PMID- 19395648 OWN - NLM STAT- MEDLINE DCOM- 20100525 LR - 20131121 IS - 1557-1246 (Electronic) IS - 1087-0547 (Linking) VI - 13 IP - 5 DP - 2010 Mar TI - Effects of extended-release guanfacine on ADHD symptoms and sedation-related adverse events in children with ADHD. PG - 532-8 LID - 10.1177/1087054709332472 [doi] AB - 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. METHOD: 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. CONCLUSION: 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). FAU - Faraone, Stephen V AU - Faraone SV AD - SUNY Upstate Medical University, Department of Psychiatry and Behavioral Sciences, 750 East AdamsStreet, Syracuse, NY, USA. faraones@upstate.edu FAU - Glatt, Stephen J AU - Glatt SJ LA - eng PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20090424 PL - United States TA - J Atten Disord JT - Journal of attention disorders JID - 9615686 RN - 0 (Adrenergic alpha-Agonists) RN - 0 (Delayed-Action Preparations) RN - 30OMY4G3MK (Guanfacine) SB - IM MH - Adolescent MH - Adrenergic alpha-Agonists/administration & dosage/adverse effects MH - Attention Deficit Disorder with Hyperactivity/*drug therapy MH - Child MH - Delayed-Action Preparations MH - Dizziness/*chemically induced MH - Dose-Response Relationship, Drug MH - Double-Blind Method MH - Drug Administration Schedule MH - Fatigue/*chemically induced MH - Female MH - Guanfacine/*administration & dosage/*adverse effects MH - Humans MH - Male MH - Nausea/*chemically induced MH - Patient Selection MH - Randomized Controlled Trials as Topic MH - Regression Analysis MH - Severity of Illness Index MH - Treatment Outcome EDAT- 2009/04/28 09:00 MHDA- 2010/05/26 06:00 CRDT- 2009/04/28 09:00 PHST- 2009/04/28 09:00 [entrez] PHST- 2009/04/28 09:00 [pubmed] PHST- 2010/05/26 06:00 [medline] AID - 1087054709332472 [pii] AID - 10.1177/1087054709332472 [doi] PST - ppublish SO - J Atten Disord. 2010 Mar;13(5):532-8. doi: 10.1177/1087054709332472. Epub 2009 Apr 24.