SLR - December 2014 - Tyson Tabora
Reference: Chey WD, Webster L, Sostek M, Lappalainen J, Barker PN, Tack J. Naloxegol for Opioid-induced Constipation in Patients with Noncancer Pain. N Engl J Med. 2014 Jun 19; 370(25): 2387-96.Scientific Literature Review
Reviewed By: Tyson Tabora, DPM
Residency Program: Bethesda Health, Inc.
Podiatric Relevance: As foot and ankle surgeons, we often prescribe opioid medications for post-operative pain control. One of the most common side effects of these opioid pain medications is constipation, which can, and may lead to serious complications if not treated appropriately. In fact, it has been reported that 40-90 percent of patients taking opioids have constipation and other gastrointestinal side effects. As prescribers of opioid medications, we should be aware of alternative treatments for constipation when other options have been exhausted. The authors were attempting to compare the effectiveness of the Naloxegol to placebo in patients with an inadequate response to laxatives.
Methods: This article included two identical phase three, double-blind studies. Outpatients with opioid induced constipation were randomly assigned to receive a daily dose of 12.5 or 25mg of naloxegol or placebo. The end point was a 12 week response rate (>3 spontaneous bowel movements per week and an increase from baseline of >1 spontaneous bowel movements for >9 of 12 weeks and for >3 of the final four weeks). Key secondary end points in the subpopulation of patients were the response to laxatives before enrollment, time to first postdose spontaneous bowel movement, and mean number of days per week with one or more spontaneous bowel movements.
Results: Response rates were significantly higher with 25mg of naloxegol than with placebo.
Conclusions: Naloxegol treatment resulted in significantly higher rate of treatment response compared to placebo, without reducing opioid-mediated analgesia.