A Retrospective Study of the Efficacy and Safety of Naldemedine for Treatment of Opioid-Induced Constipation in Patients with Hepatobiliary Pancreatic Cancer
Teruhiko Kamiya,
Hisao Imai,
Yukiyoshi Fujita,
Eriko Hiruta,
Takashi Masuno,
Shigeki Yamazaki,
Hajime Tanaka,
Mitsuru Sandoh,
Satoshi Takei,
Kazuya Arai,
Hiromi Nishiba,
Junnosuke Mogi,
Shiro Koizuka,
Taeko Saito,
Kyoko Obayashi,
Kyoichi Kaira,
Koichi Minato
Affiliations
Teruhiko Kamiya
Department of Pharmacy, Tatebayashi Kosei General Hospital, 262-1 Narushima, Tatebayashi 374-8533, Gunma, Japan
Hisao Imai
Division of Respiratory Medicine, Gunma Prefectural Cancer Center, 617-1 Takahayashi-nishi, Ota 373-0828, Gunma, Japan
Yukiyoshi Fujita
Division of Pharmacy, Gunma Prefectural Cancer Center, 617-1 Takahayashi-nishi, Ota 373-0828, Gunma, Japan
Eriko Hiruta
Division of Pharmacy, Gunma Prefectural Cancer Center, 617-1 Takahayashi-nishi, Ota 373-0828, Gunma, Japan
Takashi Masuno
Division of Pharmacy, Fujioka General Hospital, 813-1 Nakagurisu, Fujioka 375-8503, Gunma, Japan
Shigeki Yamazaki
Division of Pharmacy, Kiryu Kosei General Hospital, 6-3 Orihime, Kiryu 376-0024, Gunma, Japan
Hajime Tanaka
Division of Pharmacy, Haramachi Red Cross Hospital, 698 Haramachi, Higashiagatsuma-machi, Agatsuma-gun 377-0882, Gunma, Japan
Mitsuru Sandoh
Division of Pharmacy, Ota Memorial Hospital, 455-1 Oshima, Ota 373-8585, Gunma, Japan
Satoshi Takei
Division of Pharmacy, Tone Central Hospital, 910-1 Numasu, Numata 378-0012, Gunma, Japan
Kazuya Arai
Division of Pharmacy, Gunma Saiseikai Maebashi Hospital, 564-1 Kamishinden, Maebashi 371-0821, Gunma, Japan
Hiromi Nishiba
Division of Pharmacy, Japan Community Health Care Organization (JCHO) Gunma Chuo Hospital, 1-7-13 Kouun, Maebashi 371-0025, Gunma, Japan
Junnosuke Mogi
Division of Pharmacy, Hidaka Hospital, 886 Nakao-machi, Takasaki 370-0001, Gunma, Japan
Shiro Koizuka
Division of Palliative Care, Gunma Prefectural Cancer Center, 617-1 Takahayashi-nishi, Ota 373-0828, Gunma, Japan
Taeko Saito
Division of Pharmacy, Gunma Prefectural Cancer Center, 617-1 Takahayashi-nishi, Ota 373-0828, Gunma, Japan
Kyoko Obayashi
Laboratory of Clinical Pharmacy, Faculty of Pharmacy, Takasaki University of Health and Welfare, 37-1 Nakaorui, Takasaki 370-0033, Gunma, Japan
Kyoichi Kaira
Department of Respiratory Medicine, Comprehensive Cancer Center, International Medical Center, Saitama Medical University, 1397-1 Yamane, Hidaka 350-1298, Saitama, Japan
Koichi Minato
Division of Respiratory Medicine, Gunma Prefectural Cancer Center, 617-1 Takahayashi-nishi, Ota 373-0828, Gunma, Japan
Background and Objectives: Opioid analgesics, which are used for cancer-related pain management, cause opioid-induced constipation (OIC). Naldemedine, a peripheral opioid receptor antagonist, is an OIC-modifying agent, but no focused efficacy and safety analysis has been conducted for its use in hepatobiliary pancreatic cancers. We performed a multi-institutional study on the efficacy and safety of naldemedine in patients with hepatobiliary pancreatic cancer using opioids in clinical practice. Materials and Methods: We retrospectively evaluated patients with hepatobiliary pancreatic cancer (including liver, biliary tract, and pancreatic cancers) treated with opioids and naldemedine during hospitalization at ten institutions in Japan from June 2017 to August 2019. We assessed the frequency of bowel movements before and after the initiation of naldemedine therapy. Responders were defined as patients who defecated ≥3 times/week, with an increase from a baseline of ≥1 defecations/week over seven days after the initiation of naldemedine administration. Results: Thirty-four patients were observed for one week before and one week after starting naldemedine. The frequency of bowel movements increased by one over the baseline frequency or to at least thrice per week in 21 patients. The response rate was 61.7% (95% confidence interval: 45.4–78.0%). The median number of weekly bowel movements before and after naldemedine treatment was 2 (range: 0–9) and 6 (range: 1–17), respectively, in the overall population (n = 34); the increase in the number of bowel movements following naldemedine administration was statistically significant (Wilcoxon signed-rank test, p Conclusions: Naldemedine is effective, and its use may be safe in clinical practice for patients with hepatobiliary pancreatic cancer receiving opioid analgesics.