Amitiza lubiprostone: Phase III data

Data from 124 patients ages 3-17 years with functional constipation defined as <3 SBMs per week in an open-label Phase III trial showed that lubiprostone was well tolerated and increased SBM frequency. In children <6 years old, lubiprostone significantly improved mean SBM frequency from baseline by 1.69 at week 1, 1.41 at week 2, 1.17 at week 3 and 1.52 at week 4 (p<0.05 for all). In children ages 6-11 years weighing 12-23 kg, lubiprostone non-significantly improved mean SBM frequency from baseline by 0.34 at week 1, 1.26 at week 2 and 1.54 at week 3 and significantly improved SBM frequency from baseline by 1.56 at week 4 (p<0.05). In children ages 6-11 years weighing 24-35 kg, lubiprostone significantly improved mean SBM frequency from baseline by 1.33 at week 1, 1.78 at week 2, 1.62 at week 3 and 1.57 at week 4 (p<0.01 for all). In children ages 6-11 years weighing >=36 kg, lubiprostone improved mean SBM frequency from baseline by 1.91 at week 1 (p<0.01), 1.26 at week 2 (p<0.05), 0.65 at week 3 (p=not significant) and 0.93 at week 4 (p<0.01). In adolescents ages 12-17, lubiprostone significantly improved mean SBM frequency from baseline by 2.1 at week 1, 1.28 at week 2, 1.63 at week 3 and 1.24 at week 4 (p<0.01 for all). Patients received once- or twice-daily 12 µg lubiprostone or twice-daily 24 µg lubiprostone. Data were presented at the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition meeting in Chicago and published in the Journal of Pediatric Gastroenterology and Nutrition. ...