Long-term safety and efficacy of guanfacine extended release in children and adolescents with ADHD.
In: European Child & Adolescent Psychiatry, Jg. 27 (2018-10-01), Heft 10, S. 1283-1294
Online
academicJournal
Zugriff:
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. [ABSTRACT FROM AUTHOR]
Copyright of European Child & Adolescent Psychiatry is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
Titel: |
Long-term safety and efficacy of guanfacine extended release in children and adolescents with ADHD.
|
---|---|
Autor/in / Beteiligte Person: | Huss, Michael ; Dirks, Bryan ; Gu, Joan ; Robertson, Brigitte ; Newcorn, Jeffrey H. ; Ramos-Quiroga, J. Antoni |
Link: | |
Zeitschrift: | European Child & Adolescent Psychiatry, Jg. 27 (2018-10-01), Heft 10, S. 1283-1294 |
Veröffentlichung: | 2018 |
Medientyp: | academicJournal |
ISSN: | 1018-8827 (print) |
DOI: | 10.1007/s00787-018-1113-4 |
Schlagwort: |
|
Sonstiges: |
|