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Efficacy and Safety of Naldemedine for Patients with Cancer with Opioid-Induced Constipation in Clinical Practice: A Real-World Retrospective Study

The efficacy and safety of naldemedine for opioid-induced constipation in patients with cancer has not been investigated in clinical practice. We conducted a multicenter, retrospective study to assess the effects of naldemedine among 10 Japanese institutions between June 2017 and August 2019. We eva...

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Autores principales: Nishiba, Hiromi, Imai, Hisao, Fujita, Yukiyoshi, Hiruta, Eriko, Masuno, Takashi, Yamazaki, Shigeki, Tanaka, Hajime, Kamiya, Teruhiko, Ito, Masako, Takei, Satoshi, Matsuura, Masato, Mogi, Junnosuke, Minato, Koichi, Obayashi, Kyoko
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9102706/
https://www.ncbi.nlm.nih.gov/pubmed/35566798
http://dx.doi.org/10.3390/jcm11092672
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author Nishiba, Hiromi
Imai, Hisao
Fujita, Yukiyoshi
Hiruta, Eriko
Masuno, Takashi
Yamazaki, Shigeki
Tanaka, Hajime
Kamiya, Teruhiko
Ito, Masako
Takei, Satoshi
Matsuura, Masato
Mogi, Junnosuke
Minato, Koichi
Obayashi, Kyoko
author_facet Nishiba, Hiromi
Imai, Hisao
Fujita, Yukiyoshi
Hiruta, Eriko
Masuno, Takashi
Yamazaki, Shigeki
Tanaka, Hajime
Kamiya, Teruhiko
Ito, Masako
Takei, Satoshi
Matsuura, Masato
Mogi, Junnosuke
Minato, Koichi
Obayashi, Kyoko
author_sort Nishiba, Hiromi
collection PubMed
description The efficacy and safety of naldemedine for opioid-induced constipation in patients with cancer has not been investigated in clinical practice. We conducted a multicenter, retrospective study to assess the effects of naldemedine among 10 Japanese institutions between June 2017 and August 2019. We evaluated the number of defecations 7 days before and after naldemedine administration. A total of 149 patients (89 male) with a median age of 72 years (range, 38–96) were included. The performance status was 0–1, 2, and ≥3 in 40, 38, and 71 patients, respectively. The median opioid dose in oral morphine equivalents was 30 mg/day (range: 7.5–800 mg). We observed 98 responders and 51 non-responders. The median number of defecations increased significantly in the 7 days following naldemedine administration from three to six (p < 0.0001). Multivariate analysis revealed that an opioid dose <30 mg/day [odds ratio, 2.08; 95% confidence interval, 1.01–4.32; p = 0.042] was significantly correlated with the effect of naldemedine. Diarrhea was the most common adverse event (38.2%) among all grades. The efficacy and safety of naldemedine in clinical practice are comparable to those of prospective studies, suggesting that it is effective in most patients.
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spelling pubmed-91027062022-05-14 Efficacy and Safety of Naldemedine for Patients with Cancer with Opioid-Induced Constipation in Clinical Practice: A Real-World Retrospective Study Nishiba, Hiromi Imai, Hisao Fujita, Yukiyoshi Hiruta, Eriko Masuno, Takashi Yamazaki, Shigeki Tanaka, Hajime Kamiya, Teruhiko Ito, Masako Takei, Satoshi Matsuura, Masato Mogi, Junnosuke Minato, Koichi Obayashi, Kyoko J Clin Med Article The efficacy and safety of naldemedine for opioid-induced constipation in patients with cancer has not been investigated in clinical practice. We conducted a multicenter, retrospective study to assess the effects of naldemedine among 10 Japanese institutions between June 2017 and August 2019. We evaluated the number of defecations 7 days before and after naldemedine administration. A total of 149 patients (89 male) with a median age of 72 years (range, 38–96) were included. The performance status was 0–1, 2, and ≥3 in 40, 38, and 71 patients, respectively. The median opioid dose in oral morphine equivalents was 30 mg/day (range: 7.5–800 mg). We observed 98 responders and 51 non-responders. The median number of defecations increased significantly in the 7 days following naldemedine administration from three to six (p < 0.0001). Multivariate analysis revealed that an opioid dose <30 mg/day [odds ratio, 2.08; 95% confidence interval, 1.01–4.32; p = 0.042] was significantly correlated with the effect of naldemedine. Diarrhea was the most common adverse event (38.2%) among all grades. The efficacy and safety of naldemedine in clinical practice are comparable to those of prospective studies, suggesting that it is effective in most patients. MDPI 2022-05-09 /pmc/articles/PMC9102706/ /pubmed/35566798 http://dx.doi.org/10.3390/jcm11092672 Text en © 2022 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Nishiba, Hiromi
Imai, Hisao
Fujita, Yukiyoshi
Hiruta, Eriko
Masuno, Takashi
Yamazaki, Shigeki
Tanaka, Hajime
Kamiya, Teruhiko
Ito, Masako
Takei, Satoshi
Matsuura, Masato
Mogi, Junnosuke
Minato, Koichi
Obayashi, Kyoko
Efficacy and Safety of Naldemedine for Patients with Cancer with Opioid-Induced Constipation in Clinical Practice: A Real-World Retrospective Study
title Efficacy and Safety of Naldemedine for Patients with Cancer with Opioid-Induced Constipation in Clinical Practice: A Real-World Retrospective Study
title_full Efficacy and Safety of Naldemedine for Patients with Cancer with Opioid-Induced Constipation in Clinical Practice: A Real-World Retrospective Study
title_fullStr Efficacy and Safety of Naldemedine for Patients with Cancer with Opioid-Induced Constipation in Clinical Practice: A Real-World Retrospective Study
title_full_unstemmed Efficacy and Safety of Naldemedine for Patients with Cancer with Opioid-Induced Constipation in Clinical Practice: A Real-World Retrospective Study
title_short Efficacy and Safety of Naldemedine for Patients with Cancer with Opioid-Induced Constipation in Clinical Practice: A Real-World Retrospective Study
title_sort efficacy and safety of naldemedine for patients with cancer with opioid-induced constipation in clinical practice: a real-world retrospective study
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9102706/
https://www.ncbi.nlm.nih.gov/pubmed/35566798
http://dx.doi.org/10.3390/jcm11092672
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