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; Oliver Dangel; Roland Fischer; Michaela Ruhmann; Michael Huss

doi:10.21307/sjcapp-2021-009

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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

Scandinavian Journal of Child and Adolescent Psychiatry and Psychology

Volume 9 (2021): Issue 1 (January 2021)

By: Henrik Uebel-von Sandersleben, Oliver Dangel, Roland Fischer, Michaela Ruhmann and Michael Huss

Open Access

|Apr 2021

Figures & Tables

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

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
Subgroup	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
Subgroup	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)

Articles in this issue

DOI: https://doi.org/10.21307/sjcapp-2021-009 | Journal eISSN: 2245-8875

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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 issue per year

Keywords:

ADHD,

Related subjects:

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.

Volume 9 (2021): Issue 1 (January 2021)

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

Figures & Tables

FIGURE 1.

FIGURE 2.

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

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

Baseline demographics and disease characteristics

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

Characteristics of treatment with previous MPH medications and DEX

Paradigm

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