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A randomized, double-blind, placebo-controlled study of guanfacine extended release in children and adolescents with attention-deficit/hyperactivity disorder.
Pediatrics 2008; 121(1):e73-84Ped

Abstract

OBJECTIVE

With this study we assessed the efficacy and safety of an extended-release formulation of guanfacine compared with placebo for the treatment of children and adolescents with attention-deficit/hyperactivity disorder.

METHODS

In this multicenter, double-blind, placebo-controlled, fixed-dosage escalation study, patients aged 6 to 17 years were randomly assigned to 1 of 3 treatment groups of guanfacine extended release (2, 3, or 4 mg/day) or placebo for 8 weeks. The primary outcome measurement was the Attention-Deficit/Hyperactivity Disorder Rating Scale IV total score. Secondary measurements included Clinical Global Impression of Improvement, Parent's Global Assessment, Conners' Parent Rating Scale-Revised: Short Form, and Conners' Teacher Rating Scale-Revised: Short Form.

RESULTS

A total of 345 patients were randomly assigned to placebo (n = 86) or guanfacine extended release 2 mg (n = 87), 3 mg (n = 86), or 4 mg (n = 86) treatment groups. Least-squares mean changes from baseline to the end point in Attention-Deficit/Hyperactivity Disorder Rating Scale IV total scores were significant in all groups of children taking guanfacine extended release: -16.18 in the 2-mg group, -16.43 in the 3-mg group, and -18.87 in the 4-mg group, compared with -8.48 in the placebo group. All groups of children taking guanfacine extended release showed significant improvement on hyperactivity/impulsivity and inattentiveness subscales of the Attention-Deficit/Hyperactivity Disorder Rating Scale IV, Clinical Global Impression of Improvement, Parent's Global Assessment, Conners' Parent Rating Scale-Revised: Short Form, and Conners' Teacher Rating Scale-Revised: Short Form assessments compared with placebo. The most commonly reported treatment-emergent adverse events were headache, somnolence, fatigue, upper abdominal pain, and sedation. Small to modest changes in blood pressure, pulse rate, and electrocardiogram parameters were observed but were not clinically meaningful.

CONCLUSIONS

Guanfacine extended release met the primary and secondary efficacy end points. It was well tolerated and effective compared with placebo.

Authors+Show Affiliations

Pediatric Psychopharmacology Department, Massachusetts General Hospital, Boston, Massachusetts 02114, USA. jbiederman@partners.orgNo affiliation info availableNo 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

18166547

Citation

Biederman, Joseph, et al. "A Randomized, Double-blind, Placebo-controlled Study of Guanfacine Extended Release in Children and Adolescents With Attention-deficit/hyperactivity Disorder." Pediatrics, vol. 121, no. 1, 2008, pp. e73-84.
Biederman J, Melmed RD, Patel A, et al. A randomized, double-blind, placebo-controlled study of guanfacine extended release in children and adolescents with attention-deficit/hyperactivity disorder. Pediatrics. 2008;121(1):e73-84.
Biederman, J., Melmed, R. D., Patel, A., McBurnett, K., Konow, J., Lyne, A., & Scherer, N. (2008). A randomized, double-blind, placebo-controlled study of guanfacine extended release in children and adolescents with attention-deficit/hyperactivity disorder. Pediatrics, 121(1), pp. e73-84. doi:10.1542/peds.2006-3695.
Biederman J, et al. A Randomized, Double-blind, Placebo-controlled Study of Guanfacine Extended Release in Children and Adolescents With Attention-deficit/hyperactivity Disorder. Pediatrics. 2008;121(1):e73-84. PubMed PMID: 18166547.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A randomized, double-blind, placebo-controlled study of guanfacine extended release in children and adolescents with attention-deficit/hyperactivity disorder. AU - Biederman,Joseph, AU - Melmed,Raun D, AU - Patel,Anil, AU - McBurnett,Keith, AU - Konow,Jennifer, AU - Lyne,Andrew, AU - Scherer,Noreen, AU - ,, PY - 2008/1/2/pubmed PY - 2008/2/6/medline PY - 2008/1/2/entrez SP - e73 EP - 84 JF - Pediatrics JO - Pediatrics VL - 121 IS - 1 N2 - OBJECTIVE: With this study we assessed the efficacy and safety of an extended-release formulation of guanfacine compared with placebo for the treatment of children and adolescents with attention-deficit/hyperactivity disorder. METHODS: In this multicenter, double-blind, placebo-controlled, fixed-dosage escalation study, patients aged 6 to 17 years were randomly assigned to 1 of 3 treatment groups of guanfacine extended release (2, 3, or 4 mg/day) or placebo for 8 weeks. The primary outcome measurement was the Attention-Deficit/Hyperactivity Disorder Rating Scale IV total score. Secondary measurements included Clinical Global Impression of Improvement, Parent's Global Assessment, Conners' Parent Rating Scale-Revised: Short Form, and Conners' Teacher Rating Scale-Revised: Short Form. RESULTS: A total of 345 patients were randomly assigned to placebo (n = 86) or guanfacine extended release 2 mg (n = 87), 3 mg (n = 86), or 4 mg (n = 86) treatment groups. Least-squares mean changes from baseline to the end point in Attention-Deficit/Hyperactivity Disorder Rating Scale IV total scores were significant in all groups of children taking guanfacine extended release: -16.18 in the 2-mg group, -16.43 in the 3-mg group, and -18.87 in the 4-mg group, compared with -8.48 in the placebo group. All groups of children taking guanfacine extended release showed significant improvement on hyperactivity/impulsivity and inattentiveness subscales of the Attention-Deficit/Hyperactivity Disorder Rating Scale IV, Clinical Global Impression of Improvement, Parent's Global Assessment, Conners' Parent Rating Scale-Revised: Short Form, and Conners' Teacher Rating Scale-Revised: Short Form assessments compared with placebo. The most commonly reported treatment-emergent adverse events were headache, somnolence, fatigue, upper abdominal pain, and sedation. Small to modest changes in blood pressure, pulse rate, and electrocardiogram parameters were observed but were not clinically meaningful. CONCLUSIONS: Guanfacine extended release met the primary and secondary efficacy end points. It was well tolerated and effective compared with placebo. SN - 1098-4275 UR - https://www.unboundmedicine.com/medline/citation/18166547/A_randomized_double_blind_placebo_controlled_study_of_guanfacine_extended_release_in_children_and_adolescents_with_attention_deficit/hyperactivity_disorder_ L2 - http://pediatrics.aappublications.org/cgi/pmidlookup?view=long&pmid=18166547 DB - PRIME DP - Unbound Medicine ER -