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Drug brings relief for many IBS patients who experience constipation
Date:5/18/2008

e participants more than 80 percent in most cases, Chey estimates.

Although AMITIZA is only approved for use in women with IBS-C, it doesnt mean that the drug doesnt work for men. Unfortunately, we just havent had enough men represented in these studies to make a firm decision on treatment using this drug, notes Chey.

The supplemental New Drug Application for AMITIZA which also is approved by the FDA for treatment of chronic idiopathic constipation was based on two phase III, multi-center trials involving 1,154 participants. These trials compared lubiprostone versus a placebo during the course of 12 weeks. Each participant kept an electronic diary to report weekly outcomes of IBS-C symptoms.

After one week, 20 percent of the lubiprostone participants reported moderate to significant relief of symptoms. By week four, 32 percent said they experienced relief of global IBS-C symptoms abdominal pain, bloating, constipation severity and straining during bowel movements. Lubiprostone also improved stool consistency.

Additionally, Chey will present findings at DDW from a follow-on study related to the two phase III trials. This 48-week study looked at the efficacy and safety of lubiprostone. Many of its 476 participants also took part in the phase III trials. For this study, however, participants all received lubiprostone; no placebos were given.

The study found that lubiprostone is effective and well tolerated in adults with IBS-C for up to one year. The spectrum of symptoms that constitute IBS-C, including abdominal pain and discomfort, bloating and constipation-related complaints, significantly improved during the 48-week treatment period. The most common treatment-related adverse events among the study groups were nausea and diarrhea.


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Contact: Krista Hopson
khopson@umich.edu
734-764-2220
University of Michigan Health System
Source:Eurekalert

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