Table 2.
PDSS total and domain scores from baseline to week 18 of advanced PD patients with sleep disturbances
| PDSS | PPX SR, n=49 | PPX IR, n=59 | ||
|---|---|---|---|---|
| Baseline | 18 weeks | Baseline | 18 weeks | |
| PDSS total score | 65.4±14.5 | 95.0±25.4 | 72.8±14.9 | 91.5±24.4 |
| Adjusteda mean changeb | 28.5 | 21.7 | ||
| SR versus IR, P-value (95% CI) | 6.8, P=0.1650 (−2.8 to 16.3) | |||
| PDSS domains | ||||
| Nocturnal motor symptoms | 14.7±8.1 | 25.6±8.1 | 18.7±8.1 | 25.6±7.7 |
| Adjusteda mean changeb | 9.6 | 8.9 | ||
| SR versus IR, P-value (95% CI) | 0.8, P=0.6422 (−2.5 to 4.0) | |||
| Global quality of sleep | 18.2±6.5 | 25.3±9.5 | 19.3±6.7 | 23.6±8.9 |
| Adjusteda mean changeb | 6.6 | 4.3 | ||
| SR versus IR, P-value (95% CI) | 2.3, P=0.1790 (−1.1 to 5.7) | |||
| Nocturnal psychosis | 11.9±4.9 | 15.2±4.1 | 12.5±4.4 | 13.9±4.7 |
| Adjusteda mean changeb | 3.1 | 1.5 | ||
| SR versus IR, P-value (95% CI) | 1.6, P=0.0547 (−0.0 to 3.2) | |||
| Nocturnal restlessness | 7.1±4.7 | 12.1±5.9 | 7.5±4.2 | 11.8±4.8 |
| Adjusteda mean changeb | 4.7 | 4.3 | ||
| SR versus IR, P-value (95% CI) | 0.4, P=0.7177 (−1.6 to 2.3) | |||
| Daytime sleepiness | 5.3±2.9 | 6.2±3.2 | 5.8±3.1 | 6.0±3.4 |
| Adjusteda mean changeb | 1.5 | 1.0 | ||
| SR versus IR, P-value (95% CI) | 0.5, P=0.4544 (−0.8 to 1.7) | |||
| Nocturia | 8.2±4.5 | 10.6±4.3 | 9.0±4.5 | 10.5±4.7 |
| Adjusteda mean changeb | 2.6 | 2.1 | ||
| SR versus IR, P-value (95% CI) | 0.6, P=0.5020 (−1.1 to 2.2) | |||
Notes:
a
Adjusted = Least-square means adjusted for pooled country and baseline scores;
b
positive change implies improvement. Data are presented as mean ± SD.
Abbreviations: IR, immediate release; PD, Parkinson’s disease; PDSS, Parkinson’s Disease Sleep Scale; PPX, pramipexole; SR, sustained release.