TY - JOUR
T1 - Effects of Lubiprostone, an Intestinal Secretagogue, on Electrolyte Homeostasis in Chronic Idiopathic and Opioid-induced Constipation
AU - Rao, Satish S.C.
AU - Lichtlen, Peter
AU - Habibi, Sepideh
N1 - Funding Information:
This trial was sponsored by Sucampo Pharma Americas Inc. (now part of Mallinckrodt Pharmaceuticals), and Takeda Pharmaceuticals International Inc. This manuscript was supported by Sucampo Pharma Americas Inc. (now part of Mallinckrodt Pharmaceuticals), and Takeda Pharmaceuticals International Inc.
Funding Information:
The authors acknowledge Dr John F. Johanson, MD, MSc, FACP, FACG, for his contributions to the conception of the work and interpretation of data for this work. They acknowledge Martin Wang of Mallinckrodt Pharmaceuticals for his assistance with statistical analysis. Medical writing support was provided by Nikhilesh Sanyal, PhD, and Jacob Edelstein, PhD, of inVentiv Medical Communications, LLC, a Syneos Health group company, and was supported by Takeda Pharmaceuticals International.
Publisher Copyright:
© 2021 Lippincott Williams and Wilkins. All rights reserved.
PY - 2021/7
Y1 - 2021/7
N2 - Goals: To assess short-term and long-term effects of lubiprostone, a type-2 chloride channel activator, on electrolyte homeostasis. Background: 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. Study: 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. Results: 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. Conclusions: 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.
AB - Goals: To assess short-term and long-term effects of lubiprostone, a type-2 chloride channel activator, on electrolyte homeostasis. Background: 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. Study: 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. Results: 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. Conclusions: 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.
KW - chronic idiopathic constipation
KW - electrolyte homeostasis
KW - irritable bowel syndrome with constipation
KW - lubiprostone
KW - opioid-induced constipation
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U2 - 10.1097/MCG.0000000000001385
DO - 10.1097/MCG.0000000000001385
M3 - Article
C2 - 32569031
AN - SCOPUS:85093516331
SN - 0192-0790
VL - 55
SP - 512
EP - 519
JO - Journal of Clinical Gastroenterology
JF - Journal of Clinical Gastroenterology
IS - 6
ER -