Table 4.
Results of secondary analyses and endpoints in the PP population
| Lubiprostone sprinkle (n = 234) | Lubiprostone capsule (n = 113) | Placebo (n = 126) | ||||
|---|---|---|---|---|---|---|
| Baseline | Week 1 | Baseline | Week 1 | Baseline | Week 1 | |
| Superiority vs placebo in SBM count | ||||||
| Mean SBM count (SD) | 1.37 (0.693) | 4.82 (3.658) | 1.35 (0.720) | 5.74 (3.786) | 1.38 (0.692) | 3.68 (2.164) |
| Comparison vs PBO ANCOVA | P = 0.0020 | P < 0.0001 | ||||
| Comparison vs PBO van Elteren | P = 0.0143 | P < 0.0001 | ||||
| Observed frequency: mean and change from baseline | ||||||
| Mean SBM count (SD) | 1.37 (0.693) | 3.45 (3.572) | 1.35 (0.720) | 4.40 (3.805) | 1.38 (0.692) | 2.31 (2.178) |
| Change from baseline: 90% CI on sprinkle/capsule ratio of means | 0.527, 0.873 | |||||
| Frequency rate: mean and change from baseline | ||||||
| Mean SBM frequency rate (SD) | 1.43 (0.719) | 4.99 (3.693) | 1.40 (0.746) | 5.96 (3.847) | 1.46 (0.739) | 3.81 (2.253) |
| 90% CI on sprinkle/capsule ratio of means | 0.531, 0.871 | |||||
| Stool consistency: mean scores and changes from baseline | ||||||
| Mean consistency score (SD) | 2.39 (1.211) | 3.94 (1.516) | 2.28 (1.045) | 4.22 (1.409) | 2.47 (1.122) | 3.43 (1.270) |
| 90% CI on sprinkle/capsule ratio of means | 0.843, 0.995 | |||||
| Change from baseline: 90% CI on sprinkle/capsule ratio of means | 0.579, 0.938 | |||||
| Straining: mean scores and changes from baseline | ||||||
| Mean straining score (SD) | 2.31 (0.911) | 1.45 (0.937) | 2.40 (0.892) | 1.19 (0.917) | 2.39 (0.739) | 1.76 (0.871) |
| 90% CI on sprinkle/capsule ratio of means | 1.088, 1.600 | |||||
| Change from baseline: 90% CI on sprinkle/capsule ratio of means | 0.962, 1.174 | |||||
ANCOVA analysis of covariance, CI confidence interval, PBO placebo, PP per protocol, SBM spontaneous bowel movement, SD standard deviation