Efficacy and Safety of Naldemedine for Opioid-Induced Constipation in Older Patients with Cancer: A Retrospective Study

Abstract

Abstract Background Opioids are pain relievers that are often associated with opioid-induced constipation (OIC) that worsens with age. We performed a multicenter, retrospective analysis on the efficacy and safety of naldemedine, an opioid receptor antagonist, in treating OIC in patients with cancer (age > 75 years). Methods The electronic medical records of cancer patients who received naldemedine at 10 Japanese institutions between June 7, 2017, and August 31, 2019, were retrieved. Patients aged ≥ 75 years who were treated with naldemedine for the first time and hospitalized for at least 7 days before and after initiating naldemedine therapy were included in this analysis. Results The patient’s bowel movements were evaluated for at least 7 days before and after naldemedine initiation. The response rate was 68.3%, and the frequency of bowel movements increased significantly after naldemedine administration in the overall population (p < 0.0001) and among those who defecated < 3 times/week before naldemedine administration (p < 0.0001). Diarrhea was the most frequent adverse event in all grades, observed in 45% of patients, of which 92.6% were Grade 1 or 2. Grade 4 or higher adverse events, including death, were not observed. Conclusions Naldemedine exhibits significant efficacy and safety in OIC treatment in older patients with cancer.