{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,11,2]],"date-time":"2025-11-02T02:21:29Z","timestamp":1762050089098,"version":"build-2065373602"},"reference-count":21,"publisher":"MDPI AG","issue":"9","license":[{"start":{"date-parts":[[2022,5,9]],"date-time":"2022-05-09T00:00:00Z","timestamp":1652054400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JCM"],"abstract":"<jats:p>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\u201396) were included. The performance status was 0\u20131, 2, and \u22653 in 40, 38, and 71 patients, respectively. The median opioid dose in oral morphine equivalents was 30 mg\/day (range: 7.5\u2013800 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 &lt; 0.0001). Multivariate analysis revealed that an opioid dose &lt;30 mg\/day [odds ratio, 2.08; 95% confidence interval, 1.01\u20134.32; 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.<\/jats:p>","DOI":"10.3390\/jcm11092672","type":"journal-article","created":{"date-parts":[[2022,5,10]],"date-time":"2022-05-10T00:30:28Z","timestamp":1652142628000},"page":"2672","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":8,"title":["Efficacy and Safety of Naldemedine for Patients with Cancer with Opioid-Induced Constipation in Clinical Practice: A Real-World Retrospective Study"],"prefix":"10.3390","volume":"11","author":[{"given":"Hiromi","family":"Nishiba","sequence":"first","affiliation":[{"name":"Division of Pharmacy, Japan Community Health Care Organization (JCHO) Gunma Chuo Hospital, 1-7-13, Kouun, Maebashi 371-0025, Gunma, Japan"},{"name":"Graduate School of Pharmaceutical Sciences, Takasaki University of Health and Welfare, 37-1, Nakaorui, Takasaki 370-0033, Gunma, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3097-4255","authenticated-orcid":false,"given":"Hisao","family":"Imai","sequence":"additional","affiliation":[{"name":"Department of Respiratory Medicine, Comprehensive Cancer Center, International Medical Center, Saitama Medical University, 1397-1, Yamane, Hidaka 350-1298, Saitama, Japan"},{"name":"Division of Respiratory Medicine, Gunma Prefectural Cancer Center, 617-1, Takahayashi-nishi, Ota 373-8550, Gunma, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2444-5974","authenticated-orcid":false,"given":"Yukiyoshi","family":"Fujita","sequence":"additional","affiliation":[{"name":"Division of Pharmacy, Gunma Prefectural Cancer Center, 617-1, Takahayashi-nishi, Ota 373-8550, Gunma, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Eriko","family":"Hiruta","sequence":"additional","affiliation":[{"name":"Division of Pharmacy, Gunma Prefectural Cancer Center, 617-1, Takahayashi-nishi, Ota 373-8550, Gunma, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Takashi","family":"Masuno","sequence":"additional","affiliation":[{"name":"Division of Pharmacy, Fujioka General Hospital, 813-1, Nakagurisu, Fujioka 375-8503, Gunma, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shigeki","family":"Yamazaki","sequence":"additional","affiliation":[{"name":"Division of Pharmacy, Kiryu Kosei General Hospital, 6-3, Orihime, Kiryu 376-0024, Gunma, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hajime","family":"Tanaka","sequence":"additional","affiliation":[{"name":"Division of Pharmacy, Haramachi Red Cross Hospital, 698, Haramachi, Higashiagatsuma-machi, Agatsuma-gun 377-0882, Gunma, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Teruhiko","family":"Kamiya","sequence":"additional","affiliation":[{"name":"Department of Pharmacy, Tatebayashi Kosei General Hospital, 262-1, Narushima, Tatebayashi 374-8533, Gunma, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Masako","family":"Ito","sequence":"additional","affiliation":[{"name":"Division of Pharmacy, Ota Memorial Hospital, 455-1, Oshima, Ota 373-8585, Gunma, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Satoshi","family":"Takei","sequence":"additional","affiliation":[{"name":"Division of Pharmacy, Tone Central Hospital, 910-1, Numasu, Numata 378-0012, Gunma, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Masato","family":"Matsuura","sequence":"additional","affiliation":[{"name":"Division of Pharmacy, Gunma Saiseikai Maebashi Hospital, 564-1, Kamishinden, Maebashi 371-0821, Gunma, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Junnosuke","family":"Mogi","sequence":"additional","affiliation":[{"name":"Division of Pharmacy, Hidaka Hospital, 886, Nakao, Takasaki 370-0001, Gunma, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Koichi","family":"Minato","sequence":"additional","affiliation":[{"name":"Division of Respiratory Medicine, Gunma Prefectural Cancer Center, 617-1, Takahayashi-nishi, Ota 373-8550, Gunma, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kyoko","family":"Obayashi","sequence":"additional","affiliation":[{"name":"Graduate School of Pharmaceutical Sciences, Takasaki University of Health and Welfare, 37-1, Nakaorui, Takasaki 370-0033, Gunma, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"1968","published-online":{"date-parts":[[2022,5,9]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"428","DOI":"10.1016\/0885-3924(91)90041-2","article-title":"The Incidence of Narcotic-Induced Emesis","volume":"6","author":"Campora","year":"1991","journal-title":"J. Pain Symptom Manag."},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"231","DOI":"10.1007\/s00520-001-0332-1","article-title":"Double-Blind, Randomised, Parallel Group, Multinational, Multicentre Study Comparing a Single Dose of Ondansetron 24 mg p.o. with Placebo and Metoclopramide 10 mg t.d.s. p.o. in the Treatment of Opioid-Induced Nausea and Emesis in Cancer Patients","volume":"10","author":"Hardy","year":"2002","journal-title":"Support. Care Cancer"},{"key":"ref_3","doi-asserted-by":"crossref","first-page":"1393","DOI":"10.1053\/j.gastro.2016.02.031","article-title":"Bowel Disorders","volume":"150","author":"Mearin","year":"2016","journal-title":"Gastroenterology"},{"key":"ref_4","doi-asserted-by":"crossref","first-page":"2409","DOI":"10.2147\/DDDT.S141007","article-title":"A Comparison of Oral Controlled-Release Morphine and Oxycodone with Transdermal Formulations of Buprenorphine and Fentanyl in the Treatment of Severe Pain in Cancer Patients","volume":"11","author":"Nosek","year":"2017","journal-title":"Drug Des. Devel. Ther."},{"key":"ref_5","doi-asserted-by":"crossref","first-page":"246","DOI":"10.1016\/j.lfs.2018.07.028","article-title":"Pharmacological Profile of TAN-452, a Novel Peripherally Acting Opioid Receptor Antagonist for the Treatment of Opioid-Induced Bowel Syndromes","volume":"215","author":"Suzuki","year":"2018","journal-title":"Life Sci."},{"key":"ref_6","doi-asserted-by":"crossref","first-page":"4883","DOI":"10.1002\/cam4.2341","article-title":"Incidence of Opioid-Induced Constipation in Japanese Patients with Cancer Pain: A Prospective Observational Cohort Study","volume":"8","author":"Tokoro","year":"2019","journal-title":"Cancer Med."},{"key":"ref_7","doi-asserted-by":"crossref","first-page":"438","DOI":"10.1124\/jpet.119.264515","article-title":"Pharmacological Profile of Naldemedine, a Peripherally Acting \u00b5-Opioid Receptor Antagonist: Comparison with Naloxone and Naloxegol","volume":"373","author":"Kanemasa","year":"2020","journal-title":"J. Pharmacol. Exp. Ther."},{"key":"ref_8","first-page":"97","article-title":"Naldemedine for the Use of Management of Opioid Induced Constipation","volume":"50","author":"Urits","year":"2020","journal-title":"Psychopharmacol. Bull."},{"key":"ref_9","doi-asserted-by":"crossref","first-page":"1241","DOI":"10.1007\/s40265-019-01160-7","article-title":"Naldemedine: A Review in Opioid-Induced Constipation","volume":"79","author":"Blair","year":"2019","journal-title":"Drugs"},{"key":"ref_10","doi-asserted-by":"crossref","first-page":"3859","DOI":"10.1200\/JCO.2017.73.0853","article-title":"Randomized Phase III and Extension Studies of Naldemedine in Patients with Opioid-Induced Constipation and Cancer","volume":"35","author":"Katakami","year":"2017","journal-title":"J. Clin. Oncol."},{"key":"ref_11","doi-asserted-by":"crossref","first-page":"1461","DOI":"10.1093\/annonc\/mdy118","article-title":"Randomized phase III and Extension Studies: Efficacy and Impacts on Quality of Life of Naldemedine in Subjects with Opioid-Induced Constipation and Cancer","volume":"29","author":"Katakami","year":"2018","journal-title":"Ann. Oncol."},{"key":"ref_12","doi-asserted-by":"crossref","first-page":"3943","DOI":"10.1007\/s00520-022-06807-y","article-title":"Post-Marketing Surveillance of the Safety and Effectiveness of Naldemedine in the Management of Opioid-Induced Constipation in Patients with Cancer Pain in Japan","volume":"30","author":"Takata","year":"2022","journal-title":"Support. Care Cancer"},{"doi-asserted-by":"crossref","unstructured":"Hiruta, E., Fujita, Y., Imai, H., Masuno, T., Yamazaki, S., Tanaka, H., Kamiya, T., Ito, M., Takei, S., and Matsuura, M. (2021). 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. Medicina, 57.","key":"ref_13","DOI":"10.3390\/medicina57111233"},{"key":"ref_14","doi-asserted-by":"crossref","first-page":"225","DOI":"10.1007\/s11095-018-2501-7","article-title":"Population Pharmacokinetics and Exposure\u2013Response Relationships of Naldemedine","volume":"35","author":"Kubota","year":"2018","journal-title":"Pharm. Res."},{"key":"ref_15","doi-asserted-by":"crossref","first-page":"e000527","DOI":"10.1136\/esmoopen-2019-000527","article-title":"Safety and Efficacy of Naldemedine in Cancer Patients with Opioid-Induced Constipation: A Pooled, Subgroup Analysis of Two Randomised Controlled Studies","volume":"4","author":"Osaka","year":"2019","journal-title":"ESMO Open"},{"key":"ref_16","first-page":"1","article-title":"Ideal Body Weight Estimated from the Body Mass Index with the Lowest Morbidity","volume":"15","author":"Tokunaga","year":"1991","journal-title":"Int. J. Obes."},{"key":"ref_17","doi-asserted-by":"crossref","first-page":"7577","DOI":"10.1007\/s00520-021-06299-2","article-title":"Effectiveness of Naloxegol in Patients with Cancer Pain Suffering from Opioid-Induced Constipation","volume":"29","author":"Lemaire","year":"2021","journal-title":"Support. Care Cancer"},{"key":"ref_18","doi-asserted-by":"crossref","first-page":"271","DOI":"10.1007\/s40266-020-00753-2","article-title":"Safety and Efficacy of Naldemedine for the Treatment of Opioid-Induced Constipation in Patients with Chronic Non-Cancer Pain Receiving Opioid Therapy: A Subgroup Analysis of Patients \u2265 65 Years of Age >\/= 65 Years of Age","volume":"37","author":"Wild","year":"2020","journal-title":"Drugs Aging"},{"key":"ref_19","doi-asserted-by":"crossref","first-page":"1921","DOI":"10.1200\/JCO.2016.70.8453","article-title":"Phase IIb, Randomized, Double-Blind, Placebo-Controlled Study of Naldemedine for the Treatment of Opioid-Induced Constipation in Patients with Cancer","volume":"35","author":"Katakami","year":"2017","journal-title":"J. Clin. Oncol."},{"key":"ref_20","first-page":"1837","article-title":"Opioid-Induced Constipation and Bowel Dysfunction: A Clinical Guideline","volume":"18","author":"Bassotti","year":"2017","journal-title":"Pain Med."},{"key":"ref_21","doi-asserted-by":"crossref","first-page":"371","DOI":"10.3111\/13696990903430481","article-title":"Validation of the Bowel Function Index to Detect Clinically Meaningful Changes in Opioid-Induced Constipation","volume":"12","author":"Rentz","year":"2009","journal-title":"J. Med. Econ."}],"container-title":["Journal of Clinical Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/2077-0383\/11\/9\/2672\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,10]],"date-time":"2025-10-10T23:08:26Z","timestamp":1760137706000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/2077-0383\/11\/9\/2672"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,5,9]]},"references-count":21,"journal-issue":{"issue":"9","published-online":{"date-parts":[[2022,5]]}},"alternative-id":["jcm11092672"],"URL":"https:\/\/doi.org\/10.3390\/jcm11092672","relation":{},"ISSN":["2077-0383"],"issn-type":[{"type":"electronic","value":"2077-0383"}],"subject":[],"published":{"date-parts":[[2022,5,9]]}}}