J Neurogastroenterol Motil.  2019 Oct;25(4):602-610. 10.5056/jnm18079.

Effects of Naloxegol on Gastrointestinal Transit and Colonic Fecal Volume in Healthy Participants Receiving Oxycodone

Affiliations
  • 1Mech-Sense, Department of Gastroenterology and Hepatology, Aalborg University Hospital, Aalborg, Denmark. aneso@rn.dk
  • 2Department of Clinical Medicine, Aalborg University, Aalborg, Denmark.
  • 3Department of Clinical Pharmacology, Aalborg University Hospital, Aalborg, Denmark.
  • 4Neurogastroenterology Unit, Department of Hepatology and Gastroenterology, Aarhus University Hospital, Aarhus, Denmark.
  • 5Mech-Sense, Department of Radiology, Aalborg University Hospital, Aalborg, Denmark.

Abstract

BACKGROUND/AIMS
Opioids cause gastrointestinal (GI) dysmotility, decrease gut secretion, and affect gut sphincters. Symptoms of opioid-induced bowel dysfunction may be alleviated by peripherally acting opioid antagonists like naloxegol, but detailed knowledge on GI effects of this drug is lacking. We hypothesized that naloxegol, compared to placebo, would reduce GI transit time and colonic fecal volume in opioid-treated healthy participants.
METHODS
We conducted a randomized, double-blinded, single-center, 2-way cross-over study in 24 healthy males, randomized to a 6 day treatment period of oxycodone (15 mg twice a day) co-administered with either naloxegol (25 mg once a day) or matching placebo. Participants swallowed an electromagnetic capsule which determined GI transit times. Colonic fecal volume was quantified with magnetic resonance imaging both pre-treatment and post-treatment.
RESULTS
Naloxegol reduced total GI transit time by 21% (56 hours vs 71 hours, P = 0.02) and colonic transit time by 23% (45 hours vs 59 hours, P < 0.01), compared to placebo. However, no difference in colonic fecal volume was found (818 mL vs 884 mL, P = 0.20).
CONCLUSIONS
Short-term administration of naloxegol in healthy participants reverses the retardation of total GI and colonic transit induced by oxycodone. This supports the use of naloxegol in the treatment of GI side effects to opioid treatment, and add knowledge to the current understanding of mechanisms behind peripherally-acting opioid antagonists.

Keyword

Analgesics, opioid; Constipation; Motility; Naloxegol; Oxycodone

MeSH Terms

Analgesics, Opioid
Colon*
Constipation
Cross-Over Studies
Gastrointestinal Transit*
Healthy Volunteers*
Humans
Magnetic Resonance Imaging
Magnets
Male
Narcotic Antagonists
Oxycodone*
Analgesics, Opioid
Narcotic Antagonists
Oxycodone
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