Long-term safety and efficacy of guanfacine extended release in children and adolescents with attention-deficit/hyperactivity disorder.
OBJECTIVE
Short-term, controlled studies of extended-release guanfacine (GXR), a selective alpha(2A)-adrenoreceptor agonist, demonstrate efficacy in treating attention-deficit/hyperactivity disorder (ADHD) symptoms as monotherapy. This 2-year open-label study was conducted to further assess the long-term safety and efficacy of GXR.


METHODS
Study participants, aged 6-17 years with ADHD, had previously been exposed to GXR therapy alone or in combination with psychostimulants in one of two antecedent trials. In this study, doses were titrated to 1, 2, 3, or 4 mg/day of GXR alone or in combination with a psychostimulant. Safety and efficacy data collected at clinic visits over 24 months provided further evidence of the overall safety and efficacy of GXR for treating ADHD.


RESULTS
The majority of adverse events (AEs) were mild to moderate, and few patients discontinued the study because of an AE. Efficacy measures demonstrated significant improvement beginning in the first month and lasting through the end of the 24-month treatment period. Throughout the entire 2-year study, 202 subjects (77.1%) discontinued and 60 (22.9%) completed the study.


CONCLUSIONS
Overall, these data support that GXR monotherapy is generally safe and effective for treating ADHD.
Sallee
Floyd R
FR
Department of Psychiatry, University of Cincinnati, Cincinnati, Ohio 45219, USA. floyd.sallee@uc.edu
Lyne
Andrew
A
Wigal
Timothy
T
McGough
James J
JJ
D000293:Adolescent; D000316:Adrenergic alpha-Agonists / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001289:Attention Deficit Disorder with Hyperactivity / Q000188:drug therapy*; D000697:Central Nervous System Stimulants / Q000627:therapeutic use; D002648:Child; D003692:Delayed-Action Preparations; D004305:Dose-Response Relationship, Drug; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D016316:Guanfacine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D016896:Treatment Outcome
D000316:Adrenergic alpha-Agonists; D000697:Central Nervous System Stimulants; D003692:Delayed-Action Preparations; D016316:Guanfacine