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Table 1 Comparison of baseline characteristics in First-HD versus TETRA-HD

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

  1. DTB, deutetrabenazine, PBO placebo, SD standard deviation, TBZ tetrabenazine, TMC total maximal chorea, TMS total motor score, UHDRS Unified Huntington’s Disease Rating Scale, UPDRS Unified Parkinson's Disease Rating Scale. Bolded values indicate significant differences between the active arms (p < 0.05)
  2. a p-values are for the comparison between the respective arms (i.e. active vs active and placebo vs placebo) of the First-HD and TETRA-HD trials
  3. bIn First-HD, baseline was defined as Day 0 visit; the definition was not available in TETRA-HD
  4. cIn First-HD, the Stroop interference score was reported as the difference between the predicted and raw color–word score; however, TETRA-HD did not provide a definition of the reported Stroop interference score. It is possible that either the raw or the predicted color–word score was reported in TETRA-HD; therefore, the Stroop interference score was not included in this table