A renal impairment subgroup analysis of the safety and efficacy of naldemedine for the treatment of opioid-induced constipation in patients with chronic non-cancer pain receiving opioid therapy
Journal of Pain Research Mar 27, 2020
Webster LR, et al. - Given the renal excretion of naldemedine, which have been approved for the treatment of opioid-induced constipation (OIC), researchers here investigated the safety and efficacy of naldemedine in patients with renal impairment (RI) via performing a subgroup analysis integrating data from 3 phase 3 trials (COMPOSE-1, COMPOSE-2, COMPOSE-3). Oral naldemedine 0.2 mg or placebo was administered once daily to patients (age 18–80 years) with chronic non-cancer pain (CNCP) and OIC. They analyzed, in total, 2,328 patients. The naldemedine and placebo groups exhibited similar incidence of treatment-emergent adverse events (TEAEs; overall, 47.1% vs 45.6%; normal, 44.6% vs 43.6%; mild RI, 49.0% vs 44.7%; moderate RI, 46.6% vs 55.9%). Patients in the naldemedine group more frequently experienced GI-related TEAEs than those receiving placebo (overall, 21.8% vs 13.8%; normal, 21.6% vs 12.5%; mild RI, 22.6% vs 14.7%; moderate RI, 18.0% vs 14.2%). Response was reported in a significantly greater proportion of patients in the naldemedine 0.2 mg group vs the placebo group (overall, 50.1% vs 34.1%; normal, 52.0% vs 39.3%; mild RI, 48.3% vs 30.3%; moderate RI, 52.5% vs 31.7%). Findings establishes that patients generally well tolerate OIC treatment with naldemedine 0.2 mg and effectiveness of this treatment for managing CNCP in those with mild or moderate RI. The study population had safety and efficacy results consistent with the overall population.
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