PMID- 19519256 OWN - NLM STAT- MEDLINE DCOM- 20090818 LR - 20131121 IS - 1557-8992 (Electronic) IS - 1044-5463 (Linking) VI - 19 IP - 3 DP - 2009 Jun TI - Long-term safety and efficacy of guanfacine extended release in children and adolescents with attention-deficit/hyperactivity disorder. PG - 215-26 LID - 10.1089/cap.2008.0080 [doi] AB - 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. FAU - Sallee, Floyd R AU - Sallee FR AD - Department of Psychiatry, University of Cincinnati, Cincinnati, Ohio 45219, USA. floyd.sallee@uc.edu FAU - Lyne, Andrew AU - Lyne A FAU - Wigal, Timothy AU - Wigal T FAU - McGough, James J AU - McGough JJ LA - eng PT - Controlled Clinical Trial PT - Journal Article PT - Multicenter Study PT - Research Support, Non-U.S. Gov't PL - United States TA - J Child Adolesc Psychopharmacol JT - Journal of child and adolescent psychopharmacology JID - 9105358 RN - 0 (Adrenergic alpha-Agonists) RN - 0 (Central Nervous System Stimulants) RN - 0 (Delayed-Action Preparations) RN - 30OMY4G3MK (Guanfacine) SB - IM MH - Adolescent MH - Adrenergic alpha-Agonists/administration & dosage/adverse effects/*therapeutic use MH - Attention Deficit Disorder with Hyperactivity/*drug therapy MH - Central Nervous System Stimulants/therapeutic use MH - Child MH - Delayed-Action Preparations MH - Dose-Response Relationship, Drug MH - Drug Therapy, Combination MH - Female MH - Follow-Up Studies MH - Guanfacine/administration & dosage/adverse effects/*therapeutic use MH - Humans MH - Male MH - Treatment Outcome EDAT- 2009/06/13 09:00 MHDA- 2009/08/19 09:00 CRDT- 2009/06/13 09:00 PHST- 2009/06/13 09:00 [entrez] PHST- 2009/06/13 09:00 [pubmed] PHST- 2009/08/19 09:00 [medline] AID - 10.1089/cap.2008.0080 [doi] PST - ppublish SO - J Child Adolesc Psychopharmacol. 2009 Jun;19(3):215-26. doi: 10.1089/cap.2008.0080.