Table 2.
Men (N = 277) | Women (N = 146) | ||||||||||||||
Variable | Baseline (N = 277) | Month 12 (N = 261) | Month 24 (N = 248) | Month 36 (N = 239) | Month 48 (N = 230) | Month 60 (N = 210) | Baseline (N = 146) | Month 12 (N = 136) | Month 24 (N = 130) | Month 36 (N = 127) | Month 48 (N = 117) | Month 60 (N = 107) | p Interaction (Sex vs Time)** | p Time | Time effect |
MDS-UPDRS part III OFF | |||||||||||||||
Mean (SD) | 21.2 (9.1) | 25.6 (11.3) | 28.3 (11.6) | 29.9 (11.8) | 31.9 (11.7) | 32.3 (12.1) | 20.3 (8.5) | 24.0 (10.6) | 24.7 (10.1) | 27.8 (12.8) | 30.3 (13.5) | 28.9 (13.5) | 0.100 | < 0.001 | 2.72 |
Min–Max | 6.0–51.0 | 2.0–67.0 | 4.0–57.0 | 5.0–57.0 | 6.0–69.0 | 7.0–70.0 | 4.0–46.0 | 5.0–51.0 | 3.0–56.0 | 4.0–80.0 | 8.0–80.0 | 6.0–90.0 | |||
Missing | 0 | 41 | 58 | 66 | 62 | 56 | 0 | 24 | 36 | 43 | 36 | 33 | |||
MDS-UPDRS part III ON | |||||||||||||||
Mean (SD) | 21.2 (9.1) | 23.7 (11.2) | 24.6 (11.7) | 24.8 (11.8) | 25.1 (12.7) | 26.2 (13.3) | 20.3 (8.5) | 22.3 (10.2) | 20.4 (10.0) | 23.0 (13.0) | 22.7 (13.8) | 21.2 (12.8) | 0.010 | M: < 0.001 | M: 1.81 |
Min–Max | 6.0–51.0 | 2.0–67.0 | 0.0–68.0 | 1.0–59.0 | 1.0–69.0 | 3.0–85.0 | 4.0–46.0 | 1.0–48.0 | 0.0–49.0 | 0.0–65.0 | 1.0–7.0 | 0.0–68.0 | W: < 0.001 | W: 1.03 | |
Missing | 0 | 15 | 14 | 16 | 13 | 12 | 0 | 7 | 7 | 8 | 9 | 9 | |||
Hoehn and Yahr | |||||||||||||||
Stages 0–2 | 276 (100%) | 213 (97%) | 182 (96%) | 160 (92%) | 155 (92%) | 145 (94%) | 145 (99%) | 108 (95%) | 90 (95%) | 75 (89%) | 67 (83%) | 69 (92%) | 0.699 | < 0.001 | 0.71 |
Stages 3–5 | 1 (0%) | 7 (3%) | 8 (4%) | 13 (8%) | 14 (8%) | 10 (6%) | 1 (1%) | 6 (5%) | 5 (5%) | 9 (11%) | 14 (17%) | 6 (8%) | |||
Missing | 0 | 41 | 58 | 66 | 61 | 55 | 0 | 22 | 35 | 43 | 36 | 32 | |||
TD/non-TD classification | |||||||||||||||
TD | 199 (72%) | 150 (68%) | 126 (66%) | 106 (61%) | 106 (63%) | 94 (61%) | 100 (69%) | 73 (65%) | 62 (66%) | 55 (65%) | 45 (56%) | 38 (51%) | 0.646 | 0.038 | 0.93 |
Non-TD | 78 (28%) | 70 (32%) | 64 (34%) | 67 (39%) | 63 (37%) | 60 (39%) | 45 (31%) | 40 (35%) | 32 (34%) | 29 (35%) | 36 (44% | 36 (49%) | |||
Missing | 0 | 41 | 58 | 66 | 61 | 56 | 1 | 23 | 36 | 43 | 36 | 33 | |||
MDS-UPDRS part II | |||||||||||||||
Mean (SD) | 6.0 (4.3) | 7.9 (5.2) | 8.6 (5.3) | 9.6 (5.5) | 10.5 (6.5) | 11.3 (7.0) | 5.7 (4.0) | 6.8 (4.8) | 6.8 (5.0) | 7.6 (5.9) | 8.5 (6.9) | 7.9 (6.2) | < 0.001 | M: < 0.001 | M: 1.27 |
Min–Max | 0.0–20.0 | 0.0–36.0 | 0.0–36.0 | 1.0–29.0 | 0.0–37.0 | 0.0–40.0 | 0.0–22.0 | 0.0–25.0 | 0.0–27.0 | 0.0–29.0 | 0.0–36.0 | 0.0–39.0 | W: < 0.001 | W: 0.70 | |
Missing | 0 | 2 | 2 | 0 | 3 | 1 | 1 | 0 | 0 | 0 | 0 | 1 | |||
Modified Schwab &England Activities of Daily Living | |||||||||||||||
Mean (SD) | 93.0 (5.5) | 90.2 (6.7) | 88.3 (7.8) | 87.4 (7.6) | 85.4 (9.3) | 83.4 (13.1) | 93.5 (6.5) | 91.0 (6.8) | 89.7 (8.3) | 88.1 (9.0) | 86.3 (12.3) | 86.1 (13.0) | 0.428 | < 0.001 | –1.54 |
Min–Max | 80.0–100.0 | 70.0–100.0 | 60.0–100.0 | 60.0–100.0 | 50.0–100.0 | 10.0–100.0 | 70.0–100.0 | 70.0–100.0 | 60.0–100.0 | 50.0–100.0 | 20.0–100.0 | 20.0–100.0 | |||
Missing | 0 | 4 | 1 | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 2 | 1 | |||
LED | |||||||||||||||
Mean (SD) | NA | 297.6 (231.9) | 399.5 (307.4) | 501.8 (342.4) | 569.8 (332.9) | 668.0 (345.9) | NA | 320.6 (243.6) | 389.1 (321.4) | 439.4 (325.4) | 526.5 (362.8) | 574.9 (321.4) | 0.014 | M: < 0.001 | M: 104.62 |
Min–Max | 30.3–1,600.0 | 50.0–2,268.0 | 50–2,474.0 | 100–3,020 | 121.1–3,184.0 | 37.5–1,400 | 70–2,040 | 60.6–1,938 | 50–2,050 | 120–1,496 | W: < 0.001 | W: 78.08 | |||
Missing | 108 | 45 | 26 | 21 | 18 | 64 | 33 | 23 | 19 | 19 | |||||
LED-DA | |||||||||||||||
Mean (SD) | NA | 158.5 (84.5) | 178.9 (129.2) | 190.9 (110.6) | 201.6 (121.8) | 200.8 | NA | 161.9 (111.0) | 191.5 (129.0) | 174.0 (122.2) | 178.6 (11.71) | 173.9 (115.1) | 0.882 | 0.005 | 9.17 |
Min–Max | 30.3–450 | 5.0–825.0 | 5.0–480.0 | 5.0–600.0 | 20.0–600.0 | 12.5–450.0 | 40.0–675.0 | 5.0–675.0 | 25.0–675.0 | 37.5–675.0 | |||||
Missing | 201 | 201 | 164 | 148 | 136 | 106 | 90 | 65 | 65 | 63 |
All models are also adjusted for baseline BMI, LED, Vascular Risk Factor Score (VRF), and Side Most Affected. LED and LED-DA models only include baseline BMI, VRF Score, and Side Most Affected. Significance level for comparisons is p < 0.006 (after Bonferroni correction). **If interaction is significant, we find time effect p-values for men and women separately. Otherwise, we provide time effect p-value without stratifying by sex. LED, Levodopa equivalent dose; LED-DA, dopamine agonist levodopa equivalent dose; MDS-UPDRS, Movement Disorders Society-Unified Parkinson’s Disease Rating Scale: TD, tremor dominant.