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Naloxegol improved opioid-induced constipation in patients with noncancer pain
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Naloxegol, an orally administered peripheral micro-opioid antagonist, improved opioid-induced constipation in patients with noncancer pain in recent trials.
William D. Chey, MD, University of Michigan division of gastroenterology, and colleagues conducted two identical double blind, parallel-group, phase 3 studies funded by AstraZeneca at 115 (study A) and 142 (study B) centers in the United States and Europe, respectively, spanning March 2011 to August 2012 and March 2011 to September 2012.
Eligible patients with confirmed opioid-induced constipation were stratified based on laxative-response and randomly assigned to placebo (A, n=214; B, n=232), or treatment groups receiving 12.5 mg (A, n=213; B, n=232) or 25 mg (A, n=214; B, n=232) naloxegol once daily for 12 weeks. Naloxegol is among an emerging class of drugs that treat GI side effects of opioids while preserving opioid-mediated analgesia.
William D. Chey
Patients were primarily evaluated for response rate, defined as at least three spontaneous bowel movements weekly and an increase of at least one spontaneous bowel movement for no less than 9 treatment weeks, including at least 3 of the final 4 weeks.
Both naloxegol dose groups showed greater response than placebo groups in study A (12.5 mg, P=.02; 25 mg, P=.001), as did the 25-mg group (P=.02) in study B. In subsets of patients with inadequate laxative response, higher rates of response vs. placebo were seen in the 25-mg groups (A, P=.002; B, P=.01) and in the 12.5-mg group in study A (P=.03).
Time to first spontaneous bowel movement was shorter in both dose groups compared with placebo in study A, and in study B’s 25-mg group (all P<.001). Increases also were seen in mean days per week with one or more spontaneous bowel movements with both dose groups in study A and with the 25-mg group in study B (all P<.001). The most common adverse events, occurring more often in the 25-mg naloxegol groups, were mild to moderate abdominal pain, diarrhea, nausea and vomiting.
These results “confirm the efficacy of … naloxegol for the treatment of opioid-induced constipation in patients with noncancer pain,” the researchers concluded. “In addition, other constipation-related endpoints, including the time to the first spontaneous bowel movement, mean number of days per week with one or more spontaneous bowel movements, number of weekly spontaneous bowel movements, severity of straining, and stool consistency, were improved.”
Disclosure: See the study for a full list of relevant financial disclosures.
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