Table 1.
Baseline demographic and clinical characteristics in two randomised, controlled studies of lubiprostone in patients with baseline SBM frequency <3/week (intent‐to‐treat populations)
| Study 1 | Study 2 | Pooled Studies | ||||
|---|---|---|---|---|---|---|
| Placebo (n = 88) | Lubiprostone (n = 170) | Placebo (n = 92) | Lubiprostone (n = 155) | Placebo (n = 180) | Lubiprostone (n = 325) | |
| Sex, n (%) | ||||||
| Female | 85 (96.6) | 161 (94.7) | 89 (96.7) | 143 (92.3) | 174 (96.7) | 304 (93.5) |
| Male | 3 (3.4) | 9 (5.3) | 3 (3.3) | 12 (7.7) | 6 (3.3) | 21 (6.5) |
| Mean (s.d.) age, years | 47.6 (12.4) | 45.8 (12.9) | 45.3 (12.0) | 44.8 (11.8) | 46.4 (12.2) | 45.4 (12.4) |
| Race/ethnicity, n (%) | ||||||
| White | 64 (72.7) | 117 (68.8) | 68 (73.9) | 112 (72.3) | 132 (73.3) | 229 (70.5) |
| Black/African American | 16 (18.2) | 28 (16.5) | 17 (18.5) | 33 (21.3) | 33 (18.3) | 61 (18.8) |
| Hispanic/Latino | 7 (8.0) | 25 (14.7) | 7 (7.6) | 10 (6.5) | 14 (7.8) | 35 (10.8) |
| Other | 1 (1.1) | 0 | 0 | 0 | 1 (0.6) | 0 |
| Mean (s.d.) abdominal discomfort/paina | 2.18 (0.69) | 2.27 (0.67) | 2.25 (0.63) | 2.14 (0.70) | 2.21 (0.66) | 2.21 (0.69) |
| Mean (s.d.) bloatinga | 2.37 (0.69) | 2.48 (0.69) | 2.40 (0.62) | 2.30 (0.74) | 2.39 (0.65) | 2.39 (0.72) |
| Mean (s.d.) SBM frequency/week | 1.49 (0.85) | 1.56 (0.91) | 1.32 (0.94) | 1.55 (0.87)b | 1.40 (0.90) | 1.56 (0.89) |
SBM, spontaneous bowel movement.
P values were calculated using a 2‐sample t‐test for continuous variables and a chi‐square test for categorical variables.
a
Scale from 0 (absent) to 4 (very severe).
b
P < 0.05 vs. placebo.