Efficacy and Safety of Oral Lubiprostone in the Management of Chronic Constipation

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  • 慢性便秘症に対するルビプロストンの効果と副作用の検討

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Abstract

This clinical study was performed to assess the efficacy and safety of lubiprostone in the treatment of chronic constipation in a general hospital. We prospectively enrolled 133 patients who received a 24 mcg lubiprostone capsule twice a day. All the patients had chronic constipation as defined by the Rome III criteria. Efficacy measures included change in constipation scoring system (CSS), incidence of treatment-related adverse events including nausea, and percentage of treatment discontinuation in the first two weeks after administration. The total score of CSS was significantly improved from 10.1 at baseline to 7.6 after 2 weeks. Among the 133 patients who took at least one dose of the study drug, 55 (41.4%) experienced at least one adverse event. Adverse events reported by ≥ 5% of patients overall were nausea (24.1%) and diarrhea (16.5%). Thirty-six patients (27.1%) withdrew from the study due to adverse events, of which 19 (14.3%) were due to nausea. The percentage of patients experiencing nausea was statistically and significantly higher among the women than the men. In conclusion, our results demonstrate that lubiprostone is effective in improving many chronic constipation related symptoms. Lubiprostone use is limited by the incidence of gastrointestinal side effects, most notably nausea.

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