Analysis of Nausea in Clinical Studies of Lubiprostone for the Treatment of Constipation Disorders

Cryer B1, Drossman DA2, Chey WD3, Webster L4, Habibi S5, Wang M6. Dig Dis Sci. 2017 Aug 28. doi: 10.1007/s10620-017-4680-1. [Epub ahead of print]
Author information

1 Internal Medicine, Veterans Affairs North Texas Health Care System, University of Texas Southwestern Medical School, 5323 Harry Hines Blvd, Dallas, TX, 75390, USA. Byron.cryer@UTSouthwestern.edu. 2 UNC Center for Functional GI and Motility Disorders, University of North Carolina at Chapel Hill, 55 Vilcom Center Drive, Suite 110, Chapel Hill, NC, 27514, USA. 3 Internal Medicine, University of Michigan School of Medicine, 3912 Taubman Center SPC 5362, Ann Arbor, MI, 48109, USA. 4 PRA Health Sciences, 3838 S 700 E Suite 202, Salt Lake City, UT, 84106, USA. 5 Drug Safety, Sucampo Pharma Americas, LLC, 4520 East-West Highway, Bethesda, MD, 20814, USA. 6 Biostatistics, Sucampo Pharma Americas, LLC, 4520 East-West Highway, Bethesda, MD, 20814, USA.


BACKGROUND: Lubiprostone is a ClC-2 chloride channel activator approved for the treatment of chronic idiopathic constipation (CIC) and opioid-induced constipation (OIC) in adults and irritable bowel syndrome with constipation (IBS-C) in women. Lubiprostone is generally well tolerated, with nausea being the most common adverse event.

AIMS: To characterize nausea with lubiprostone using pooled results from clinical studies in patients with CIC, OIC, or IBS-C.

METHODS: Data from three 3- and 4-week placebo-controlled studies and three long-term open-label studies were pooled for the CIC analysis. The OIC and IBS-C analyses each used pooled data from three 12-week placebo-controlled studies and one 36-week open-label extension study.

RESULTS: The populations included the following numbers of patients: CIC, 316 (placebo) and 1113 (lubiprostone 24 mcg twice daily [BID]); OIC, 652 (placebo) and 889 (lubiprostone 24 mcg BID); and IBS-C, 435 (placebo) and 1011 (lubiprostone 8 mcg BID). The incidence of nausea in lubiprostone-treated patients ranged from 11.4 to 31.1%, with the highest incidence in patients with CIC. Among patients with any nausea, most reported only mild or moderate severity (96.5-99.1% across indications) and only one event (83.6-88.7%); most events occurred within the first 5 days of treatment.

CONCLUSIONS: Nausea was the most common adverse event following the treatment with lubiprostone. Event rates varied by indication and dose, and the majority of nausea adverse events were mild to moderate in severity. Nausea events predominantly occurred early in the treatment period in all of the pooled study populations.

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