Naldemedine is effective for OIC in older patients

  • Wild J & al.
  • Drugs Aging
  • 21 Feb 2020

  • curated by Kelli Whitlock Burton
  • Clinical Essentials
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Takeaway

  • Naldemedine is as safe and effective for opioid-induced constipation (OIC) in older patients with chronic noncancer pain as it is for younger patients, with tolerable adverse events.

Why this matters

  • Although clinical trials have shown that naldemedine is effective for OIC, they did not compare effectiveness between younger and older patients.
  • Older patients have increased risk for OIC.

Study design

  • COMPOSE-1, COMPOSE-2, and COMPOSE-3 trials included 2328 patients (aged 18-80 years) with chronic noncancer pain ≥3 months.
  • Funding: Shionogi Inc.; others.

Key results

  • 344 patients were aged ≥65 years.
  • These patients receiving naldemedine vs the overall naldemedine group had:
    • Similar treatment-emergent adverse event (TEAE) rates: 45.9% vs 47.1%.
    • Similar AE rates: 18.6% vs 20.1%.
    • Lower rate of gastrointestinal TEAEs: 20.2% vs 21.8%.
    • Similar rates of opioid withdrawal-related TEAEs: 1.1% vs 1.0%.
    • Lower rate of TEAEs involving possible opioid withdrawal: 1.1% vs 1.7%.
  • Naldemedine-treated patients vs placebo had higher proportion of responders for:
    • Overall population: 50.1% vs 34.1% (P<.0001>
    • Those aged ≥65 years: 51.8% vs 37.6%.

Limitations

  • Post hoc analysis.

Coauthored with Vijay Rathod, PhD