Naloxegol Has No Effect on Opioid Dose in Opioid-Tied Constipation
WEDNESDAY, Sept. 20, 2017 -- For patients with noncancer pain and opioid-induced constipation (OIC), naloxegol has no clinically relevant effect on patient-reported pain levels or mean daily opioid dose, according to research published online Sept. 12 in PAIN Practice.
Lynn Webster, M.D., from PRA Health Sciences in Salt Lake City, and colleagues summarized results from pain and opioid use assessments with naloxegol in adults with OIC and chronic noncancer pain. The efficacy and safety of oral naloxegol were assessed in two phase 3 randomized, double-blind studies (KODIAC-04 and KODIAC-05).
The researchers found that the mean daily numerical rating scale average pain scores varied from 4.5 to 4.8 for all groups in the 652 participants in KODIAC-04, and were 4.6 for each group of the 700 participants in KODIAC-05. The respective mean changes from baseline in average pain did not differ significantly for placebo, naloxegol 12.5 mg, and naloxegol 25 mg. Mean daily opioid doses ranged from 135.6 to 143.2 morphine equivalent units (MEUs)/day and from 119.9 to 151.7 MEUs/day in KODIAC-04 and KODIAC-05, respectively. The mean changes from baseline dose did not differ significantly for placebo or naloxegol. Few changes were seen in maintenance opioid dose; similar reasons for such changes were seen across treatment groups.
"Centrally-mediated opioid analgesia was maintained during treatment with naloxegol in patients with noncancer pain and OIC," the authors write.
Several authors disclosed financial ties to pharmaceutical companies, including AstraZeneca, which manufactures naloxegol and funded the study.
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Posted: September 2017