[Efficacy of Naldemedine in opioid-induced constipation in cancer patients]

This study evaluated the efficacy and safety of Naldemedine, an oral peripheral μ-opioid receptor antagonists (PAMORAs), in cancer patients with opioid-induced constipation (OIC). A single-center, single-arm, prospective real-world trial was conducted, enrolling 12 patients aged 18 years and above who had been on stable opioid analgesic therapy for at least 7 days and met the criteria for OIC. Participants were administered 0.2 mg/d Naldemedine orally for a minimum of 12 weeks (up to 48 weeks). The primary endpoint was the proportion of spontaneous bowel movement (SBM) responders within the first two weeks of treatment. Secondary endpoints included complete SBM (CSBM) responder rates and other efficacy endpoints, as well as safety assessments and quality of life. The results demonstrated SBM and CSBM responder rates of 66.7%(8/12) and 33.3%(4/12), respectively, within the initial two weeks. The mean frequency of SBM/CSBM increased for (3.8±2.7)/(1.3±1.9) times when compared with baseline after 2-week of treatment. Notably, 66.7%(8/12) and 33.3%(4/12) of patients experienced≥1 SBM or CSBM within 24 hours after the first dose, with median times to first SBM and CSBM being 4.0 and 16.6 hours post-administration. Mild treatment-related adverse events were reported in 16.7%(2/12) of patients. Naldemedine improved QoL. Naldemedine shows promising efficacy and manageable safety in cancer pain patients with OIC.