Table 2.
Baseline characteristics and demographic data (safety population)
| Characteristic | LDX (n = 128) | ATX (n = 134) |
|---|---|---|
| Demographic data | ||
| Age, years | ||
| Mean (SD) | 10.9 (3.01) | 10.4 (2.84) |
| Median (range) | 10.0 (6–17) | 10.0 (6–17) |
| Age distribution, years, n (%) | ||
| 6–12 | 94 (73.4) | 100 (74.6) |
| 13–17 | 34 (26.6) | 34 (25.4) |
| Male, n (%) | 94 (73.4) | 103 (76.9) |
| Ethnicity, n (%) | ||
| Hispanic or Latino | 25 (19.5) | 24 (17.9) |
| Not Hispanic or Latino | 103 (80.5) | 110 (82.1) |
| Race, n (%) | ||
| White | 116 (90.6) | 117 (87.3) |
| Height and weight | ||
| Height,a cm | ||
| Mean (SD) | 145.91 (17.446) | 144.12 (15.696) |
| Median (range) | 142.00 (113.3–187.4) | 143.25 (114.0–177.8) |
| Weight,a kg | ||
| Mean (SD) | 41.95 (16.521) | 39.14 (14.436) |
| Median (range) | 37.25 (22.9–88.0) | 35.65 (22.7–88.0) |
| BMI,a kg/m2 | ||
| Mean (SD) | 18.92 (3.551) | 18.21 (3.224) |
| Median (range) | 17.78 (13.4–31.3) | 17.51 (12.7–28.3) |
| Baseline disease characteristics | ||
| CGI-S score at baseline | ||
| Mean (SD) | 5.0 (0.80) | 5.0 (0.73) |
| Median (range) | 5.0 (3–7) | 5.0 (4–7) |
| ADHD-RS-IV total score at baseline | ||
| Mean (SD) | 42.6 (6.14)b | 41.9 (6.70)b |
| Median (range) | 42.0 (28–54) | 42.0 (28–53) |
| ADHD-RS-IV inattention subscale score at baseline | ||
| Mean (SD) | 22.6 (3.23) | 22.5 (3.12) |
| Median (range) | 23.0 (13–27) | 23.0 (11–27) |
| ADHD-RS-IV hyperactivity/impulsivity subscale score at baseline | ||
| Mean (SD) | 20.0 (4.68) | 19.4 (5.71) |
| Median (range) | 20.0 (6–27) | 20.0 (2–27) |
| ADHD subtype, n (%) | ||
| Predominantly inattentive | 22 (17.2) | 22 (16.4) |
| Predominantly hyperactive-impulsive | 2 (1.6) | 7 (5.2) |
| Combined | 104 (81.3) | 105 (78.4) |
| Time since ADHD diagnosis, years | ||
| Mean (SD) | 2.81 (2.746) | 2.11 (1.936) |
| Median (range) | 1.94 (0.0–12.9) | 1.57 (0.0–8.2) |
| Concomitant psychiatric diagnosis,c n (%) | ||
| Any | 27 (21.1) | 23 (17.2) |
| Oppositional defiant disorder | 13 (10.2) | 13 (9.7) |
| ADHD medication history | ||
| Previously treated with ADHD medication, n (%) | ||
| Any ADHD medication | 128 (100) | 134 (100) |
| Any methylphenidate medicationd | 127 (99.2) | 134 (100) |
| Reasons for inadequate response to methylphenidate,e n (%) | ||
| Lack of efficacy | 96 (75.0) | 106 (79.1) |
| Intolerability | 8 (6.3) | 8 (6.0) |
| Other | 42 (32.8) | 53 (39.6) |
ADHD attention-deficit/hyperactivity disorder, ADHD-RS-IV ADHD Rating Scale IV, ATX atomoxetine, BMI body mass index, CGI-S Clinical Global Impressions-Severity, LDX lisdexamfetamine dimesylate, SD standard deviation
aAs height was only measured at the screening visit, the values for height, weight (used to calculate BMI) and BMI are those obtained at screening
bThe observed baseline ADHD-RS-IV scores indicate moderate or severe illness [42]
cPatients with at least one ongoing psychiatric diagnosis, as determined by the Kiddie-Schedule for Affective Disorders and Schizophrenia for School Age Children—Present and Lifetime diagnostic interview
dMethylphenidate medication includes methylphenidate, methylphenidate hydrochloride, dexmethylphenidate and dexmethylphenidate hydrochloride. Patients may have received more than one type of ADHD medication but not more than one methylphenidate medication. One patient in the LDX group had not received any previous methylphenidate
ePatients may have listed more than one reason