%0 Journal Article
%T The safety and effectiveness of naldemedine for opioid-induced constipation in patients with advanced cancer in real-world palliative care settings: a multicenter prospective observational study.
%A Shimizu M
%A Maeda I
%A Kessoku T
%A Ishiki H
%A Matsuura T
%A Hiratsuka Y
%A Matsuda Y
%A Hasegawa T
%A Imai K
%A Oyamada S
%A Satomi E
%A
%J Support Care Cancer
%V 32
%N 8
%D 2024 Jul 10
%M 38985364
%F 3.359
%R 10.1007/s00520-024-08716-8
%X OBJECTIVE: In this study, we aimed to evaluate the safety and effectiveness of naldemedine for treating opioid-induced constipation (OIC) in patients with advanced cancer, who are receiving palliative care, and particularly explored its early effects.
METHODS: Palliative care teams and inpatient palliative care units across 14 institutions in Japan were included in this multicenter, prospective, observational study. Patients who were newly prescribed a daily oral dose of 0.2 mg naldemedine were enrolled. The spontaneous bowel movement (SBM) within 24 h after the first dose of naldemedine was considered the primary outcome, whereas, the secondary outcomes included weekly changes in SBM frequency and adverse events.
RESULTS: A total of 204 patients were enrolled and 184 completed the 7-day study. The average age of the participants (103 males, 101 females) was 63 ± 14 years. The primary cancer was detected in the lungs (23.5%), gastrointestinal tract (13.7%), and urological organs (9.3%). A considerable proportion of patients (34.8%) had ECOG performance status of 3-4. Most patients were undergoing active cancer treatment, however, 40.7% of the patients were receiving the best supportive care. Within 24 h of the first naldemedine dose, 146 patients (71.6%, 95% CI: 65.4-77.8%) experienced SBMs. The weekly SBM counts increased in 62.7% of the participants. The major adverse events included diarrhea and abdominal pain, detected in 17.6% and 5.4% of the patients, respectively. However, no serious adverse events were observed.
CONCLUSIONS: Conclusively, naldemedine is effective and safe for OIC treatments in real-world palliative care settings.
BACKGROUND: UMIN000031381, registered 20/02/2018.