Abstract：
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.
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.
摘要：
目的：在本研究中，我们旨在评估纳地米定治疗晚期癌症患者阿片类药物引起的便秘（OIC）的安全性和有效性，正在接受姑息治疗的人，并特别探讨了其早期影响。
方法：日本14个机构的姑息治疗团队和住院姑息治疗单位被纳入这个多中心，prospective,观察性研究。纳入新处方每日口服剂量为0.2mg纳迪米定的患者。首次服用纳地米定后24小时内的自发排便（SBM）被认为是主要结局。然而,次要结局包括每周SBM频率变化和不良事件.
结果：共纳入204名患者，184名患者完成了为期7天的研究。参与者的平均年龄(103名男性，101名女性）为63±14岁。在肺部检测到原发癌（23.5%），胃肠道（13.7%），和泌尿器官(9.3%)。相当比例的患者（34.8％）的ECOG表现状态为3-4。大多数患者正在接受积极的癌症治疗，然而,40.7%的患者接受了最好的支持治疗。在第一次纳地米定剂量的24小时内，146例患者（71.6%，95％CI：65.4-77.8％）经历了SBM。每周SBM计数在62.7％的参与者中增加。主要不良反应包括腹泻和腹痛,在17.6%和5.4%的患者中检测到，分别。然而,未观察到严重不良事件.
结论：最后，naldemedine是有效和安全的OIC治疗在现实世界的姑息治疗设置。
背景：UMIN000031381，注册于2018年2月20日。
方法：日本14个机构的姑息治疗团队和住院姑息治疗单位被纳入这个多中心，prospective,观察性研究。纳入新处方每日口服剂量为0.2mg纳迪米定的患者。首次服用纳地米定后24小时内的自发排便（SBM）被认为是主要结局。然而,次要结局包括每周SBM频率变化和不良事件.
结果：共纳入204名患者，184名患者完成了为期7天的研究。参与者的平均年龄(103名男性，101名女性）为63±14岁。在肺部检测到原发癌（23.5%），胃肠道（13.7%），和泌尿器官(9.3%)。相当比例的患者（34.8％）的ECOG表现状态为3-4。大多数患者正在接受积极的癌症治疗，然而,40.7%的患者接受了最好的支持治疗。在第一次纳地米定剂量的24小时内，146例患者（71.6%，95％CI：65.4-77.8％）经历了SBM。每周SBM计数在62.7％的参与者中增加。主要不良反应包括腹泻和腹痛,在17.6%和5.4%的患者中检测到，分别。然而,未观察到严重不良事件.
结论：最后，naldemedine是有效和安全的OIC治疗在现实世界的姑息治疗设置。
背景：UMIN000031381，注册于2018年2月20日。
