PTH-197 Long-Term Efficacy of Lubiprostone Demonstrated in Patients with Constipation Regardless of age, Gender or Race

Introduction Constipation affects millions globally and may require chronic treatment. In 24- and 48-week trials, lubiprostone demonstrated safety and efficacy in long-term treatment of adults with chronic idiopathic constipation. Analyses of lubiprostone’s (24 mcg BID) efficacy in age, gender and race subgroups were performed. Aims and Methods Pooled data from three Phase 3 open-label safety studies were reviewed to analyse efficacy in the following subpopulations: non-elderly (< 65 years) and elderly (≥65 years); male and female; and non-white and white. Constipation severity, abdominal bloating, and abdominal discomfort were rated on a 5-point scale ranging from absent = 0, mild = 1, moderate = 2, severe = 3 and very severe = 4, and changes from baseline following treatment with lubiprostone were analysed. Results In the non-elderly and elderly, lubiprostone improved constipation severity (p≤0.0001) each week beginning at Week 1 and continuing through Week 48. Among males and females, lubiprostone improved (p≤0.0001) constipation severity each week with similar findings (p≤0.0001) for non-whites and whites, For abdominal discomfort, significant changes were seen at all weeks in the non-elderly (p≤0.0001) and for all weeks in the elderly (p≤0.0001 to p = 0.0150) except Week 8 (p = 0.0530). Among the genders, improvements occurred at all weeks in males (p≤0.0001 to p = 0.0220) and in females (p≤0.0001). By race, improvements occurred at all weeks among non-whites (p≤0.0001 to p = 0.0020) and among whites (p≤0.0001). Significant changes in abdominal bloating were seen in the non-elderly (p≤0.0001) and for the elderly (p≤0.0001 to p = 0.0180) at all weeks. Abdominal bloating improved at all weeks for males (p≤0.0001 to p = 0.0010) and females (p≤0.0001). For non-whites and whites, abdominal bloating improved (p≤0.0001) at all weeks. Abstract PTH-197 Table 1 Change from Baseline for Constipation Severity Mean Change From Baseline Baseline Week 1 Week 12 Week 24 Week 36 Week 48 Age < 65 Years 2.91 -1.21 -1.18 -1.21 -1.19 -1.14 ≥65 years 2.76 -1.11 -0.97 -1.00 -1.15 -1.03 Gender Male 2.65 -1.21 -1.12 -1.18 -1.27 -1.17 Female 2.92 -1.19 -1.14 -1.17 -1.16 -1.11 Race Non-Whites 2.98 -1.52 -1.51 -1.52 -1.48 -1.38 Whites 2.87 -1.14 -1.08 -1.12 -1.13 -1.08 Conclusion Lubiprostone demonstrated long-term efficacy through an overall improvement in constipation severity for up to 12 months regardless of age, gender, or race. Similarly, improvements were noted in abdomin