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Effectiveness and safety of dexamphetamine sulfate (Attentin®) in the routine treatment of children and adolescents with ADHD: results from a 12-month non-interventional study

Henrik Uebel-von Sandersleben
Henrik Uebel-von Sandersleben
, 
Oliver Dangel
Oliver Dangel
, 
Roland Fischer
Roland Fischer
, 
Michaela Ruhmann
Michaela Ruhmann
 and 
Michael Huss
Michael Huss
   | Apr 23, 2021
Scandinavian Journal of Child and Adolescent Psychiatry and Psychology's Cover Image
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Published Online: Apr 23, 2021
Page range: 73 - 86
DOI: https://doi.org/10.21307/sjcapp-2021-009
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© 2021 Henrik Uebel-von Sandersleben et al., published by sciendo.
This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.

FIGURE 1.

Mean ADHD-RS-IV total scores from baseline to study end. Data are shown as mean ± SEM.
Mean ADHD-RS-IV total scores from baseline to study end. Data are shown as mean ± SEM.

FIGURE 2.

Overall burden of impairments in daily functioning during the study period. The proportions of patients at the respective visit are shown.
Overall burden of impairments in daily functioning during the study period. The proportions of patients at the respective visit are shown.

Subgroup analyses of ADHD-RS-IV total score changes during the study

Subgroup V1 (previous MPH treatment) Δ V2 – V1 Δ V3 – V1
N ADHD-RS-IV total score (mean ± SD) N ADHD-RS-IV total score (mean ± SD) p N ADHD-RS-IV total score (mean ± SD) p
Gender
    Male 98 27.6 ± 12.1 69 -12.8 ± 11.2 < .001 64 -13.3 ± 10.9 < .001
    Female 38 25.8 ± 10.8 27 -9.4 ± 9.3 < .001 21 -11.1 ± 10.8 < .001
Maximum total daily DEX dose (mg/d)
    ≤10 62 28.4 ± 10.8 46 -13.0 ± 11.0 < .001 40 -14.7 ± 11.2 < .001
    >10 to ≤20 51 28.2 ± 12.9 34 -10.4 ± 12.3 < .001 28 -11.3 ± 11.5 < .001
    >20 22 20.4 ± 9.8 16 -11.7 ± 4.7 < .001 17 -10.5 ± 8.5 < .001
Baseline ADHD-RS-IV total score
    ≤20 45 13.4 ± 3.0 40 -4.5 ± 8.7 .002 36 -5.1 ± 7.0 < .001
    >20 to ≤40 71 30.5 ± 5.1 41 -15.0 ± 7.9 < .001 37 -16.6 ± 9.3 < .001
    >40 20 45.7 ± 3.9 15 -22.8 ± 9.1 < .001 12 -23.8 ± 9.4 < .001

ADHD-RS-IV total and subscale score changes during the study and subgroup analyses stratified by age group (children and adolescents)

Subgroup V1 (previous MPH treatment) Δ V2 – V1 Δ V3 – V1
N Mean ± SD N Mean ± SD p N Mean ± SD p
Total population
ADHD-RS-IV total score 136 27.1 ± 11.7 96 -11.9 ± 10.8 < .001 85 -12.7 ± 10.9 < .001
ADHD-RS-IV subscale hyperactivity/impulsivity 136 11.1 ± 7.3 96 -5.0 ± 6.1 < .001 85 -5.7 ± 5.8 < .001
ADHD-RS-IV subscale inattention 136 16.0 ± 5.4 97 -6.8 ± 5.6 < .001 85 -7.1 ± 5.9 < .001
Subgroup analysis according to age group
ADHD-RS-IV total score
    Children 80 27.7 ± 12.9 58 -11.7 ± 11.7 < .001 54 -12.8 ± 11.3 < .001
    Adolescents 56 26.2 ± 9.8 38 -12.1 ± 9.3 < .001 31 -12.5 ± 10.3 < .001
ADHD-RS-IV subscale hyperactivity/impulsivity
    Children 80 11.8 ± 8.2 58 -5.0 ± 6.8 < .001 54 -6.0 ± 6.0 < .001
    Adolescents 56 10.0 ± 5.6 38 -5.1 ± 4.9 < .001 31 -5.1 ± 5.4 < .001
ADHD-RS-IV subscale inattention
    Children 80 15.9 ± 5.7 59 -6.7 ± 5.6 < .001 54 -6.9 ± 6.0 < .001
    Adolescents 56 16.1 ± 5.1 38 -7.0 ± 5.6 < .001 31 -7.4 ± 5.9 < .001

Baseline demographics and disease characteristics

Characteristic
Age (years)
  Mean ± SD 11.2 ± 3.1
  Median (minimum, maximum) 11.0 (6, 17)
Age group, n (%)
  Children (<12 years) 82 (58.6)
  Adolescents (≥12 years) 58 (41.4)
Race, n (%)
  White 140 (100.0)
Sex, n (%)
  Male 100 (71.4)
  Female 40 (28.6)
Time since ADHD diagnosis (months), median (IQR) (N=138) 22.0 (44.5)
ADHD diagnosis according to
  ICD-10 138 (98.6)
  DSM-5 1 (0.7)
  DSM-IV 1 (0.7)
ADHD diagnosis according to ICD-10, n (%)
  F90.0: disturbance of activity and attention 97 (69.3)
  F90.1: hyperkinetic conduct disorder 38 (27.1)
  F90.9: hyperkinetic disorder, unspecified 3 (2.1)
ADHD diagnosis according to DSM-5, n (%)
  314.01: combined presentation 1 (0.7)
ADHD diagnosis according to DSM-IV, n (%)
  314.01: predominantly hyperactive/impulsive type 1 (0.7)
Additional conduct disorder, n (%) 61 (43.6)
Concomitant diseases, n (%) (n≥3)
  All 53 (37.9)
  Autism spectrum disorder 9 (6.4)
  Disturbance in social behavior 7 (5.0)
  Depression 5 (3.6)
  Enuresis 4 (2.9)
  Sleep disorder 4 (2.9)
  Tic 3 (2.1)

Changes in height, weight, BMI z-scores and vital signs during the study

V1 V2 V3 Δ V2 – V1 Δ V3 – V1
N Mean ± SD N Mean ± SD N Mean ± SD N Mean ± SD p N Mean ± SD p
Height [cm] 140 147.7 ± 18.9 96 149.3 ± 17.1 86 151.8 ± 16.6 96 2.1 ± 2.1 < .001 86 5.7 ± 2.9 < .001
Weight [kg] 140 42.7 ± 17.7 97 41.6 ± 15.6 87 43.4 ± 15.7 97 1.2 ± 2.7 < .001 87 3.6 ± 3.7 < .001
BMI z-score 140 0.20 ± 1.20 96 -0.12 ± 1.08 86 -0.10 ± 1.11 96 -0.18 ± 0.49 < .001 86 -0.16 ± 0.63 0.018
Systolic blood pressure [mmHg] 140 112.1 ± 12.0 98 113.5 ± 11.9 87 114.3 ± 12.4 98 2.4 ± 9.6 0.017 87 3.8 ± 9.1 < .001
Diastolic blood pressure [mmHg] 140 71.5 ± 8.6 98 73.3 ± 8.4 87 74.7 ± 8.5 98 2.2 ± 8.8 0.016 87 3.8 ± 9.0 < .001
Heart rate [beats/min] 140 79.9 ± 13.7 98 78.4 ± 12.0 87 80.1 ± 13.1 98 0.01 ± 9.5 ns 87 0.64 ± 13.0 ns

Characteristics of treatment with previous MPH medications and DEX

Previous MPH treatment
Number of MPH therapies, n (%) (N=137)
    1 118 (86.1)
    2 15 (11.0)
    3 3 (2.2)
    5 1 (0.7)
Number of single doses per day, mean ± SD (N=137) 1.4 ± 0.5
    Immediate-release (N=33) 1.5 ± 0.6
    Extended-release (N=114) 1.4 ± 0.5
Total daily MPH dose (mg), mean ± SD (N=137) 27.5 ± 14.1
    Immediate-release (N=33) 20.7 ± 12.2
    Extended-release (N=114) 28.9 ± 14.0
DEX treatment
Total daily dose at the respective visit (mg), median (IQR)
    First titration visit (initial dose) (N=138) 5.0 (5.0)
        Children (<12 years) (N=80) 5.0 (5.0)
        Adolescents (≥12 years) (N=58) 5.0 (5.0)
    Titration (last recorded dose) (N=138) 11.3 (10.0)
        Children (<12 years) (N=80) 10.0 (10.6)
        Adolescents (≥12 years) (N=58) 15.0 (10.0)
    V2 (N=95) 12.5 (10.0)
        Children (<12 years) (N=57) 10.0 (10.0)
        Adolescents (≥12 years) (N=38) 15.0 (10.0)
    V3 (N=82) 15.0 (10.0)
        Children (<12 years) (N=53) 12.5 (10.0)
        Adolescents (≥12 years) (N=29) 20.0 (10.0)
Optimal total daily dose (mg), median (IQR) (N=120) 10.0 (10.0)
    Children (<12 years) (N=69) 10.0 (10.0)
    Adolescents (≥12 years) (N=51) 15.0 (10.0)
Optimal total daily dose per body weight (mg/kg), median (IQR) (N=120) 0.3 (0.3)
    Children (<12 years) (N=69) 0.4 (0.3)
    Adolescents (≥12 years) (N=51) 0.3 (0.2)
Number of titration steps to optimal total daily dose, n (%) (N=140)
    1 16 (11.4)
    2 46 (32.9)
    3 24 (17.1)
    4 22 (15.7)
    5 4 (2.9)
    6 7 (5.0)
    10 1 (0.7)
    Optimal total daily dose not achieved 18 (12.9)
    No titration performed 2 (1.4)
Dose regimen, n (%) (N=129)
    Once daily 76 (58.9)
    Twice daily 50 (38.8)
    Three times daily 2 (1.6)
    Four times daily 1 (0.8)
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