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Effects of Lubiprostone, an Intestinal Secretagogue, on Electrolyte Homeostasis in Chronic Idiopathic and Opioid-induced Constipation.

Authors
  • Rao, Satish S C1
  • Lichtlen, Peter2
  • Habibi, Sepideh3
  • 1 Augusta University Medical Center, Augusta, GA.
  • 2 Mallinckrodt Pharmaceuticals, Zug, Switzerland. , (Switzerland)
  • 3 Mallinckrodt Pharmaceuticals, Rockville, MD.
Type
Published Article
Journal
Journal of clinical gastroenterology
Publication Date
Jul 01, 2021
Volume
55
Issue
6
Pages
512–519
Identifiers
DOI: 10.1097/MCG.0000000000001385
PMID: 32569031
Source
Medline
Language
English
License
Unknown

Abstract

To assess short-term and long-term effects of lubiprostone, a type-2 chloride channel activator, on electrolyte homeostasis. Conventional laxatives are associated with electrolyte imbalances. Lubiprostone is a type-2 chloride channel activator approved for treating chronic idiopathic constipation (CIC), opioid-induced constipation (OIC), and constipation-predominant irritable bowel syndrome in women. It induces intestinal fluid secretion, possibly affecting water and electrolyte homeostasis. We investigated short-term and long-term effects of lubiprostone on electrolyte, blood urea nitrogen (BUN), and creatinine levels using pooled data from CIC and OIC patients. Data were pooled from 10 CIC and OIC studies-6 double-blind, randomized, placebo-controlled studies and 4 open-label, long-term studies. Total duration of lubiprostone exposure was from 3 weeks (short-term: CIC, 3 to 4 wk; OIC, placebo-controlled, 12 wk) to 48 weeks (long-term: CIC, 24 to 48 wk; OIC, 48 wk). Sodium, chloride, potassium, magnesium, BUN, and creatinine levels were examined at baseline and final assessment. Overall, 3209 patients were assessed. In the double-blind, placebo-controlled studies, there were no clinically meaningful differences in levels of electrolytes, BUN, and creatinine between lubiprostone and placebo groups, and in changes from baseline levels with long-term use of lubiprostone. Analyses of shifts in laboratory values (low/normal/high) at baseline and final assessment showed minimal effects on electrolytes, BUN, and creatinine. Lubiprostone did not cause clinically meaningful electrolyte imbalances or affect markers of renal function in either the short-term or long-term treatment of CIC or OIC. Copyright © 2021 The Author(s). Published by Wolters Kluwer Health, Inc.

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