Open AccessA retrospective study of the efficacy and safety of naldemedine for opioid‐induced constipation in thoracic cancer patients
Author(s) -
Imai Hisao,
Fujita Yukiyoshi,
Hiruta Eriko,
Masuno Takashi,
Yamazaki Shigeki,
Tanaka Hajime,
Kamiya Teruhiko,
Sandoh Mitsuru,
Takei Satoshi,
Arai Kazuya,
Nishiba Hiromi,
Mogi Junnosuke,
Kaira Kyoichi,
Minato Koichi
Publication year - 2022
Publication title -
thoracic cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.823
H-Index - 28
eISSN - 1759-7714
pISSN - 1759-7706
DOI - 10.1111/1759-7714.14557
Subject(s) - medicine , constipation , adverse effect , defecation , retrospective cohort study , diarrhea , gastroenterology , surgery
Background We conducted a multicenter, retrospective study on the efficacy and safety of naldemedine in thoracic cancer patients using opioids in clinical practice. Methods We retrospectively evaluated thoracic cancer patients treated with naldemedine at 10 institutions in Japan. Clinical data of patients administered naldemedine between June 2017 and August 2019 were extracted from electronic medical records. Inclusion criteria were as follows: (i) patients hospitalized for at least seven days before and after naldemedine administration, and (ii) those whose frequency of defecation was entered in the medical records. Results Forty patients were analyzed, and defecation frequency was observed for at least seven days before and after naldemedine administration. The response rate was 65.0% (95% CI: 50.2%–79.7%). The number of defecations increased significantly after naldemedine administration in the overall population, as well as among only those who defecated <3 times/week before naldemedine administration, and those that were administered ≥30 mg/day of morphine equivalent. Diarrhea was the most common adverse event in all grades, occurring in 11 patients (27.5%), of which 9 (81.8%) were grade 1 or 2. None of the patients experienced grade 4 or higher adverse events. Conclusion The efficacy and safety of naldemedine for thoracic cancer patients in clinical practice were comparable with those of prospective studies, which suggest that naldemedine may be effective and feasible for most thoracic cancer patients.