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Attention-deficit/hyperactivity disorder Under Treatment Outcomes Research (AUTOR): a European observational study in pediatric subjects.

Haynes V, Lopez-Romero P, Anand E - Atten Defic Hyperact Disord (2015)

Bottom Line: Among the secondary objectives, initial use of atomoxetine (vs. stimulants) was associated with a significant improvement on the CHIP-CE PRF total score, with an adjusted treatment difference of -6.0 (95 % CI -7.9, -4.1) at 24 months.Additionally, the odds of stability (CGI-ADHD-S ≤ 3 over the 2-year period) were significantly lower for subjects initially responding to stimulants compared with atomoxetine (OR 0.5; 95 % CI 0.3, 0.8).Response to initial treatment with atomoxetine was associated with improved QoL over 2 years.

View Article: PubMed Central - PubMed

Affiliation: Lilly Corporate Center, Eli Lilly and Company, Indianapolis, IN, 46285, USA. ginger.haynes@lilly.com.

ABSTRACT
The ADHD Under Treatment Observational Research (AUTOR) study was a European prospective, observational study that assessed factors associated with changes in ADHD severity, estimated change from baseline in quality of life (QoL), and characterized changes in ADHD symptoms over a 2-year period as a function of baseline treatment. The primary objective was to identify factors associated with worsening in ADHD severity during a 2-year follow-up period for subjects aged 6-17 years, who were receiving the same pharmacotherapy for 3-8 months before enrollment and had a Clinical Global Impression (CGI)-ADHD-Severity score of mild/lower and a CGI-ADHD-Improvement score of improved/very much improved. Multivariate logistic regression examined the association of factors with worsening in ADHD. Mixed-model repeated measures regression analyzed QoL in terms of change from baseline in CHIP-CE PRF scores. There were 704 subjects analyzed. Variables associated with worsening ADHD severity were parental occupation, poorer school outcomes, and use of psychoeducation; baseline treatment was not significant. Among the secondary objectives, initial use of atomoxetine (vs. stimulants) was associated with a significant improvement on the CHIP-CE PRF total score, with an adjusted treatment difference of -6.0 (95 % CI -7.9, -4.1) at 24 months. Additionally, the odds of stability (CGI-ADHD-S ≤ 3 over the 2-year period) were significantly lower for subjects initially responding to stimulants compared with atomoxetine (OR 0.5; 95 % CI 0.3, 0.8). ADHD symptom worsening was associated with initial use of psychoeducation, parental occupation, and poorer school outcomes. Response to initial treatment with atomoxetine was associated with improved QoL over 2 years.

No MeSH data available.


Related in: MedlinePlus

Kaplan–Meier plot for time to first change of therapy
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Related In: Results  -  Collection


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Fig2: Kaplan–Meier plot for time to first change of therapy

Mentions: Fewer subjects in the stimulant group at baseline changed therapy (7.9 vs. 11.4 %), discontinued treatment (13.2 vs. 14.9 %), or had a change of dose (17.9 vs. 23.3 %) versus subjects on atomoxetine at baseline. The log-rank test showed that there was no statistical difference between the treatments regarding time to any of these events. Time until 5 % of the population had an event is reported as the median time to event was not defined. As determined by the Kaplan–Meier survival curves, the estimated length in days and 95 % CI until 5 % of the population had an event for stimulant-treated versus atomoxetine-treated subjects for time to first change of therapy (Fig. 2) was 283.6 [153.8–565.3] days versus 269.6 [194.7–327.6] days, respectively. The estimated length in days and 95 % CI until 5 % of the population had an event for stimulant-treated versus atomoxetine-treated subjects for time to first treatment discontinuation (Fig. 3) was 194.7 [92.9–286.6] days versus 166.8 [113.9–244.7] days. The estimated length in days and 95 % CI until 5 % of the population had an event for stimulant-treated versus atomoxetine-treated subjects for time to first dose change (Fig. 4) was 89.9 [76.9–105.9] days versus 93.9 [81.9–126.8] days, respectively.Fig. 2


Attention-deficit/hyperactivity disorder Under Treatment Outcomes Research (AUTOR): a European observational study in pediatric subjects.

Haynes V, Lopez-Romero P, Anand E - Atten Defic Hyperact Disord (2015)

Kaplan–Meier plot for time to first change of therapy
© Copyright Policy - OpenAccess
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC4644194&req=5

Fig2: Kaplan–Meier plot for time to first change of therapy
Mentions: Fewer subjects in the stimulant group at baseline changed therapy (7.9 vs. 11.4 %), discontinued treatment (13.2 vs. 14.9 %), or had a change of dose (17.9 vs. 23.3 %) versus subjects on atomoxetine at baseline. The log-rank test showed that there was no statistical difference between the treatments regarding time to any of these events. Time until 5 % of the population had an event is reported as the median time to event was not defined. As determined by the Kaplan–Meier survival curves, the estimated length in days and 95 % CI until 5 % of the population had an event for stimulant-treated versus atomoxetine-treated subjects for time to first change of therapy (Fig. 2) was 283.6 [153.8–565.3] days versus 269.6 [194.7–327.6] days, respectively. The estimated length in days and 95 % CI until 5 % of the population had an event for stimulant-treated versus atomoxetine-treated subjects for time to first treatment discontinuation (Fig. 3) was 194.7 [92.9–286.6] days versus 166.8 [113.9–244.7] days. The estimated length in days and 95 % CI until 5 % of the population had an event for stimulant-treated versus atomoxetine-treated subjects for time to first dose change (Fig. 4) was 89.9 [76.9–105.9] days versus 93.9 [81.9–126.8] days, respectively.Fig. 2

Bottom Line: Among the secondary objectives, initial use of atomoxetine (vs. stimulants) was associated with a significant improvement on the CHIP-CE PRF total score, with an adjusted treatment difference of -6.0 (95 % CI -7.9, -4.1) at 24 months.Additionally, the odds of stability (CGI-ADHD-S ≤ 3 over the 2-year period) were significantly lower for subjects initially responding to stimulants compared with atomoxetine (OR 0.5; 95 % CI 0.3, 0.8).Response to initial treatment with atomoxetine was associated with improved QoL over 2 years.

View Article: PubMed Central - PubMed

Affiliation: Lilly Corporate Center, Eli Lilly and Company, Indianapolis, IN, 46285, USA. ginger.haynes@lilly.com.

ABSTRACT
The ADHD Under Treatment Observational Research (AUTOR) study was a European prospective, observational study that assessed factors associated with changes in ADHD severity, estimated change from baseline in quality of life (QoL), and characterized changes in ADHD symptoms over a 2-year period as a function of baseline treatment. The primary objective was to identify factors associated with worsening in ADHD severity during a 2-year follow-up period for subjects aged 6-17 years, who were receiving the same pharmacotherapy for 3-8 months before enrollment and had a Clinical Global Impression (CGI)-ADHD-Severity score of mild/lower and a CGI-ADHD-Improvement score of improved/very much improved. Multivariate logistic regression examined the association of factors with worsening in ADHD. Mixed-model repeated measures regression analyzed QoL in terms of change from baseline in CHIP-CE PRF scores. There were 704 subjects analyzed. Variables associated with worsening ADHD severity were parental occupation, poorer school outcomes, and use of psychoeducation; baseline treatment was not significant. Among the secondary objectives, initial use of atomoxetine (vs. stimulants) was associated with a significant improvement on the CHIP-CE PRF total score, with an adjusted treatment difference of -6.0 (95 % CI -7.9, -4.1) at 24 months. Additionally, the odds of stability (CGI-ADHD-S ≤ 3 over the 2-year period) were significantly lower for subjects initially responding to stimulants compared with atomoxetine (OR 0.5; 95 % CI 0.3, 0.8). ADHD symptom worsening was associated with initial use of psychoeducation, parental occupation, and poorer school outcomes. Response to initial treatment with atomoxetine was associated with improved QoL over 2 years.

No MeSH data available.


Related in: MedlinePlus