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A controlled trial of extended-release guanfacine and psychostimulants for attention-deficit/hyperactivity disorder.
J Am Acad Child Adolesc Psychiatry 2012; 51(1):74-85.e2JA

Abstract

OBJECTIVE

To examine efficacy, tolerability, and safety of guanfacine extended release (GXR; ≤4 mg/d) adjunctive to a long-acting psychostimulant for the treatment of attention-deficit/hyperactivity disorder (ADHD) in children and adolescents 6 to 17 years of age with suboptimal, but partial, response to psychostimulant alone.

METHOD

In this multicenter, 9-week, double-blind, placebo-controlled, dose-optimization study, subjects (N = 461) continued their stable dose of psychostimulant given in the morning and were randomized to receive GXR in the morning (GXR AM), GXR in the evening (GXR PM), or placebo. Efficacy measures included ADHD Rating Scale IV (ADHD-RS-IV) and Clinical Global Impressions of Severity of Illness (CGI-S) and Improvement (CGI-I) scales. Safety measures included adverse events (AEs), vital signs, electrocardiograms, and laboratory evaluations.

RESULTS

At endpoint, GXR treatment groups showed significantly greater improvement from baseline ADHD-RS-IV total scores compared with placebo plus psychostimulant (GXR AM, p = .002; GXR PM, p < .001). Significant benefits of GXR treatment versus placebo plus psychostimulant were observed on the CGI-S (GXR AM, p = .013; GXR PM, p < .001) and CGI-I (GXR AM, p = .024; GXR PM, p = .003). At endpoint, small mean decreases in pulse, systolic, and diastolic blood pressure were observed in GXR treatment groups versus placebo plus psychostimulant. No new safety signals emerged following administration of GXR with psychostimulants versus psychostimulants alone. Most AEs were mild to moderate in severity.

CONCLUSIONS

Morning or evening GXR administered adjunctively to a psychostimulant showed significantly greater improvement over placebo plus psychostimulant in ADHD symptoms and generated no new safety signals. Clinical trial registration information-Efficacy and Safety of SPD503 in Combination With Psychostimulants; http://www.clinicaltrials.gov; NCT00734578.

Authors+Show Affiliations

Massachusetts General Hospital, Boston, MA, USA. twilens@partners.orgNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

22176941

Citation

Wilens, Timothy E., et al. "A Controlled Trial of Extended-release Guanfacine and Psychostimulants for Attention-deficit/hyperactivity Disorder." Journal of the American Academy of Child and Adolescent Psychiatry, vol. 51, no. 1, 2012, pp. 74-85.e2.
Wilens TE, Bukstein O, Brams M, et al. A controlled trial of extended-release guanfacine and psychostimulants for attention-deficit/hyperactivity disorder. J Am Acad Child Adolesc Psychiatry. 2012;51(1):74-85.e2.
Wilens, T. E., Bukstein, O., Brams, M., Cutler, A. J., Childress, A., Rugino, T., ... Youcha, S. (2012). A controlled trial of extended-release guanfacine and psychostimulants for attention-deficit/hyperactivity disorder. Journal of the American Academy of Child and Adolescent Psychiatry, 51(1), pp. 74-85.e2. doi:10.1016/j.jaac.2011.10.012.
Wilens TE, et al. A Controlled Trial of Extended-release Guanfacine and Psychostimulants for Attention-deficit/hyperactivity Disorder. J Am Acad Child Adolesc Psychiatry. 2012;51(1):74-85.e2. PubMed PMID: 22176941.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A controlled trial of extended-release guanfacine and psychostimulants for attention-deficit/hyperactivity disorder. AU - Wilens,Timothy E, AU - Bukstein,Oscar, AU - Brams,Matthew, AU - Cutler,Andrew J, AU - Childress,Ann, AU - Rugino,Thomas, AU - Lyne,Andrew, AU - Grannis,Kara, AU - Youcha,Sharon, Y1 - 2011/11/25/ PY - 2011/05/12/received PY - 2011/08/25/revised PY - 2011/10/21/accepted PY - 2011/12/20/entrez PY - 2011/12/20/pubmed PY - 2012/4/27/medline SP - 74 EP - 85.e2 JF - Journal of the American Academy of Child and Adolescent Psychiatry JO - J Am Acad Child Adolesc Psychiatry VL - 51 IS - 1 N2 - OBJECTIVE: To examine efficacy, tolerability, and safety of guanfacine extended release (GXR; ≤4 mg/d) adjunctive to a long-acting psychostimulant for the treatment of attention-deficit/hyperactivity disorder (ADHD) in children and adolescents 6 to 17 years of age with suboptimal, but partial, response to psychostimulant alone. METHOD: In this multicenter, 9-week, double-blind, placebo-controlled, dose-optimization study, subjects (N = 461) continued their stable dose of psychostimulant given in the morning and were randomized to receive GXR in the morning (GXR AM), GXR in the evening (GXR PM), or placebo. Efficacy measures included ADHD Rating Scale IV (ADHD-RS-IV) and Clinical Global Impressions of Severity of Illness (CGI-S) and Improvement (CGI-I) scales. Safety measures included adverse events (AEs), vital signs, electrocardiograms, and laboratory evaluations. RESULTS: At endpoint, GXR treatment groups showed significantly greater improvement from baseline ADHD-RS-IV total scores compared with placebo plus psychostimulant (GXR AM, p = .002; GXR PM, p < .001). Significant benefits of GXR treatment versus placebo plus psychostimulant were observed on the CGI-S (GXR AM, p = .013; GXR PM, p < .001) and CGI-I (GXR AM, p = .024; GXR PM, p = .003). At endpoint, small mean decreases in pulse, systolic, and diastolic blood pressure were observed in GXR treatment groups versus placebo plus psychostimulant. No new safety signals emerged following administration of GXR with psychostimulants versus psychostimulants alone. Most AEs were mild to moderate in severity. CONCLUSIONS: Morning or evening GXR administered adjunctively to a psychostimulant showed significantly greater improvement over placebo plus psychostimulant in ADHD symptoms and generated no new safety signals. Clinical trial registration information-Efficacy and Safety of SPD503 in Combination With Psychostimulants; http://www.clinicaltrials.gov; NCT00734578. SN - 1527-5418 UR - https://www.unboundmedicine.com/medline/citation/22176941/A_controlled_trial_of_extended_release_guanfacine_and_psychostimulants_for_attention_deficit/hyperactivity_disorder_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0890-8567(11)00950-6 DB - PRIME DP - Unbound Medicine ER -