Effects of extended-release guanfacine on ADHD symptoms and sedation-related adverse events in children with ADHD.
OBJECTIVE
Guanfacine extended release (GXR) is a selective alpha(2A)-adrenoceptor agonist that is shown to be an effective nonstimulant treatment for the symptoms of attention-deficit/hyperactivity disorder. This report documents the time course and predictors of symptom efficacy and sedation-related adverse events (AEs) that emerge during GXR treatment throughout 3 randomized, placebo-controlled, double-blind trials of the drug.


METHODS
Analysis of data from 3 GXR clinical trials.


RESULTS
Few variables related to the study participants or their treatment regimen affects the emergence or magnitude of sedation-related AEs. The best predictor of sedation is treatment duration, with the likelihood of sedation-related AEs decreasing with increasing time on medication. Sedation-related AEs are not predicted by the actual dose a participant receives, the magnitude of any dose changes, or the relationship between dose received and the magnitude of dose changes. Rates of discontinuation because of sedation-related side effects average 6.3% for GXR-treated participants and 0.5% for placebo-treated participants across the three trials.


CONCLUSIONS
These results suggest that acclimation to GXR may minimize the risk for, and magnitude of, sedation-related AEs. (J. of Att. Dis. 2010; 13(5) 532-538).
Faraone
Stephen V
SV
SUNY Upstate Medical University, Department of Psychiatry and Behavioral Sciences, 750 East AdamsStreet, Syracuse, NY, USA. faraones@upstate.edu
Glatt
Stephen J
SJ
D000293:Adolescent; D000316:Adrenergic alpha-Agonists / Q000008:administration & dosage / Q000009:adverse effects; D001289:Attention Deficit Disorder with Hyperactivity / Q000188:drug therapy*; D002648:Child; D003692:Delayed-Action Preparations; D004244:Dizziness / Q000139:chemically induced*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005221:Fatigue / Q000139:chemically induced*; D005260:Female; D016316:Guanfacine / Q000008:administration & dosage* / Q000009:adverse effects*; D006801:Humans; D008297:Male; D009325:Nausea / Q000139:chemically induced*; D018579:Patient Selection; D016032:Randomized Controlled Trials as Topic; D012044:Regression Analysis; D012720:Severity of Illness Index; D016896:Treatment Outcome
D000316:Adrenergic alpha-Agonists; D003692:Delayed-Action Preparations; D016316:Guanfacine