Pharmacokinetics and pharmacodynamics of guanfacine extended release in adolescents aged 13-17 years with attention-deficit/hyperactivity disorder.
Clin Pharmacol Drug Dev
; 3(4): 252-61, 2014 07.
Article
in En
| MEDLINE
| ID: mdl-27128830
ABSTRACT
The safety and efficacy of guanfacine extended release (up to 4 mg/day) for attention-deficit/hyperactivity disorder (ADHD) in children and adolescents aged 6-17 years is well documented. Data suggest that weight-adjusted doses of guanfacine extended release >0.08 mg/kg but ≤0.12 mg/kg, if tolerated, may provide additional clinical benefits. For many adolescents, such dosing would exceed 4 mg/day, the highest approved dose. This open-label multicenter study evaluated the safety, tolerability, and steady-state pharmacokinetics of guanfacine extended release at escalated forced doses ≤9 mg/day in adolescents (N = 31) aged 13-17 years with ADHD. Following doses of approximately 0.12 mg/kg, the highest weight group (>70-90 kg) exhibited lower mean clearance at steady-state than the lowest weight group (≥30-50 kg). Consistent with its known antihypertensive effects, guanfacine extended release was associated with dose-dependent decreases in blood pressure (BP) and heart rate (HR). The physiologic response of increased BP upon standing was blunted in a dose-related manner while the physiologic response of increased HR upon standing was not substantively affected. The most common treatment-emergent adverse events were somnolence, dizziness, and sinus bradycardia. These results, and those from prior studies, support further examination of the efficacy and safety of higher weight-adjusted doses of guanfacine extended release for ADHD.
Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Attention Deficit Disorder with Hyperactivity
/
Guanfacine
/
Adolescent Behavior
/
Adrenergic alpha-2 Receptor Agonists
Type of study:
Clinical_trials
/
Diagnostic_studies
Limits:
Adolescent
/
Female
/
Humans
/
Male
Country/Region as subject:
America do norte
Language:
En
Journal:
Clin Pharmacol Drug Dev
Year:
2014
Type:
Article
Affiliation country:
Panama