Lubiprostone increases spontaneous bowel movement frequency and quality of life in patients with chronic idiopathic constipation.

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.

• Authors: Shin Fukudo, Michio Hongo, Hiroshi Kaneko, Masahiro Takano, Ryuji Ueno
• Journal: Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association (Clin Gastroenterol Hepatol) Vol. 13 Issue 2 Pg. 294-301.e5 (Feb 2015) ISSN: 1542-7714 [Electronic] United States
• PMID: 25158925 (Publication Type: Journal Article, Randomized Controlled Trial)
• Copyright: Copyright © 2015 AGA Institute. Published by Elsevier Inc. All rights reserved.

Chemical References

• Gastrointestinal Agents
• Placebos
• Lubiprostone

Topics

• Adult
• Aged
• Aged, 80 and over
• Constipation (drug therapy)
• Double-Blind Method
• Female
• Gastrointestinal Agents (administration & dosage)
• Gastrointestinal Motility (drug effects)
• Humans
• Intestines (drug effects, physiology)
• Japan
• Lubiprostone (administration & dosage)
• Male
• Middle Aged
• Placebos (administration & dosage)
• Quality of Life
• Treatment Outcome
• Young Adult