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Drugs

, Volume 66, Issue 6, pp 873–879 | Cite as

Lubiprostone

  • Kate McKeage
  • Greg L. Plosker
  • M. Asif A. Siddiqui
Adis Drug Profile

Abstract

▴ Lubiprostone (Amitiza™) is an oral bicyclic fatty acid that selectively activates type 2 chloride channels in the apical membrane of the gastrointestinal epithelium, resulting in increased fluid secretion.

▴ In two pivotal, randomised, double-blind, multicentre phase III studies in patients with chronic idiopathic constipation, the frequency of spontaneous bowel movements (SBMs) was significantly greater in patients receiving lubiprostone 24µg twice daily than in those receiving placebo at each weekly timepoint throughout both 4-week studies (p < 0.05).

▴ At week 1 in one pivotal trial, the mean frequency of SBMs in the lubiprostone group was 5.9 per week compared with 4.0 per week in the placebo group (p < 0.0001) [baseline SBMs 1.3 and 1.5 per week].

▴ Significantly greater improvements occurred with lubiprostone than placebo in the degree of straining, stool consistency and constipation severity (where reported) in both pivotal studies (p < 0.05 for all comparisons at all timepoints).

▴ Lubiprostone was generally well tolerated in clinical trials with no reports of treatment-related serious adverse events in pivotal trials. Nausea was the most common adverse event, occurring in up to 31% of patients receiving lubiprostone.

Keywords

Chloride Channel Intestinal Fluid Pivotal Trial Stool Consistency Cystic Fibrosis Transmembrane Regulator 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

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Copyright information

© Adis Data Information BV 2006

Authors and Affiliations

  • Kate McKeage
    • 1
  • Greg L. Plosker
    • 1
  • M. Asif A. Siddiqui
    • 1
  1. 1.Adis International LimitedMairangi Bay, Auckland 1311New Zealand

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