacy and safety as that in clinical trials.Eriko HirutaYukiyoshi FujitaHisao ImaiTakashi MasunoShigeki YamazakiHajime TanakaTeruhiko KamiyaMasako ItoSatoshi TakeiMasato MatsuuraHiromi NishibaJunnosuke MogiMie KotakeShiro KoizukaKoichi MinatoMDPI AGarticlenaldemedineopioid-induced constipationperformance statusreal-world datatreatment patternsMedicine (General)R5-920ENMedicina, Vol 57, Iss 1233, p 1233 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	naldemedine opioid-induced constipation performance status real-world data treatment patterns Medicine (General) R5-920
spellingShingle	naldemedine opioid-induced constipation performance status real-world data treatment patterns Medicine (General) R5-920 Eriko Hiruta Yukiyoshi Fujita Hisao Imai Takashi Masuno Shigeki Yamazaki Hajime Tanaka Teruhiko Kamiya Masako Ito Satoshi Takei Masato Matsuura Hiromi Nishiba Junnosuke Mogi Mie Kotake Shiro Koizuka Koichi Minato Real-World Patient Characteristics and Treatment Patterns of Naldemedine for the Treatment of Opioid-Induced Constipation in Patients with Cancer: A Multicenter Retrospective Chart Review Study
description	<i>Background and Objectives</i>: Naldemedine is a peripherally acting μ-opioid receptor antagonist that improves opioid-induced constipation. Although clinical trials have excluded patients with poor performance status (PS) and those started on naldemedine early after opioid initiation, clinical practice has used naldemedine for the same patients. Therefore, we investigated the treatment patterns of naldemedine in a real-world setting. <i>Materials and Methods</i>: This was a multicenter, retrospective chart review study of opioid-treated patients with cancer receiving naldemedine. Adverse events that occurred within 7 days of naldemedine initiation were evaluated in those who received one or more doses of the same. Effectiveness was assessed in patients who used naldemedine for more than 7 days. <i>Results</i>: A total of 296 patients satisfied the eligibility criteria, among whom 129 (43.6%) had a PS of ≥3 and 176 (59.5%) started naldemedine within 2 weeks of opioid initiation. Moreover, 203 (79.6%) patients had ≥3 bowel movements per week. Incidences of all grades of diarrhea and abdominal pain were 87 (29.4%) and 12 (4.1%), respectively. No patient had grade 4 or higher adverse events. <i>Conclusions</i>: Although nearly half of the patients receiving naldemedine in clinical practice belonged to populations that were not included in the clinical trials, our results suggested that naldemedine in clinical practice had the same efficacy and safety as that in clinical trials.
format	article
author	Eriko Hiruta Yukiyoshi Fujita Hisao Imai Takashi Masuno Shigeki Yamazaki Hajime Tanaka Teruhiko Kamiya Masako Ito Satoshi Takei Masato Matsuura Hiromi Nishiba Junnosuke Mogi Mie Kotake Shiro Koizuka Koichi Minato
author_facet	Eriko Hiruta Yukiyoshi Fujita Hisao Imai Takashi Masuno Shigeki Yamazaki Hajime Tanaka Teruhiko Kamiya Masako Ito Satoshi Takei Masato Matsuura Hiromi Nishiba Junnosuke Mogi Mie Kotake Shiro Koizuka Koichi Minato
author_sort	Eriko Hiruta
title	Real-World Patient Characteristics and Treatment Patterns of Naldemedine for the Treatment of Opioid-Induced Constipation in Patients with Cancer: A Multicenter Retrospective Chart Review Study
title_short	Real-World Patient Characteristics and Treatment Patterns of Naldemedine for the Treatment of Opioid-Induced Constipation in Patients with Cancer: A Multicenter Retrospective Chart Review Study
title_full	Real-World Patient Characteristics and Treatment Patterns of Naldemedine for the Treatment of Opioid-Induced Constipation in Patients with Cancer: A Multicenter Retrospective Chart Review Study
title_fullStr	Real-World Patient Characteristics and Treatment Patterns of Naldemedine for the Treatment of Opioid-Induced Constipation in Patients with Cancer: A Multicenter Retrospective Chart Review Study
title_full_unstemmed	Real-World Patient Characteristics and Treatment Patterns of Naldemedine for the Treatment of Opioid-Induced Constipation in Patients with Cancer: A Multicenter Retrospective Chart Review Study
title_sort	real-world patient characteristics and treatment patterns of naldemedine for the treatment of opioid-induced constipation in patients with cancer: a multicenter retrospective chart review study
publisher	MDPI AG
publishDate	2021
url	https://doaj.org/article/9baf8d2664d2432e9483df6b1bc9fe63
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Real-World Patient Characteristics and Treatment Patterns of Naldemedine for the Treatment of Opioid-Induced Constipation in Patients with Cancer: A Multicenter Retrospective Chart Review Study

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