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Cited by 110Gastrointestinal motility and disordersPelvic floor disorders treatmentsCongenital gastrointestinal and neural anomalies

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

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Fukudo, Shin, Hongo, Michio, Kaneko, Hiroshi, Takano, Masahiro, Ueno, Ryuji·2015·Clinical Gastroenterology and Hepatology
DOI 10.1016/j.cgh.2014.08.026
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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.

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  • Pooled data showed that lubiprostone resulted in an increased number of SBMs per week compared with placebo (MD 1.98, 95% CI 1.17-2.79).

    “The pooled data showed that lubiprostone resulted in an increased number of SBMs per week compared with placebo (MD 1.98, 95% CI 1.17-2.79).”

    From American Gastroenterological Association-American College of Gastroenterology Clinical Practice Guideline: Pharmacological Management of Chronic Idiopathic Constipation (2023) · cites this paper as [59]

    The Efficacy Results report that lubiprostone increased weekly spontaneous bowel movements more than placebo in study 1. However, the paper reports that trial’s results, not a pooled mean difference of 1.98 or the stated 95% confidence interval. Page numbers were not supplied in our copy. (LLM, conf=0.90)

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Research works printed but not linked: 7

  1. [3]3. Bharucha AE, Wald A, Enck P, et al. Functional anorectal dis- orders. Gastroenterology 2006;130:1510-1518.
  2. [28]28. Drossman DA, Chey WD, Johanson JF, et al. Clinical trial: lubiprostone in patients with constipation-associated irritable bowel syndrome-results of two randomized, placebo-controlled studies. Aliment Pharmacol Ther 2009;29:329-341.
  3. [29]29. Fukudo S, Hongo M, Kaneko H, et al. Efficacy and safety of oral lubiprostone in constipated patients with or without irritable bowel syndrome: a randomized, placebo-controlled and dose- finding study. Neurogastroenterol Motil 2011;23:544-e205.
  4. [30]30. Johanson JF, Morton D, Geenen J, et al. Multicenter, 4-week, double-blind, randomized, placebo-controlled trial of lubipro- stone, a locally-acting type-2 chloride channel activator, in pa- tients with chronic constipation. Am J Gastroenterol 2008;103: 170-177.
  5. [31]31. Barish C, Drossman D, Johanson J, et al. Efficacy and safety of lubiprostone in chronic constipation. Dig Dis Sci 2010;55: 1090-1097.
  6. [32]32. Whitehead WE, Levy RL, Von Korff M, et al. The usual medical care for irritable bowel syndrome. Aliment Pharmacol Ther 2004; 20:1305-1315.
  7. [33]33. International conference on harmonisation; guidance on statis- tical principles for clinical trials; availability-FDA. Notice. Fed Regist 1998;63:49583-49598. 301.e3 Fukudo et al Clinical Gastroenterology and Hepatology Vol. 13, No. 2

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Authors
Fukudo, S., Hongo, M., Kaneko, H., Takano, M., & Ueno, R.
Affiliations
  • Tohoku University (JP)
  • Takano Hospital (JP)
  • Sucampo (Switzerland) (CH)
Corresponding author
Fukudo, Shin
ORCID
Venue
Clinical Gastroenterology and Hepatology
Publisher
Elsevier BV
Published
2015-02
Volume
13
Issue
2
Pages
294-301.e5
ISSN
1542-3565 (ISSN-L)
DOI
10.1016/j.cgh.2014.08.026
OpenAlex
W1995874631
Cited by
110
References
28
Citations by year
2026: 1 · 2025: 7 · 2024: 14 · 2023: 11 · 2022: 6 · 2021: 7 · 2020: 17 · 2019: 11 · 2018: 9 · 2017: 10 · 2016: 9 · 2015: 7 · 2014: 1
FWCI
9.04
Type
journal article
Language
en
Open access
Licence
Locations
  • Clinical Gastroenterology and Hepatology (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Health Sciences › Medicine › Gastroenterology › Gastrointestinal motility and disorders
  • Health Sciences › Medicine › Rheumatology › Pelvic floor disorders treatments
  • Health Sciences › Medicine › Surgery › Congenital gastrointestinal and neural anomalies
Keywords
lubiprostone, chronic idiopathic constipation, quality of life, chloride channel activator, long-term drug safety, Short Form Health Survey
MeSH terms
Lubiprostone, Adult, Aged, Aged, 80 and over, Constipation, Double-Blind Method, Female, Gastrointestinal Agents, Gastrointestinal Motility, Humans, Intestines, Japan, Male, Middle Aged, Placebos, Quality of Life, Treatment Outcome, Young Adult

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