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.

PURPOSE: 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. CONCLUSION: Conclusively, naldemedine is effective and safe for OIC treatments in real-world palliative care settings. TRIAL REGISTRATION NUMBER: UMIN000031381, registered 20/02/2018.

Prevalence of osteochondritis dissecans of the capitellum in elementary school baseball players based on ultrasonographic screening: a 15-year overview in Tokushima, Japan.

Background: Although several operative procedures have evolved for capitellar osteochondritis dissecans (OCD), the best outcome is achieved by early detection and conservative treatment. The objective of this study was to clarify changes in the prevalence of capitellar OCD in young baseball players over a long-term period based on consistent criteria in Tokushima, Japan between 2006 and 2020. Methods: The number of players who underwent screening and the discovery rate of capitellar OCD during the study period were investigated. School grade and radiographic stage were also evaluated. Results: The confirmation rate was significantly higher when ultrasonographic screening was performed than when screening was based on physical findings (65.8% vs. 1.9%, P < .001). The overall incidence of OCD in elementary school players based on ultrasonographic screening was 1.4% during the 10-year study period. Twenty-one (10.8%) of the 195 players identified to have OCD had experienced lateral elbow pain. When classified radiographically, the lesion was stage I in 73.3% of cases, stage II in 24.1%, and stage III in 2.6%. No cases of OCD were diagnosed before the fourth grade. The prevalence rates increased gradually from the fourth grade to the sixth grade. Conclusion: Ultrasonographic screening could be more effective for detecting capitellar OCD than screening based on physical findings. The overall prevalence of OCD among elementary school players was 1.4% over 10 years. The prevalence rates increased gradually from the fourth grade onwards.