{Reference Type}: Journal Article
{Title}: 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.
{Author}: Shimizu M;Maeda I;Kessoku T;Ishiki H;Matsuura T;Hiratsuka Y;Matsuda Y;Hasegawa T;Imai K;Oyamada S;Satomi E; ;
{Journal}: Support Care Cancer
{Volume}: 32
{Issue}: 8
{Year}: 2024 Jul 10
{Factor}: 3.359
{DOI}: 10.1007/s00520-024-08716-8
{Abstract}: <B>OBJECTIVE: </B>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.<BR><B>METHODS: </B>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.<BR><B>RESULTS: </B>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.<BR><B>CONCLUSIONS: </B>Conclusively, naldemedine is effective and safe for OIC treatments in real-world palliative care settings.<BR><B>BACKGROUND: </B>UMIN000031381, registered 20/02/2018.