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Article

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

by
Hiromi Nishiba
1,2,
Hisao Imai
3,4,*,
Yukiyoshi Fujita
5,
Eriko Hiruta
5,
Takashi Masuno
6,
Shigeki Yamazaki
7,
Hajime Tanaka
8,
Teruhiko Kamiya
9,
Masako Ito
10,
Satoshi Takei
11,
Masato Matsuura
12,
Junnosuke Mogi
13,
Koichi Minato
4 and
Kyoko Obayashi
2
1
Division of Pharmacy, Japan Community Health Care Organization (JCHO) Gunma Chuo Hospital, 1-7-13, Kouun, Maebashi 371-0025, Gunma, Japan
2
Graduate School of Pharmaceutical Sciences, Takasaki University of Health and Welfare, 37-1, Nakaorui, Takasaki 370-0033, Gunma, Japan
3
Department of Respiratory Medicine, Comprehensive Cancer Center, International Medical Center, Saitama Medical University, 1397-1, Yamane, Hidaka 350-1298, Saitama, Japan
4
Division of Respiratory Medicine, Gunma Prefectural Cancer Center, 617-1, Takahayashi-nishi, Ota 373-8550, Gunma, Japan
5
Division of Pharmacy, Gunma Prefectural Cancer Center, 617-1, Takahayashi-nishi, Ota 373-8550, Gunma, Japan
6
Division of Pharmacy, Fujioka General Hospital, 813-1, Nakagurisu, Fujioka 375-8503, Gunma, Japan
7
Division of Pharmacy, Kiryu Kosei General Hospital, 6-3, Orihime, Kiryu 376-0024, Gunma, Japan
8
Division of Pharmacy, Haramachi Red Cross Hospital, 698, Haramachi, Higashiagatsuma-machi, Agatsuma-gun 377-0882, Gunma, Japan
9
Department of Pharmacy, Tatebayashi Kosei General Hospital, 262-1, Narushima, Tatebayashi 374-8533, Gunma, Japan
10
Division of Pharmacy, Ota Memorial Hospital, 455-1, Oshima, Ota 373-8585, Gunma, Japan
11
Division of Pharmacy, Tone Central Hospital, 910-1, Numasu, Numata 378-0012, Gunma, Japan
12
Division of Pharmacy, Gunma Saiseikai Maebashi Hospital, 564-1, Kamishinden, Maebashi 371-0821, Gunma, Japan
13
Division of Pharmacy, Hidaka Hospital, 886, Nakao, Takasaki 370-0001, Gunma, Japan
 
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*
Author to whom correspondence should be addressed.
J. Clin. Med. 2022, 11(9), 2672; https://doi.org/10.3390/jcm11092672
Submission received: 15 March 2022 / Revised: 21 April 2022 / Accepted: 5 May 2022 / Published: 9 May 2022
(This article belongs to the Section Gastroenterology & Hepatopancreatobiliary Medicine)
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Abstract

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.
Keywords: clinical practice; efficacy; naldemedine; opioid-induced constipation clinical practice; efficacy; naldemedine; opioid-induced constipation

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MDPI and ACS Style

Nishiba, H.; Imai, H.; Fujita, Y.; Hiruta, E.; Masuno, T.; Yamazaki, S.; Tanaka, H.; Kamiya, T.; Ito, M.; Takei, S.; et al. Efficacy and Safety of Naldemedine for Patients with Cancer with Opioid-Induced Constipation in Clinical Practice: A Real-World Retrospective Study. J. Clin. Med. 2022, 11, 2672. https://doi.org/10.3390/jcm11092672

AMA Style

Nishiba H, Imai H, Fujita Y, Hiruta E, Masuno T, Yamazaki S, Tanaka H, Kamiya T, Ito M, Takei S, et al. Efficacy and Safety of Naldemedine for Patients with Cancer with Opioid-Induced Constipation in Clinical Practice: A Real-World Retrospective Study. Journal of Clinical Medicine. 2022; 11(9):2672. https://doi.org/10.3390/jcm11092672

Chicago/Turabian Style

Nishiba, Hiromi, Hisao Imai, Yukiyoshi Fujita, Eriko Hiruta, Takashi Masuno, Shigeki Yamazaki, Hajime Tanaka, Teruhiko Kamiya, Masako Ito, Satoshi Takei, and et al. 2022. "Efficacy and Safety of Naldemedine for Patients with Cancer with Opioid-Induced Constipation in Clinical Practice: A Real-World Retrospective Study" Journal of Clinical Medicine 11, no. 9: 2672. https://doi.org/10.3390/jcm11092672

APA Style

Nishiba, H., Imai, H., Fujita, Y., Hiruta, E., Masuno, T., Yamazaki, S., Tanaka, H., Kamiya, T., Ito, M., Takei, S., Matsuura, M., Mogi, J., Minato, K., & Obayashi, K. (2022). Efficacy and Safety of Naldemedine for Patients with Cancer with Opioid-Induced Constipation in Clinical Practice: A Real-World Retrospective Study. Journal of Clinical Medicine, 11(9), 2672. https://doi.org/10.3390/jcm11092672

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