Table 1. Summary of patient demographic and baseline characteristics (ITT population).
| Placebo, N=395 | Linaclotide 290 μg, N=405 | |
|---|---|---|
| Demographic data | ||
| Age (years), mean (range) | 43.7 (18–84) | 43.3 (19–81) |
| ≥65 years, n (%) | 26 (6.6) | 19 (4.7) |
| Sex, n (%) | ||
| Female | 357 (90.4) | 367 (90.6) |
| Male | 38 (9.6) | 38 (9.4) |
| Race, n (%) | ||
| White | 301 (76.2) | 314 (77.5) |
| Black | 75 (19.0) | 78 (19.3) |
| Other | 19 (4.8) | 13 (3.2) |
| BMI, mean (s.d.) | 27.6 (6.2) | 28.3 (6.4) |
| Abdominal symptoms, mean (s.d.) | ||
| Abdominal paina | 5.6 (1.7) | 5.7 (1.7) |
| Abdominal discomforta | 6.0 (1.7) | 6.2 (1.6) |
| Abdominal bloatinga | 6.5 (1.9) | 6.7 (1.8) |
| Abdominal fullnessa | 6.5 (1.8) | 6.8 (1.7) |
| Abdominal crampinga | 5.4 (1.9) | 5.4 (1.9) |
| Bowel symptoms, mean (s.d.) | ||
| CSBMs/week | 0.2 (0.5) | 0.2 (0.5) |
| SBMs/week | 1.9 (1.4) | 1.9 (1.4) |
| Stool consistencyb | 2.4 (1.0) | 2.3 (1.0) |
| Strainingc | 3.4 (0.8) | 3.6 (0.8) |
| Constipation severityd | 3.7 (0.6) | 3.8 (0.6) |
| IBS severityd | 3.7 (0.6) | 3.7 (0.6) |
BMI, body mass index; CSBM, complete SBM; IBS, irritable bowel syndrome; ITT, intent-to-treat; SBM, spontaneous bowel movement.
Assessed using an 11-point Numerical Rating Scale: 0=none; 10=very severe.
Assessed using the BSFS: 1=separate hard lumps, like nuts (hard to pass); 2=sausage-shaped, but lumpy; 3=like a sausage but with cracks on its surface; 4=like a sausage or snake, smooth and soft; 5=soft blobs with clear cut edges (passed easily); 6=fluffy pieces with ragged edges, a mushy stool; 7=watery, no solid pieces (entirely liquid).
Assessed using a 5-point ordinal scale: 1=not at all; 2=a little bit; 3=a moderate amount; 4=a great deal; 5=an extreme amount.
Assessed using a 5-point ordinal scale: 1=none; 2=mild; 3=moderate; 4=severe; 5=very severe.
All demographic characteristics were similar between treatment groups. For baseline clinical characteristics, significant differences were observed for abdominal fullness (P=0.011), stool consistency (P=0.046), and straining (P=0.020).