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

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 naldemedi...

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Veröffentlicht in:	Journal of pain research 2020-01, Vol.13, p.605-612
Hauptverfasser:	Webster, Lynn R, Hale, Martin E, Yamada, Tadaaki, Wild, James E
Format:	Artikel
Sprache:	eng
Schlagworte:	Abdomen Analgesics Analysis Cancer Cancer pain Cancer patients Cancer therapies Cancer treatment Chronic illnesses Comorbidity Complications and side effects Constipation constipation/chemically induced Diarrhea Drug dosages Drug therapy Drug withdrawal Kidney diseases Kidney failure Laxatives Naldemedine Narcotics opioid analgesics opioid-related disorders Opioids Original Research Pain renal insufficiency Studies
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Zusammenfassung:	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 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 m ), mild (≥60 to
ISSN:	1178-7090 1178-7090
DOI:	10.2147/JPR.S237833