Naldemedine yields good results for OIC regardless of kidney function

  • J Pain Res

  • de Kelli Whitlock Burton
  • Clinical Essentials
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Takeaway

  • Patients with chronic noncancer pain and renal impairment who received naldemedine for opioid-induced constipation (OIC) reported similar decreases in abdominal pain, diarrhea, nausea, and vomiting as patients with normal renal function, with similar adverse events (AEs).

Why this matters

  • Naldemedine is renally excreted, and its efficacy and safety in patients with OIC and renal impairment were unknown.

Study design

  • Subgroup analysis of 2328 patients (age range, 18-80 years) with chronic noncancer pain (CNCP) and OIC collected from COMPOSE-1, COMPOSE-2, and COMPOSE-3.
  • Patients received either oral naldemedine 0.2 mg or placebo once daily.
  • Funding: Shionogi Inc., Florham Park, NJ.

Key results

  • Naldemedine group vs placebo had a significantly higher proportion of responders: 50.1% vs 34.1% (P<.0001>
  • In patients with renal impairment (RI), naldemedine vs placebo yielded similar decreases in incidence of:
    • Abdominal pain:
      • Normal RI: 8.3% vs 3.7%.
      • Mild RI: 10.4% vs 3.0%.
      • Moderate RI: 7.5% vs 3.9%.
    • Diarrhea:
      • Normal RI: 9.2% vs 1.9%. 
      • Mild RI: 6.9% vs 2.6%.
      • Moderate RI: 6.0% vs 3.1%.
    • Nausea:
      • Normal RI: 4.8% vs 3.7%. 
      • Mild RI: 5.7% vs 2.4%. 
      • Moderate RI: 5.3% vs 6.3%.
    • Vomiting:
      • Normal RI: 3.0% vs 1.7%. 
      • Mild RI: 2.0% vs 0.7%.
      • Moderate RI: 0.8% vs 2.4%.

Limitations

  • Post hoc analysis.

Coauthored with Vijay Rathod PhD