From: Indirect tolerability comparison of Deutetrabenazine and Tetrabenazine for Huntington disease
Before Matching | Before Matchinga | After Matching | After Matchinga | |||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
First-HD | TETRA-HD | First-HD | TETRA-HD | |||||||||
Baseline Characteristics, Mean (SD) | DTB (n = 45) | PBO (n = 45) | TBZ (n = 54) | PBO (n = 30) | p-value Active | p-value PBO | DTB (n = 45) | PBO (n = 45) | TBZ (n = 54) | PBO (n = 30) | p-value Active | p-value PBO |
Age | 55.4 (10.3) | 52.1 (13.4) | 49.4 (12.4) | 48.8 (10.5) | 0.009 | 0.231 | 49.4 (14.3) | 48.8 (12.3) | 49.4 (12.4) | 48.8 (10.5) | 1.000 | 1.000 |
CAG repeat length | 43.4 (2.7) | 44.3 (4.4) | 44.9 (3.4) | 44.3 (3.7) | 0.013 | 0.972 | 44.9 (4.1) | 45.6 (4.6) | 44.9 (3.4) | 44.3 (3.7) | 0.997 | 0.219 |
Gender, % | ||||||||||||
Female | 51.1 | 37.8 | 61.1 | 63.3 | 0.318 | 0.030 | 45.7 | 43.6 | 61.1 | 63.3 | 0.318 | 0.123 |
Male | 48.9 | 62.2 | 38.9 | 36.7 | 0.318 | 0.030 | 54.3 | 56.4 | 38.9 | 36.7 | 0.318 | 0.123 |
Caucasian, % | 100.0 | 84.4 | 92.6 | 96.7 | 0.062 | 0.093 | 100.0 | 80.0 | 92.6 | 96.7 | 0.040 | 0.035 |
UHDRS TMCb (lower score indicates lower severity) | 12.1 (2.7) | 13.2 (3.5) | 14.7 (3.8) | 15.2 (4.4) | <0.001 | 0.041 | 14.7 (2.9) | 15.2 (3.7) | 14.7 (3.8) | 15.2 (4.4) | 1.000 | 1.000 |
UHDRS TMSb (lower score indicates lower severity) | 34.1 (13.2) | 38.8 (15.2) | 47.0 (16.7) | 44.8 (15.5) | <0.001 | 0.099 | 41.4 (13.4) | 46.7 (16.8) | 47.0 (16.7) | 44.8 (15.5) | 0.201 | 0.677 |
Parkinsonism (lower score indicates lower severity) | 9.3 (4.7) | 11.7 (5.6) | 13.8 (5.7) | 12.8 (5.1) | <0.001 | 0.367 | 12.1 (5.3) | 14.3 (6.0) | 13.8 (5.7) | 12.8 (5.1) | 0.338 | 0.334 |
Gait (lower score indicates lower severity) | 1.0 (0.7) | 1.3 (0.7) | 1.2 (0.6) | 1.0 (0.5) | 0.176 | 0.058 | 1.5 (0.6) | 1.5 (0.7) | 1.2 (0.6) | 1.0 (0.5) | 0.060 | 0.003 |
Verbal fluency (higher score reflects better cognitive ability) | 25.2 (11.4) | 23.3 (9.9) | 18.9 (9.1) | 18.7 (10.8) | 0.003 | 0.064 | 20.9 (8.3) | 21.6 (8.0) | 18.9 (9.1) | 18.7 (10.8) | 0.312 | 0.209 |
Symbol digit (higher score reflects better cognitive ability) | 23.3 (8.7) | 23.4 (8.1) | 18.1 (11.5) | 24.4 (11.3) | 0.011 | 0.689 | 23.2 (9.8) | 20.8 (7.8) | 18.1 (11.5) | 24.4 (11.3) | 0.097 | 0.140 |
Stroop testc (higher score reflects better cognitive ability) | ||||||||||||
Color naming | 48.0 (16.9) | 44.5 (13.9) | 42.4 (14.3) | 46.7 (16.4) | 0.077 | 0.540 | 43.9 (15.2) | 41.8 (11.7) | 42.4 (14.3) | 46.7 (16.4) | 0.735 | 0.169 |
Word reading | 65.9 (22.4) | 55.7 (17.5) | 53.8 (21.0) | 56.3 (20.2) | 0.006 | 0.896 | 63.1 (23.2) | 52.7 (15.7) | 53.8 (21.0) | 56.3 (20.2) | 0.224 | 0.419 |
Behavioral assessment (lower score indicates less impairment) | 12.1 (12.4) | 9.6 (10.1) | 7.4 (7.3) | 6.6 (6.2) | 0.025 | 0.106 | 9.3 (10.5) | 7.8 (9.5) | 7.4 (7.3) | 6.6 (6.2) | 0.475 | 0.517 |
Functional checklist | 21.6 (3.0) | 20.8 (3.0) | 18.8 (4.4) | 19.6 (3.8) | <0.001 | 0.130 | 19.8 (3.4) | 19.9 (3.0) | 18.8 (4.4) | 19.6 (3.8) | 0.378 | 0.707 |
Independence scale (higher score indicates greater independence) | 85.0 (9.4) | 82.0 (9.3) | 76.9 (11.6) | 80.2 (9.4) | <0.001 | 0.414 | 80.3 (8.2) | 79.3 (7.7) | 76.9 (11.6) | 80.2 (9.4) | 0.172 | 0.670 |
Total functional capacity (higher scores indicate better capacity) | 9.8 (2.3) | 9.2 (2.0) | 8.3 (2.4) | 8.6 (2.3) | 0.001 | 0.280 | 8.3 (2.0) | 8.6 (1.8) | 8.3 (2.4) | 8.6 (2.3) | 1.000 | 1.000 |
Epworth Sleepiness Scale (lower score indicates less daytime sleepiness) | 4.6 (3.1) | 5.4 (3.8) | 3.4 (3.3) | 4.4 (3.5) | 0.073 | 0.220 | 6.2 (3.1) | 4.8 (3.1) | 3.4 (3.3) | 4.4 (3.5) | 0.001 | 0.614 |
Barnes Akathisia Rating Scale (higher scores indicate more akathisia and restlessness) | 1.4 (1.6) | 1.2 (1.9) | 0.3 (0.7) | 0.2 (0.6) | <0.001 | 0.001 | 0.8 (1.4) | 1.0 (1.8) | 0.3 (0.7) | 0.2 (0.6) | 0.079 | 0.020 |
UPDRS speech (lower score indicates less impairment) | 0.7 (0.8) | 1.0 (0.8) | 1.3 (0.6) | 1.1 (0.7) | <0.001 | 0.653 | 1.1 (0.7) | 1.2 (0.7) | 1.3 (0.6) | 1.1 (0.7) | 0.294 | 0.538 |