- 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.
- 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.
- 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%.
- Post hoc analysis.
Coauthored with Vijay Rathod, PhD