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Lynn R Webster,1 Martin E Hale,2 Tadaaki Yamada,3 James E Wild4 1PRA Health Sciences, Salt Lake City, UT, USA; 2Gold Coast Research LLC, Plantation, FL, USA; 3Shionogi, Inc., Florham Park, NJ, USA; 4Upstate Clinical Research Associates, Williamsville, NY, USACorrespondence: Lynn R WebsterPRA Health Sciences, Salt Lake City, UT, USATel +1 801 269-8200Email lrwebstermd@gmail.comPurpose: Naldemedine, an oral, peripherally acting μ-opioid receptor antagonist approved for the treatment of opioid-induced constipation (OIC), is renally excreted. This subgroup analysis integrated data from 3 Phase 3 trials (COMPOSE-1, COMPOSE-2, COMPOSE-3) to evaluate the safety and efficacy of naldemedine in patients with renal impairment (RI).Patients and Methods: Patients age 18– 80 years with chronic non-cancer pain (CNCP) and OIC received oral naldemedine 0.2 mg or placebo once daily. RI subgroups consisted of patients with normal function (baseline glomerular filtration rate ≥ 90 mL/min/1.73 m2), mild (≥ 60 to < 90 mL/min/1.73 m2), and moderate (≥ 30 to < 60 mL/min/1.73 m2) RI. Safety assessments based on ≤ 12 weeks of treatment from all 3 studies included incidence of treatment-emergent adverse events (TEAEs). Efficacy was based on the proportion of responders in COMPOSE-1 and COMPOSE-2 only, defined as ≥ 3 spontaneous bowel movements (SBMs)/week and a ≥ 1-SBM/week increase from baseline for ≥ 9 of 12 weeks and ≥ 3 of the last 4 weeks.Results: In total, 2328 patients were included in this analysis. The incidence of TEAEs was similar in the naldemedine and placebo groups (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%). GI-related TEAEs occurred more frequently in the naldemedine group versus 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%). A significantly greater proportion of pati