Table 2. Changes from baseline in stool consistency and symptoms associated with treatment over the 12-week treatment perioda.
| Placebo (N=452) | Plecanatide 3 mg (N=453) | P valueb | Plecanatide 6 mg (N=441) | P valueb | |
|---|---|---|---|---|---|
| Stool consistency | |||||
| Baseline | 2.6 (1.1) | 2.5 (1.1) | – | 2.6 (1.2) | – |
| Change | 0.8 (0.1) | 1.5 (0.1) | <0.001 | 1.5 (0.1) | <0.001 |
| Daily symptoms scores | |||||
| Strainingc | |||||
| Baseline | 2.3 (0.8) | 2.3 (0.8) | – | 2.3 (0.9) | – |
| Change | −0.6 (0.0) | −0.9 (0.0) | <0.001 | −0.9 (0.0) | <0.001 |
| Abdominal bloatingc | |||||
| Baseline | 1.9 (0.9) | 1.9 (0.9) | – | 1.9 (1.0) | – |
| Change | −0.4 (0.0) | −0.5 (0.0) | 0.002 | −0.4 (0.0) | 0.045 |
| Abdominal discomfortc | |||||
| Baseline | 1.8 (0.9) | 1.8 (0.9) | – | 1.8 (0.9) | – |
| Change | −0.4 (0.0) | −0.5 (0.0) | <0.001 | −0.5 (0.0) | 0.014 |
| Patient global assessmentsd | |||||
| Constipation severitye | |||||
| Baseline | 3.5 (0.9) | 3.6 (0.9) | – | 3.5 (1.0) | – |
| Change | −1.0 (0.1) | −1.4 (0.1) | <0.001 | −1.4 (0.1) | <0.001 |
| Treatment satisfaction scoref | 2.8 (0.1) | 3.6 (0.1) | <0.001 | 3.5 (0.1) | <0.001 |
| Treatment continuation scoref | 3.4 (0.1) | 3.8 (0.1) | <0.001 | 3.8 (0.1) | <0.001 |
LS, least squares.
Baseline values are mean (s.d.). Change values are LS mean (s.e.).
P value compared with placebo group.
The severity of straining, bloating, and discomfort during bowel movements was assessed on a 5-point Likert scale where 0=none, 1=mild, 2=moderate, 3=severe, and 4=very severe.
Assessments at week 12.
Assessments of constipation severity: patients were asked to rate their constipation severity on a 1–5 scale, with a higher score indicating more severe constipation.
Assessments of treatment satisfaction and continuation: patients were asked to rate how satisfied they were with treatment on a 1–5 scale, with a higher score indicating higher satisfaction. The same scoring system was used for assessing treatment continuation. Values are mean (s.e.).