Efficacy results for fluctuating patients
| Entacapone (n=115) | Placebo (n=57) | ||||
|---|---|---|---|---|---|
| Variables | Baseline (n=115) | Mean, months 4 and 6 (n=80) | Baseline (n=57) | Mean, months 4 and 6 (n=44) | Entacapone v placebo* |
| Values are mean (SD). | |||||
| *Intention to treat-observed cases analysis. | |||||
| ADL, activities of daily living; UPDRS, unified Parkinson’s disease rating scale. | |||||
| Primary efficacy variable | |||||
| Home diary data | |||||
| Proportion ON time (%) | 57.6 (14.5) | 64.8 (14.0) | 59.3 (15.8) | 60.6 (16.7) | p<0.05 |
| Secondary efficacy variables | |||||
| Home diary data | |||||
| ON time (h) | 9.5 (2.5) | 10.8 (2.4) | 10.1 (2.8) | 10.2 (2.9) | p<0.01 |
| OFF time (h) | 7.0 (2.6) | 5.9 (2.5) | 6.9 (2.9) | 6.6 (2.8) | p<0.05 |
| Levodopa dose (mg/d) | 700 (429) | 667 (322) | 705 (368) | 731 (377) | p<0.001 |
| UPDRS | |||||
| Mentation, behaviour, mood (part I) | 1.7 (1.9) | 2.0 (2.2) | 1.4 (1.6) | 1.5 (1.7) | p<0.01 |
| ADL (part II) | 12.5 (5.7) | 12.0 (5.6) | 13.7 (6.9) | 12.6 (7.4) | NS |
| Motor score (part III) | 24.3 (12.2) | 19.8 (11.6) | 23.6 (12.6) | 19.3 (12.6) | NS |
| Total score (I, II, and III) | 38.4 (17.3) | 33.7 (17.0) | 38.7 (17.9) | 33.2 (20.0) | NS |
| Scheduled levodopa dose (mg/d) | 684 (393) | 667 (334) | 683 (356) | 705 (369) | p<0.001 |