Table 4. Completers Analysis of Primary (NIS+7) and Secondary Outcomes.
Data are Least Squares Means of change from baseline to 12 and 24 months for primary and secondary outcome measures by treatment groups, including 95% CI. The difference between treatment groups at 12 and 24 months is expressed as placebo-diflunisal LSM with 95% CI. Corresponding p values were calculated by ANCOVA models.
| Placebo Change from Baseline |
Diflunisal Change from Baseline |
Difference Placebo-Diflunisal Mean (95% CI) |
P-value | |||
|---|---|---|---|---|---|---|
| Characteristic | N | Mean (95% CI) | N | Mean (95% CI) | ||
| NIS+ND7 | ||||||
| Month 12 | 37 | 12.8 (8.9,16.7) | 50 | 6.3 (2.9,9.6) | 6.5 (1.4,11.7) | 0.013 |
| Month 24 | 28 | 20.1 (14.7,25.6) | 40 | 6.6 (2.0,11.1) | 13.5 (6.5,20.6) | <0.001 |
| NIS | ||||||
| Month 12 | 39 | 10.1 (6.9,13.3) | 50 | 4.1 (1.3,6.9) | 6.0 (1.7,10.2) | 0.006 |
| Month 24 | 30 | 18.9 (14.1,23.7) | 40 | 5.1 (0.9,9.2) | 13.8 (7.5,20.1) | <0.001 |
| NISLL | ||||||
| Month 12 | 39 | 6.1 (4.0,8.3) | 50 | 3.3 (1.4,5.2) | 2.8 (−0.1,5.7) | 0.055 |
| Month 24 | 30 | 9.9 (6.9,12.8) | 40 | 2.7 (0.2,5.3) | 7.1 (3.2,11.1) | <0.001 |
| Kumamoto Score | ||||||
| Month 12 | 38 | 4.4 (2.4,6.4) | 49 | 2.0 (0.2,3.8) | 2.4 (−0.3,5.1) | 0.082 |
| Month 24 | 29 | 6.6 (4.4,8.9) | 39 | 2.8 (0.9,4.7) | 3.9 (0.9,6.8) | 0.010 |
| mBMI | ||||||
| Month 12 | 40 | −46.6 (−82.2,−11.1) | 50 | −20.7 (−52.5,11.1) | −25.9 (−73.6,21.8) | 0.287 |
| Month 24 | 29 | −76.5 (−114.6,−38.4) | 39 | −25.7 (−58.5,7.2) | −50.8 (−101.1,−0.6) | 0.048 |
| SF36 Physical | ||||||
| Month 12 | 38 | −2.5 (−4.4,−0.6) | 50 | 0.4 (−1.2,2.1) | −2.9 (−5.4,−0.4) | 0.025 |
| Month 24 | 30 | −5.6 (−8.3,−2.9) | 38 | 1.3 (−1.1,3.7) | −6.9 (−10.5,−3.3) | <0.001 |
| SF36 Mental | ||||||
| Month 12 | 38 | 0.0 (−2.4,2.4) | 50 | 1.6 (−0.6,3.7) | −1.6 (−4.8,1.7) | 0.343 |
| Month 24 | 30 | −1.8 (−4.9,1.3) | 38 | 2.5 (−0.2,5.3) | −4.3 (−8.5,−0.2) | 0.040 |