DOI: 10.1097/meg.0000000000002746 ISSN: 0954-691X

Efficacy and safety of naldemedine for opioid-induced constipation in older patients with cancer: a retrospective study

Hisao Imai, Yukiyoshi Fujita, Eriko Hiruta, Takashi Masuno, Shigeki Yamazaki, Hajime Tanaka, Teruhiko Kamiya, Mitsuru Sandoh, Satoshi Takei, Kazuya Arai, Hiromi Nishiba, Junnosuke Mogi, Shiro Koizuka, Taeko Saito, Kyoko Obayashi, Kyoichi Kaira, Koichi Minato
  • Gastroenterology
  • Hepatology


Opioids are pain relievers that are often associated with opioid-induced constipation (OIC) that worsens with age. We performed a multicenter, retrospective analysis on the efficacy and safety of naldemedine, an opioid receptor antagonist, in treating OIC in patients with cancer (age >75 years).


The electronic medical records of cancer patients who received naldemedine at 10 Japanese institutions between 7 June 2017 and August 31, 2019, were retrieved. Patients aged ≥75 years who were treated with naldemedine for the first time and hospitalized for at least 7 days before and after initiating naldemedine therapy were included in this analysis.


Sixty patients were observed for at least 7 days before and after starting naldemedine. The response rate was 68.3%, and the frequency of bowel movements increased significantly after naldemedine administration in the overall population (P < 0.0001) and among those who defecated <3 times/week before naldemedine administration (P < 0.0001). Diarrhea was the most frequent adverse event in all grades, observed in 45% of patients, of which 92.6% were Grade 1 or 2. Grade 4 or higher adverse events, including death, were not observed.


Naldemedine exhibits significant efficacy and safety in OIC treatment in older patients with cancer.

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