Long-term safety and effectiveness of lubiprostone, a chloride channel (ClC-2) activator, in patients with chronic idiopathic constipation

Anthony J. Lembo, John F. Johanson, Henry P. Parkman, Satish Sanku Chander Rao, Philip B. Miner, Ryuji Ueno

Research output: Contribution to journalArticle

54 Citations (Scopus)

Abstract

Background: Lubiprostone helps relieve constipation in short-term 4-week studies. There are limited data on long-term pharmacological treatment with lubiprostone for chronic idiopathic constipation. Aims: To examine the long-term safety and effectiveness of lubiprostone in patients with chronic idiopathic constipation. Methods: In this prospective, multicenter, open-labeled trial, 248 patients aged ≥18 years with chronic idiopathic constipation were directed to take lubiprostone 24 mcg BID as needed for 48 weeks. Patients were allowed to decrease the dose in response to the perceived severity of constipation and need for relief. Hematology and chemistry profiles and assessment of constipation symptoms and its severity were performed at all visits. Adverse events (AEs) were recorded. Results: Of the 248 patients who entered the trial, 127 (51%) completed the trial. A dose reduction was observed in 17% of the patients, resulting in an average study medication exposure across the study of approximately 1.7 capsules (or approximately 40.8 mcg) per day. The most common treatment-related AEs were nausea (19.8%), diarrhea (9.7%), abdominal distension (6.9%), headache (6.9%), and abdominal pain (5.2%). No deaths were reported and of the 16 reported serious AEs, one was considered possibly treatment related. Average changes in serum electrolytes were not clinically relevant at any time point during the study. On average, lubiprostone significantly (p < 0.0001) reduced patient-reported constipation severity, abdominal bloating, and abdominal discomfort across 48 weeks when compared to baseline. Conclusions: During this 48-week open-label study, lubiprostone was well tolerated. Bowel symptoms consistently improved over 48 weeks in adult patients with chronic idiopathic constipation.

Original languageEnglish (US)
Pages (from-to)2639-2645
Number of pages7
JournalDigestive Diseases and Sciences
Volume56
Issue number9
DOIs
StatePublished - Sep 1 2011
Externally publishedYes

Fingerprint

Constipation
Safety
Symptom Assessment
ClC-2 chloride channels
Lubiprostone
Hematology
Nausea
Abdominal Pain
Electrolytes
Capsules
Headache
Diarrhea
Therapeutics
Pharmacology
Serum

Keywords

  • Chronic idiopathic constipation
  • Effectiveness
  • Long-term safety
  • Lubiprostone

ASJC Scopus subject areas

  • Physiology
  • Gastroenterology

Cite this

Long-term safety and effectiveness of lubiprostone, a chloride channel (ClC-2) activator, in patients with chronic idiopathic constipation. / Lembo, Anthony J.; Johanson, John F.; Parkman, Henry P.; Rao, Satish Sanku Chander; Miner, Philip B.; Ueno, Ryuji.

In: Digestive Diseases and Sciences, Vol. 56, No. 9, 01.09.2011, p. 2639-2645.

Research output: Contribution to journalArticle

Lembo, Anthony J. ; Johanson, John F. ; Parkman, Henry P. ; Rao, Satish Sanku Chander ; Miner, Philip B. ; Ueno, Ryuji. / Long-term safety and effectiveness of lubiprostone, a chloride channel (ClC-2) activator, in patients with chronic idiopathic constipation. In: Digestive Diseases and Sciences. 2011 ; Vol. 56, No. 9. pp. 2639-2645.
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AU - Rao, Satish Sanku Chander

AU - Miner, Philip B.

AU - Ueno, Ryuji

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N2 - Background: Lubiprostone helps relieve constipation in short-term 4-week studies. There are limited data on long-term pharmacological treatment with lubiprostone for chronic idiopathic constipation. Aims: To examine the long-term safety and effectiveness of lubiprostone in patients with chronic idiopathic constipation. Methods: In this prospective, multicenter, open-labeled trial, 248 patients aged ≥18 years with chronic idiopathic constipation were directed to take lubiprostone 24 mcg BID as needed for 48 weeks. Patients were allowed to decrease the dose in response to the perceived severity of constipation and need for relief. Hematology and chemistry profiles and assessment of constipation symptoms and its severity were performed at all visits. Adverse events (AEs) were recorded. Results: Of the 248 patients who entered the trial, 127 (51%) completed the trial. A dose reduction was observed in 17% of the patients, resulting in an average study medication exposure across the study of approximately 1.7 capsules (or approximately 40.8 mcg) per day. The most common treatment-related AEs were nausea (19.8%), diarrhea (9.7%), abdominal distension (6.9%), headache (6.9%), and abdominal pain (5.2%). No deaths were reported and of the 16 reported serious AEs, one was considered possibly treatment related. Average changes in serum electrolytes were not clinically relevant at any time point during the study. On average, lubiprostone significantly (p < 0.0001) reduced patient-reported constipation severity, abdominal bloating, and abdominal discomfort across 48 weeks when compared to baseline. Conclusions: During this 48-week open-label study, lubiprostone was well tolerated. Bowel symptoms consistently improved over 48 weeks in adult patients with chronic idiopathic constipation.

AB - Background: Lubiprostone helps relieve constipation in short-term 4-week studies. There are limited data on long-term pharmacological treatment with lubiprostone for chronic idiopathic constipation. Aims: To examine the long-term safety and effectiveness of lubiprostone in patients with chronic idiopathic constipation. Methods: In this prospective, multicenter, open-labeled trial, 248 patients aged ≥18 years with chronic idiopathic constipation were directed to take lubiprostone 24 mcg BID as needed for 48 weeks. Patients were allowed to decrease the dose in response to the perceived severity of constipation and need for relief. Hematology and chemistry profiles and assessment of constipation symptoms and its severity were performed at all visits. Adverse events (AEs) were recorded. Results: Of the 248 patients who entered the trial, 127 (51%) completed the trial. A dose reduction was observed in 17% of the patients, resulting in an average study medication exposure across the study of approximately 1.7 capsules (or approximately 40.8 mcg) per day. The most common treatment-related AEs were nausea (19.8%), diarrhea (9.7%), abdominal distension (6.9%), headache (6.9%), and abdominal pain (5.2%). No deaths were reported and of the 16 reported serious AEs, one was considered possibly treatment related. Average changes in serum electrolytes were not clinically relevant at any time point during the study. On average, lubiprostone significantly (p < 0.0001) reduced patient-reported constipation severity, abdominal bloating, and abdominal discomfort across 48 weeks when compared to baseline. Conclusions: During this 48-week open-label study, lubiprostone was well tolerated. Bowel symptoms consistently improved over 48 weeks in adult patients with chronic idiopathic constipation.

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