Extended-release guanfacine hydrochloride in 6–17-year olds with ADHD: a randomised-withdrawal maintenance of efficacy study / Jeffrey H. NEWCORN in Journal of Child Psychology and Psychiatry, 57-6 (June 2016)  

Public ISBD [article]  inJournal of Child Psychology and Psychiatry > 57-6 (June 2016) . - p.717-728 Titre : Extended-release guanfacine hydrochloride in 6–17-year olds with ADHD: a randomised-withdrawal maintenance of efficacy study Type de document : texte imprimé Auteurs : Jeffrey H. NEWCORN, Auteur ; Valerie HARPIN, Auteur ; Michael HUSS, Auteur ; Andrew LYNE, Auteur ; Vanja SIKIRICA, Auteur ; Mats JOHNSON, Auteur ; Josep Antoni RAMOS-QUIROGA, Auteur ; Judy VAN STRALEN, Auteur ; Benoit DUTRAY, Auteur ; Sasha SRECKOVIC, Auteur ; Ralph BLOOMFIELD, Auteur ; Brigitte ROBERTSON, Auteur Article en page(s) : p.717-728 Langues : Anglais (eng) Mots-clés : Long term  efficacy  randomised  withdrawal  attention-deficit/hyperactivity disorder  guanfacine Index. décimale : PER Périodiques Résumé : Background Extended-release guanfacine hydrochloride (GXR), a selective α2A-adrenergic agonist, is a nonstimulant medication for attention-deficit/hyperactivity disorder (ADHD). This phase 3, double-blind, placebo-controlled, randomised-withdrawal study evaluated the long-term maintenance of GXR efficacy in children/adolescents with ADHD. Methods Children/adolescents (6–17 years) with ADHD received open-label GXR (1–7 mg/day). After 13 weeks, responders were randomised to GXR or placebo in the 26-week, double-blind, randomised-withdrawal phase (RWP). The primary endpoint was the percentage of treatment failure (≥50% increase in ADHD Rating Scale version IV total score and ≥2-point increase in Clinical Global Impression-Severity compared with RWP baseline, at two consecutive visits). The key secondary endpoint was time to treatment failure (TTF). Trial registration ClinicalTrials.gov identifier NCT01081145; EudraCT 2009-018161-12. Results A total of 528 participants enrolled; 316 (59.8%) entered the RWP. Treatment failure occurred in 49.3% of the GXR and 64.9% of the placebo group (p = 0.006). TTF was significantly longer in GXR versus placebo (p = 0.003). GXR was well tolerated. Conclusions Guanfacine hydrochloride demonstrated long-term maintenance of efficacy compared with placebo in children/adolescents with ADHD. Implications of the placebo substitution design and findings with different ADHD medications are discussed. En ligne : http://dx.doi.org/10.1111/jcpp.12492 Permalink : https://www.cra-rhone-alpes.org/cid/opac_css/index.php?lvl=notice_display&id=289 [article] Extended-release guanfacine hydrochloride in 6–17-year olds with ADHD: a randomised-withdrawal maintenance of efficacy study [texte imprimé] / Jeffrey H. NEWCORN, Auteur ; Valerie HARPIN, Auteur ; Michael HUSS, Auteur ; Andrew LYNE, Auteur ; Vanja SIKIRICA, Auteur ; Mats JOHNSON, Auteur ; Josep Antoni RAMOS-QUIROGA, Auteur ; Judy VAN STRALEN, Auteur ; Benoit DUTRAY, Auteur ; Sasha SRECKOVIC, Auteur ; Ralph BLOOMFIELD, Auteur ; Brigitte ROBERTSON, Auteur . - p.717-728. Langues : Anglais (eng) in Journal of Child Psychology and Psychiatry > 57-6 (June 2016) . - p.717-728 Mots-clés : Long term  efficacy  randomised  withdrawal  attention-deficit/hyperactivity disorder  guanfacine Index. décimale : PER Périodiques Résumé : Background Extended-release guanfacine hydrochloride (GXR), a selective α2A-adrenergic agonist, is a nonstimulant medication for attention-deficit/hyperactivity disorder (ADHD). This phase 3, double-blind, placebo-controlled, randomised-withdrawal study evaluated the long-term maintenance of GXR efficacy in children/adolescents with ADHD. Methods Children/adolescents (6–17 years) with ADHD received open-label GXR (1–7 mg/day). After 13 weeks, responders were randomised to GXR or placebo in the 26-week, double-blind, randomised-withdrawal phase (RWP). The primary endpoint was the percentage of treatment failure (≥50% increase in ADHD Rating Scale version IV total score and ≥2-point increase in Clinical Global Impression-Severity compared with RWP baseline, at two consecutive visits). The key secondary endpoint was time to treatment failure (TTF). Trial registration ClinicalTrials.gov identifier NCT01081145; EudraCT 2009-018161-12. Results A total of 528 participants enrolled; 316 (59.8%) entered the RWP. Treatment failure occurred in 49.3% of the GXR and 64.9% of the placebo group (p = 0.006). TTF was significantly longer in GXR versus placebo (p = 0.003). GXR was well tolerated. Conclusions Guanfacine hydrochloride demonstrated long-term maintenance of efficacy compared with placebo in children/adolescents with ADHD. Implications of the placebo substitution design and findings with different ADHD medications are discussed. En ligne : http://dx.doi.org/10.1111/jcpp.12492 Permalink : https://www.cra-rhone-alpes.org/cid/opac_css/index.php?lvl=notice_display&id=289

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