Efficacy and safety of lubiprostone for the treatment of functional constipation in Chinese adult patients: a multicenter, randomized, double-blind, placebo-controlled trial.

BACKGROUND AND AIMS Functional constipation is a functional gastrointestinal disorders prevalent around the world. Lubiprostone is the first locally acting type-2 chloride channel activator in the treatment of constipation. The current study aimed to determine the efficacy and safety of lubiprostone in Chinese functional constipation adult patients . METHODS This was a multicenter, randomized, double-blind, placebo-controlled study. Functional constipation patients were randomized to receive treatment of lubiprostone (48 mcg/ day) or placebo for 4 weeks. The primary endpoint was the frequency of spontaneous bowel movements (SBMs) during the first week of treatment. The secondary endpoints included the median time of the first SBM, SBMs frequency at weeks 2, 3 and 4, weekly response rate of SBMs, the stool consistency score and average number of complete spontaneous bowel movements (CSBMs) per week. RESULTS In total, 259 patients were randomized with 130 in lubiprostone group and 129 in placebo group. SBM frequency was higher in lubiprostone group (4.88±4.09 per week) than that in the placebo group (3.22±2.01 per week) at week 1 (p<0.0001). SBM frequency was also higher in lubiprostone group at week 2, 3 and 4. The average number of CSBMs and the stool consistency score in lubiprostone group were significantly higher than that in placebo group at each week. No drug-related serious adverse events (AEs) occurred. The most commonly reported AEs was nausea. CONCLUSIONS Lubiprostone was superior to placebo in treating Chinese functional constipation patients with good safety profile. This article is protected by copyright. All rights reserved.