Table 3.
Complications of therapy (UPDRS IV), UPDRS-I, ADL and H&Y stage at baseline (before LCIG treatment) and at each follow-up visit, without LOCF
BL mean score ( ± SD) (Range) | N | Visit 2 | N | Visit 3 | N | Reduction at V3 vs BL | *p value at V2 vs BL **p value at V3 vs BL |
p ANOVA for repeated measures | |
---|---|---|---|---|---|---|---|---|---|
UPDRS IV total score (Items 32–42) | 8.2 (3.27) (0–18) | 134 | 4.7 (2.88) (0–14) | 124 | 4.9 (3.12) (0–14) | 112 | − 40% | * < 0.001 ** < 0.001 | < 0.001 |
Dyskinesia duration (Item 32) | 1.8 (1.04) (0–4) | 134 | 1.2 (0.89) (0–4) | 127 | 1.3 (1.02) (0–4) | 113 | − 28% | * < 0.001 ** < 0.001 | < 0.001 |
Dyskinesia disability (Item 33) | 1.5 (1.11) (0–4) | 133 | 0.9 (1.02) (0–4) | 124 | 0.9 (1.01) (0–4) | 112 | − 40% | * < 0.001 ** < 0.001 | < 0.001 |
Painful dyskinesia (Item 34) | 0.8 (0.97) (0–4) | 133 | 0.4 (0.69) (0–4) | 124 | 0.4 (0.73) (0–4) | 112 | − 50% | * < 0.001 ** < 0.001 | < 0.001 |
Presence of early morning dystonia (Item 35) | 58 (44%) (0–1) | 133 | 35 (28%) | 127 | 28 (25%) | 113 | − 43% | *0.002 ** < 0.001 | < 0.001 (Logit) |
OFF time duration (Item 39) | 2.0 (0.81) (0–4) | 137 | 0.9 (0.69) (0–3) | 127 | 1.0 (0.75) (0–3) | 114 | − 50% | * < 0.001 ** < 0.001 | < 0.001 |
UPDRS I total score | |||||||||
OFF | 6.8 (4.75) (0–16) | 79 | 5.9 (3.86) (0–16) | 81 | 6.0 (3.71) (1–16) | 65 | − 12% | *0.054 | 0.006 |
ON | 4.3 (3.08) (0–12) | 96 | 3.6 (2.71) (0–12) | 126 | 3.8 (2.78) (0–12) | 110 | − 12% | **0.055 | 0.008 |
UPDRS II (ADL) total score | |||||||||
OFF | 29.2 (9.63) (0–48) | 97 | 25.7 (8.49) (8–43) | 86 | 25.5 (8.76) (8–46) | 72 | − 13% | * < 0.001 **0.003 | < 0.001 |
ON | 18.2 (9.39) (0–39) | 111 | 16.2 (8.49) (1–43) | 127 | 16.2 (8.45) (1–34) | 109 | − 11% | *0.003 **0.078 | < 0.001 |
UPDRS V (Hoehn and Yahr) | |||||||||
OFF | 3.99 (0.82) (2–5) | 120 | 3.59 (0.85) (1–5) | 100 | 3.7 (0.81) (2–5) | 88 | − 7% | *< 0.001 **0.003 | < 0.001 |
ON | 3.07 (0.75) (1–5) | 135 | 2.72 (0.77) (0–5) | 128 | 2.77 (0.83) (0–5) | 115 | − 10% | * < 0.001 ** < 0.001 | < 0.001 |
ADL activities of daily living, BL baseline, LCIG levodopa/carbidopa intestinal gel, SD standard deviation; UPDRS, United Parkinson’s Disease Rating Scale