Clinical trial: phase 2 trial of lubiprostone for irritable bowel syndrome with constipation.
02/15/08 11:20 AM
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Aliment Pharmacol Ther. 2008 Jan 28 [Epub ahead of print] Links Clinical trial: phase 2 trial of lubiprostone for irritable bowel syndrome with constipation.Johanson JF, Drossman DA, Panas R, Wahle A, Ueno R. University of Illinois College of Medicine, Rockford, Illinois, USA.
Background: Analyses of a trial in constipated patients indicated that lubiprostone may be an effective treatment for IBS-C. Aim: To assess efficacy and safety of 3 lubiprostone doses for IBS-C. Methods: 195 IBS-C patients received daily doses of 16 mcg (8 mcg twice daily [BID]), 32 mcg (16 mcg BID), or 48 mcg (24 mcg BID) lubiprostone or placebo BID for 3 months. Gastrointestinal parameters were recorded by patients in daily diaries. Results: After 1 month, lubiprostone showed significantly greater improvements in mean abdominal discomfort/pain scores vs. placebo (p=0.023). After 2 months, all lubiprostone groups showed significantly greater improvements in mean abdominal discomfort/pain scores (p</=0.039). After 3 months of treatment, the improvement in each lubiprostone arm was greater than placebo, but the test for trend was no longer significant. Treatment with lubiprostone showed significantly higher rates of gastrointestinal adverse events (AEs; p=0.020), especially diarrhea and nausea. Conclusion: Lubiprostone significantly improved gastrointestinal symptoms of IBS-C at all doses. Higher doses of lubiprostone, especially the 48 mcg/day group, were associated with more gastrointestinal AEs. From these data, the 16 mcg/day dose demonstrated the optimal combination of efficacy and safety. These results warrant further study of lubiprostone for treatment of IBS-C patients.
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Clinical trial: phase 2 trial of lubiprostone for irritable bowel syndrome with constipation.
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