AEs With Movantik, Placebo Compared in Analyses of Elderly Patients
Movantik (naloxegol; AstraZeneca) was found to have a similar incidence of adverse events among elderly patients as compared to placebo or usual care, safety analyses presented at Digestive Disease Week 2015 have shown.
An analysis of the Phase 3 KODIAC-04, KODIAC-05, and KODIAC-08 studies evaluated the effects of Movantik 12.5mg or 25mg daily vs. placebo among patients ≥65 years old with opioid-induced constipation (OIC) and chronic non-cancer pain. Overall safety results in this subset were consistent with those seen in the overall patients populations from Phase 3 studies. The most common adverse reactions with Movantik as compared to placebo in clinical trials were abdominal pain, diarrhea, nausea, flatulence, vomiting, headache, and hyperhidrosis.
Some specific findings from the sub-analyses in patients aged ≥65 years old include:
- KODIAC-04 and KODIAC-05 (n=147/1,331): the incidence of adverse events was naloxegol 12.5mg, 50%; naloxegol 25mg, 56.6%; and placebo, 62.0%. The incidence of serious adverse events and discontinuations due to adverse events were comparable among treatment groups in the 12-week pool.
- KODIAC-08 (n=76/721): the incidence of adverse events was naloxegol 25mg, 86.7%; usual care, 83.9%. The incidence of serious adverse events were 16.1% for usual care vs .15.6% for naloxegol 25mg.
Movantik is an oral peripherally-acting mu-opioid receptor antagonist (PAMORA) medication for the treatment of opioid-induced constipation in adult patients with chronic, non-cancer pain.
For more information call (800) 237-8898 or visit Movantik.com.