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

Byron Cryer, Douglas A. Drossman, William D. Chey, Lynn Webster, Sepideh Habibi, Martin Wang

Research output: Contribution to journalArticle

7 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)1-11
Number of pages11
JournalDigestive Diseases and Sciences
DOIs
StateAccepted/In press - Aug 28 2017

Fingerprint

Constipation
Nausea
Opioid Analgesics
Placebos
Irritable Bowel Syndrome
Therapeutics
Clinical Studies
Lubiprostone
Incidence
Population

Keywords

  • Chronic idiopathic constipation
  • Irritable bowel syndrome with constipation
  • Lubiprostone
  • Nausea
  • Opioid-induced constipation

ASJC Scopus subject areas

  • Physiology
  • Gastroenterology

Cite this

Analysis of Nausea in Clinical Studies of Lubiprostone for the Treatment of Constipation Disorders. / Cryer, Byron; Drossman, Douglas A.; Chey, William D.; Webster, Lynn; Habibi, Sepideh; Wang, Martin.

In: Digestive Diseases and Sciences, 28.08.2017, p. 1-11.

Research output: Contribution to journalArticle

Cryer, Byron ; Drossman, Douglas A. ; Chey, William D. ; Webster, Lynn ; Habibi, Sepideh ; Wang, Martin. / Analysis of Nausea in Clinical Studies of Lubiprostone for the Treatment of Constipation Disorders. In: Digestive Diseases and Sciences. 2017 ; pp. 1-11.
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abstract = "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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AU - Cryer, Byron

AU - Drossman, Douglas A.

AU - Chey, William D.

AU - Webster, Lynn

AU - Habibi, Sepideh

AU - Wang, Martin

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N2 - 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.

AB - 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.

KW - Chronic idiopathic constipation

KW - Irritable bowel syndrome with constipation

KW - Lubiprostone

KW - Nausea

KW - Opioid-induced constipation

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