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Table 1 Baseline Characteristics and Baseline OHQ Scoresa

From: Integrated analysis of droxidopa trials for neurogenic orthostatic hypotension

Variable

Pooled Studies

Droxidopa

Placebo

Baseline characteristics

N

225

235

Male sex, n (%)

132 (58.7)

142 (60.4)

White race, n (%)

220 (97.8)

221 (94.0)

Mean ± SD age, y

65.0 ± 14.7

65.4 ± 14.6

Primary clinical diagnosis, n (%)

 Parkinson disease

150 (66.7)

157 (66.8)

 Pure autonomic failure

34 (15.1)

38 (16.2)

 Multiple system atrophy

31 (13.8)

25 (10.6)

 Nondiabetic autonomic neuropathy

4 (1.8)

9 (3.8)

 Dopamine ß-hydroxylase deficiency

0

1 (0.4)

 Other

6 (2.7)

5 (2.1)

Baseline OHQ scores

Mean ± SD OHQ composite score (n)

5.9 ± 1.7 (224)

5.8 ± 1.9 (232)

Mean ± SD OHSA scores, n

225

235

 Item 1

6.0 ± 2.2

5.8 ± 2.4

 Item 2

4.3 ± 2.9

3.7 ± 2.9

 Item 3

5.8 ± 2.5

5.6 ± 2.7

 Item 4

5.9 ± 2.4

5.9 ± 2.6

 Item 5

4.6 ± 2.7

4.7 ± 2.8

 Item 6

4.0 ± 3.2

4.4 ± 3.3

 Composite score

5.6 ± 1.7

5.5 ± 1.8

Mean ± SD OHDAS scores (n)

 Item 1

5.1 ± 2.8 (223)

5.3 ± 2.8 (230)

 Item 2

7.0 ± 2.4 (214)

6.9 ± 2.8 (229)

 Item 3

4.9 ± 2.9 (223)

4.7 ± 2.9 (228)

 Item 4

6.7 ± 2.8 (211)

6.6 ± 3.0 (223)

 Composite score

6.2 ± 2.0 (224)

6.1 ± 2.3 (231)

  1. OHDAS Orthostatic Hypotension Daily Activity Scale, OHQ Orthostatic Hypotension Questionnaire, OHSA Orthostatic Hypotension Symptom Assessment
  2. aOne patient was randomized to receive droxidopa but was erroneously administered placebo in Study NOH301; this patient was placed among placebo recipients for baseline characteristics and for safety assessments, and among droxidopa recipients for efficacy analyses.