Have a personal or library account? Click to login

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

Scandinavian Journal of Child and Adolescent Psychiatry and Psychology
Volume 9 (2021): Issue 1 (January 2021)
By:
Open Access
|Apr 2021

Figures & Tables

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

SubgroupV1 (previous MPH treatment)Δ V2 – V1Δ V3 – V1
NADHD-RS-IV total score (mean ± SD)NADHD-RS-IV total score (mean ± SD) p NADHD-RS-IV total score (mean ± SD) p
Gender
    Male9827.6 ± 12.169-12.8 ± 11.2< .00164-13.3 ± 10.9< .001
    Female3825.8 ± 10.827-9.4 ± 9.3< .00121-11.1 ± 10.8< .001
Maximum total daily DEX dose (mg/d)
    ≤106228.4 ± 10.846-13.0 ± 11.0< .00140-14.7 ± 11.2< .001
    >10 to ≤205128.2 ± 12.934-10.4 ± 12.3< .00128-11.3 ± 11.5< .001
    >202220.4 ± 9.816-11.7 ± 4.7< .00117-10.5 ± 8.5< .001
Baseline ADHD-RS-IV total score
    ≤204513.4 ± 3.040-4.5 ± 8.7.00236-5.1 ± 7.0< .001
    >20 to ≤407130.5 ± 5.141-15.0 ± 7.9< .00137-16.6 ± 9.3< .001
    >402045.7 ± 3.915-22.8 ± 9.1< .00112-23.8 ± 9.4< .001

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

SubgroupV1 (previous MPH treatment)Δ V2 – V1Δ V3 – V1
NMean ± SDNMean ± SD p NMean ± SD p
Total population
ADHD-RS-IV total score13627.1 ± 11.796-11.9 ± 10.8< .00185-12.7 ± 10.9< .001
ADHD-RS-IV subscale hyperactivity/impulsivity13611.1 ± 7.396-5.0 ± 6.1< .00185-5.7 ± 5.8< .001
ADHD-RS-IV subscale inattention13616.0 ± 5.497-6.8 ± 5.6< .00185-7.1 ± 5.9< .001
Subgroup analysis according to age group
ADHD-RS-IV total score
    Children8027.7 ± 12.958-11.7 ± 11.7< .00154-12.8 ± 11.3< .001
    Adolescents5626.2 ± 9.838-12.1 ± 9.3< .00131-12.5 ± 10.3< .001
ADHD-RS-IV subscale hyperactivity/impulsivity
    Children8011.8 ± 8.258-5.0 ± 6.8< .00154-6.0 ± 6.0< .001
    Adolescents5610.0 ± 5.638-5.1 ± 4.9< .00131-5.1 ± 5.4< .001
ADHD-RS-IV subscale inattention
    Children8015.9 ± 5.759-6.7 ± 5.6< .00154-6.9 ± 6.0< .001
    Adolescents5616.1 ± 5.138-7.0 ± 5.6< .00131-7.4 ± 5.9< .001

Baseline demographics and disease characteristics

Characteristic
Age (years)
  Mean ± SD11.2 ± 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 (%)
  White140 (100.0)
Sex, n (%)
  Male100 (71.4)
  Female40 (28.6)
Time since ADHD diagnosis (months), median (IQR) (N=138)22.0 (44.5)
ADHD diagnosis according to
  ICD-10138 (98.6)
  DSM-51 (0.7)
  DSM-IV1 (0.7)
ADHD diagnosis according to ICD-10, n (%)
  F90.0: disturbance of activity and attention97 (69.3)
  F90.1: hyperkinetic conduct disorder38 (27.1)
  F90.9: hyperkinetic disorder, unspecified3 (2.1)
ADHD diagnosis according to DSM-5, n (%)
  314.01: combined presentation1 (0.7)
ADHD diagnosis according to DSM-IV, n (%)
  314.01: predominantly hyperactive/impulsive type1 (0.7)
Additional conduct disorder, n (%)61 (43.6)
Concomitant diseases, n (%) (n≥3)
  All53 (37.9)
  Autism spectrum disorder9 (6.4)
  Disturbance in social behavior7 (5.0)
  Depression5 (3.6)
  Enuresis4 (2.9)
  Sleep disorder4 (2.9)
  Tic3 (2.1)

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

V1V2V3Δ V2 – V1Δ V3 – V1
NMean ± SDNMean ± SDNMean ± SDNMean ± SD p NMean ± SD p
Height [cm]140147.7 ± 18.996149.3 ± 17.186151.8 ± 16.6962.1 ± 2.1< .001865.7 ± 2.9< .001
Weight [kg]14042.7 ± 17.79741.6 ± 15.68743.4 ± 15.7971.2 ± 2.7< .001873.6 ± 3.7< .001
BMI z-score1400.20 ± 1.2096-0.12 ± 1.0886-0.10 ± 1.1196-0.18 ± 0.49< .00186-0.16 ± 0.630.018
Systolic blood pressure [mmHg]140112.1 ± 12.098113.5 ± 11.987114.3 ± 12.4982.4 ± 9.60.017873.8 ± 9.1< .001
Diastolic blood pressure [mmHg]14071.5 ± 8.69873.3 ± 8.48774.7 ± 8.5982.2 ± 8.80.016873.8 ± 9.0< .001
Heart rate [beats/min]14079.9 ± 13.79878.4 ± 12.08780.1 ± 13.1980.01 ± 9.5ns870.64 ± 13.0ns

Characteristics of treatment with previous MPH medications and DEX

Previous MPH treatment
Number of MPH therapies, n (%) (N=137)
    1118 (86.1)
    215 (11.0)
    33 (2.2)
    51 (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)
    116 (11.4)
    246 (32.9)
    324 (17.1)
    422 (15.7)
    54 (2.9)
    67 (5.0)
    101 (0.7)
    Optimal total daily dose not achieved18 (12.9)
    No titration performed2 (1.4)
Dose regimen, n (%) (N=129)
    Once daily76 (58.9)
    Twice daily50 (38.8)
    Three times daily2 (1.6)
    Four times daily1 (0.8)
DOI: https://doi.org/10.21307/sjcapp-2021-009 | Journal eISSN: 2245-8875
Journal RSS Feed
Language: English
Page range: 73 - 86
Published on: Apr 23, 2021
Published by: Psychiatric Research Unit
In partnership with: Paradigm Publishing Services
Publication frequency: 1 times per year
Keywords:
ADHD,
dexamphetamine,
children,
adolescents
Related subjects:
Medicine,
Basic medical science,
Basic medical science, other

© 2021 Henrik Uebel-von Sandersleben, Oliver Dangel, Roland Fischer, Michaela Ruhmann, Michael Huss, published by Psychiatric Research Unit
This work is licensed under the Creative Commons Attribution 4.0 License.

Previous articleVolume 9 (2021): Issue 1 (January 2021)Next article