Abstract

G A A b st ra ct s patients were re-assigned to LL (n=84) or LP (n=86) group. Mean changes from baseline at all treatment weeks were statistically significant in all treatment groups for stool consistency, abdominal discomfort/pain, and SBM frequency (p<0.003). L group had statistically significant improvement in stool consistency compared to P group in almost a half of the 12 weekly visits (p<0.03). Similar significant improvements were observed at Weeks 13, 14, and 15 for the LL group (p<0.05). L group had statistically significant mean reduction from baseline in abdominal discomfort/pain at Weeks 10 and 11 compared to P group (p<0.05). Significant results were further observed at Weeks 13, 15, and 16 for the LL group (p<0.04). These results were not seen in the LP group. The range of increase from baseline in SBM frequency at Period I was 2.1-2.9 and 1.4-2.5 for the L and P groups, respectively. LL group had a range of 2.6-3.2, whereas the range for LP group and P group were 2.0-2.7 and 2.12.5, respectively. CONCLUSION: Lubiprostone provided significant improvement in stool consistency, abdominal discomfort/pain, and SBM frequency for standard treatment of 12 weeks, and consistent results of all outcomes were observed during 16 weeks of treatment. Moreover, longer term treatment provided significant reduction in abdominal discomfort/ pain.

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