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Eur Child Adolesc Psychiatry. 2018 Oct;27(10):1283-1294. doi: 10.1007/s00787-018-1113-4. Epub 2018 Feb 13.

Long-term safety and efficacy of guanfacine extended release in children and adolescents with ADHD.

Author information

1
Child and Adolescent Psychiatry, Johannes Gutenberg University Mainz, Mainz, Germany. m.huss@rfk.landeskrankenhaus.de.
2
Shire, Wayne, PA, USA.
3
ICON Clinical Research, North Wales, PA, USA.
4
Shire, Lexington, MA, USA.
5
Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
6
Department of Psychiatry (CIBERSAM), Hospital Universitari Vall d'Hebron and Universitat Autònoma de Barcelona, Barcelona, Spain.

Abstract

Data are reported from SPD503-318, a phase 3, open-label, safety study of guanfacine extended release (GXR) in European children and adolescents with attention-deficit/hyperactivity disorder (ADHD). Participants received dose-optimized GXR (1-7 mg/day) for up to 2 years. Of 215 enrolled participants, 214 were included in the safety population and 133 completed the study. Participants' mean age was 11.7 years and 73.8% were male. Overall, 177 participants (82.7%) experienced a treatment-emergent adverse event (TEAE). TEAEs reported in at least 10% of participants were somnolence (36.0%), headache (28.5%), fatigue (20.1%), and nasopharyngitis (11.7%). Serious TEAEs were reported in 4.7% of participants and TEAEs leading to discontinuation were reported in 3.3% of participants. There were no deaths. Mean z-scores for BMI were stable throughout the study. The incidence of sedative TEAEs (somnolence, sedation, and hypersomnia) peaked during week 3 and decreased thereafter. Small changes from baseline to the final assessment in mean supine pulse [- 5.5 bpm (standard deviation, 12.98)] and blood pressure [systolic, 0.6 mmHg (9.32); diastolic, 0.2 mmHg (9.17)] were reported. ADHD symptoms initially decreased and remained significantly lower than baseline at study endpoint. At the final assessment, the mean change in ADHD-RS-IV total score from baseline was - 19.8 (standard error of mean, 0.84; nominal p < 0.0001). In conclusion, GXR was well tolerated and more than 60% of participants completed the 2-year study.

KEYWORDS:

Attention-deficit/hyperactivity disorder; Child/adolescent; Clinical trial; Efficacy; Guanfacine extended release; Safety

PMID:
29442229
DOI:
10.1007/s00787-018-1113-4
[Indexed for MEDLINE]

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