Lubiprostone increases spontaneous bowel movement frequency and quality of life in patients with chronic idiopathic constipation.
Clin Gastroenterol Hepatol
; 13(2): 294-301.e5, 2015 Feb.
Article
in En
| MEDLINE
| ID: mdl-25158925
ABSTRACT
BACKGROUND & AIMS:
Lubiprostone is an activator of the type 2 chloride channel that facilitates spontaneous bowel movement (SBM). We performed phase 3 studies to determine whether lubiprostone increases the frequency of SBM in patients with chronic idiopathic constipation (CIC) in Japan, and whether long-term administration of lubiprostone increases the quality of life of patients with CIC.METHODS:
We performed a randomized, double-blind, placebo-controlled, phase 3 trial of lubiprostone. Patients with CIC (n = 124) were assigned randomly to groups given placebo (n = 62) or lubiprostone (48 µg/day; n = 62) for 4 weeks. The primary efficacy end point was the change from baseline in the weekly average number of SBMs after 1 week of administration. In a long-term study of efficacy and safety, 209 patients with CIC were given lubiprostone (24 µg twice daily) for 48 weeks.RESULTS:
Daily administration of lubiprostone induced a significantly greater change, from baseline, in the weekly average number of SBMs at week 1 (increase of 3.7 ± 2.8), compared with placebo (increase of 1.3 ± 1.8; P < .001). The frequency of SBMs during each week of the study period was significantly higher after subjects began receiving lubiprostone than at baseline (P < .0001 at all weeks). Long-term administration of lubiprostone significantly increased scores from the Short-Form health survey and irritable bowel syndrome quality-of-life questionnaire, compared with baseline. We did not observe any severe adverse reactions to lubiprostone.CONCLUSIONS:
In phase 3 studies in Japan, lubiprostone increased the weekly average number of SBMs and increased the quality of life of patients with CIC. Clinical Trial Notification of the Japanese Regulatory Authorities 20-3296 and 20-3300.Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Gastrointestinal Agents
/
Constipation
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Lubiprostone
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Gastrointestinal Motility
/
Intestines
Type of study:
Clinical_trials
Limits:
Adult
/
Aged
/
Aged80
/
Female
/
Humans
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Male
/
Middle aged
Country/Region as subject:
Asia
Language:
En
Journal:
Clin Gastroenterol Hepatol
Journal subject:
GASTROENTEROLOGIA
Year:
2015
Type:
Article