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Guanfacine extended release in children and adolescents with attention-deficit/hyperactivity disorder: a placebo-controlled trial.

Abstract

OBJECTIVE

This study compared the efficacy of guanfacine extended release (GXR), a selective alpha(2A)-adrenoceptor agonist, with placebo in children and adolescents with attention-deficit/hyperactivity disorder (ADHD).

METHOD

This double-blind, 9-week, dose-ranging, parallel-design, multicenter trial randomized 6- to 17-year-olds with ADHD to once-daily oral GXR in 1-, 2-, 3-, and 4-mg doses or placebo. Primary outcome was change in total ADHD Rating Scale-IV score from baseline to endpoint. Secondary outcomes included changes in scores of hyperactive/impulsive and inattentive subscales; clinician and parent ratings; duration of clinical effect; and safety measures.

RESULTS

Statistically significant reductions in ADHD Rating Scale-IV scores were observed from baseline to endpoint at all doses of GXR, with effect sizes ranging from 0.43 to 0.62. In subjects receiving GXR, mean heart rate and systolic and diastolic blood pressure decreased as the dose of GXR increased and then returned toward baseline during the dose-maintenance and dose-tapering phases of the trial. Most frequent treatment-emergent adverse events (> or = 5%) were somnolence, headache, fatigue, sedation, dizziness, irritability, upper abdominal pain, and nausea. Somnolence, sedation, and fatigue adverse events emerged within the first 2 weeks of dosing and generally resolved by study end.

CONCLUSIONS

: Guanfacine extended-release was effective in reducing symptoms of ADHD. Adverse events were mild to moderate, did not interfere with improvements in attention, and rarely led to discontinuation.

Authors+Show Affiliations

Department of Psychiatry, University of Cincinnati, 231 Albert Sabin Way, ML 0559, Cincinnati, OH 45267, USA. floyd.sallee@uc.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

19106767

Citation

Sallee, Floyd R., et al. "Guanfacine Extended Release in Children and Adolescents With Attention-deficit/hyperactivity Disorder: a Placebo-controlled Trial." Journal of the American Academy of Child and Adolescent Psychiatry, vol. 48, no. 2, 2009, pp. 155-65.
Sallee FR, McGough J, Wigal T, et al. Guanfacine extended release in children and adolescents with attention-deficit/hyperactivity disorder: a placebo-controlled trial. J Am Acad Child Adolesc Psychiatry. 2009;48(2):155-65.
Sallee, F. R., McGough, J., Wigal, T., Donahue, J., Lyne, A., & Biederman, J. (2009). Guanfacine extended release in children and adolescents with attention-deficit/hyperactivity disorder: a placebo-controlled trial. Journal of the American Academy of Child and Adolescent Psychiatry, 48(2), pp. 155-65. doi:10.1097/CHI.0b013e318191769e.
Sallee FR, et al. Guanfacine Extended Release in Children and Adolescents With Attention-deficit/hyperactivity Disorder: a Placebo-controlled Trial. J Am Acad Child Adolesc Psychiatry. 2009;48(2):155-65. PubMed PMID: 19106767.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Guanfacine extended release in children and adolescents with attention-deficit/hyperactivity disorder: a placebo-controlled trial. AU - Sallee,Floyd R, AU - McGough,James, AU - Wigal,Tim, AU - Donahue,Jessica, AU - Lyne,Andrew, AU - Biederman,Joseph, AU - ,, PY - 2008/12/25/entrez PY - 2008/12/25/pubmed PY - 2010/8/11/medline SP - 155 EP - 65 JF - Journal of the American Academy of Child and Adolescent Psychiatry JO - J Am Acad Child Adolesc Psychiatry VL - 48 IS - 2 N2 - OBJECTIVE: This study compared the efficacy of guanfacine extended release (GXR), a selective alpha(2A)-adrenoceptor agonist, with placebo in children and adolescents with attention-deficit/hyperactivity disorder (ADHD). METHOD: This double-blind, 9-week, dose-ranging, parallel-design, multicenter trial randomized 6- to 17-year-olds with ADHD to once-daily oral GXR in 1-, 2-, 3-, and 4-mg doses or placebo. Primary outcome was change in total ADHD Rating Scale-IV score from baseline to endpoint. Secondary outcomes included changes in scores of hyperactive/impulsive and inattentive subscales; clinician and parent ratings; duration of clinical effect; and safety measures. RESULTS: Statistically significant reductions in ADHD Rating Scale-IV scores were observed from baseline to endpoint at all doses of GXR, with effect sizes ranging from 0.43 to 0.62. In subjects receiving GXR, mean heart rate and systolic and diastolic blood pressure decreased as the dose of GXR increased and then returned toward baseline during the dose-maintenance and dose-tapering phases of the trial. Most frequent treatment-emergent adverse events (> or = 5%) were somnolence, headache, fatigue, sedation, dizziness, irritability, upper abdominal pain, and nausea. Somnolence, sedation, and fatigue adverse events emerged within the first 2 weeks of dosing and generally resolved by study end. CONCLUSIONS: : Guanfacine extended-release was effective in reducing symptoms of ADHD. Adverse events were mild to moderate, did not interfere with improvements in attention, and rarely led to discontinuation. SN - 1527-5418 UR - https://www.unboundmedicine.com/medline/citation/19106767/Guanfacine_extended_release_in_children_and_adolescents_with_attention_deficit/hyperactivity_disorder:_a_placebo_controlled_trial_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0890-8567(09)60009-5 DB - PRIME DP - Unbound Medicine ER -