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Tuesday Poster Session
Category: Functional Bowel Disease
Michael Camilleri, MD
Mayo Clinic
Rochester, MN, United States
Data: median (IQR), or number (%) | Eluxadoline, 100 mg BID |
Parameter | Cohort 1 with BAM | Cohort 2 without BAM |
Number in each cohort | 12 | 12 |
Demographics | ||
Age, years | 39.5 (37.0, 47.5) | 37.5 (33.0, 46.0) |
Gender (M=male, F=female) | 5M, 7F | 3M, 9F |
Race (W=white, B=Black or African American | 12W | 11W, 1B |
BMI, kg/m2 | 36.34 (31.81, 40.75) | 28.85 (24.06, 31.16) |
Number with history of anxiety/depression/panic disorder at baseline | 5 | 6 |
Bowel Functions | ||
BSFS baseline | 5.96 (5.54, 6.11) | 5.96 (5.54, 6.11) |
BSFS average over Rx period | 4.44 (3.83, 5.46) | 4.30 (3.73, 4.73) |
Change in BSFS on Rx minus baseline | -1.08 (-1.70, -0.57) | -1.09 (-1.86, -0.72) |
Daily BM frequency at baseline | 3.23 (1.93, 5.29) | 2.81 (1.99, 3.25) |
Change in daily BM frequency average on Rx minus baseline | -0.84 (-2.21, -0.41) | -0.80 (-0.99, -0.44) |
Daily urgent BM frequency at baseline | 1.43 (0.63, 2.65) | 0.96 (0.85, 1.42) |
Change in daily urgent BM frequency average on Rx minus baseline | -0.31 (-0.79, -0.18) | -0.69 (-0.99, -0.53) |
Number with experience of fecal incontinence during baseline | 3 (25%) | 3 (25%) |
Number with experience of fecal incontinence on Rx | 4 (33%) | 4 (33%) |
Scores of Worst Daily Abdominal Pain and Bloating | ||
Worst daily abdominal pain average score at baseline | 1.17 (0.61, 2.54) | 1.08 (0.82, 2.62) |
Change in worst daily abdominal pain average score on Rx minus baseline | 0.00 (-0.68, 0.46) | -1.22 (-1.65, -0.44) |
Worst daily abdominal bloating average score at baseline | 1.00 (0.46, 4.83) | 3.30 (2.35, 6.12) |
Change in worst daily bloating average score on Rx minus baseline | -0.40 (-1.57, 0.48) | -1.04 (-2.31, -0.35) |
Quality of Life | ||
IBS-QoL total score at baseline | 78.3 (65.8, 87.1) | 74.3 (61.0, 77.9) |
Change in IBS-QoL score on Rx minus baseline | 5.9 (2.6, 10.3) | 13.6 (5.1, 17.6) |
Serum 7αC4 (ng/mL) | ||
Serum 7αC4 baseline | 39.95 (23.25, 58.60) | 30.30 (20.2, 36.50) |
Serum 7αC4 at end of Rx | 29.30 (16.50, 64.20) | 20.05 (13.20, 26.40) |
Change in serum 7αC4 at end of Rx minus baseline | -1.40 (-22.50, 12.70) | -8.20 (-18.10, -0.80) |
Pharmacokinetics: plasma parameters expressed as mean (% coefficient of variation) | ||
Cmax (ng/mL) | 1.40 (96) | 0.91 (88) |
Tmax (hr) median (minimum, maximum) | 1.50 (1.00, 2.50) | 2.00 (1.00, 3.00) |
AUCtau (hr*ng/mL) | 9.22 (92) | 7.75 (109) |