Background: Extended-release guanfacine hydrochloride (GXR), a selective a2A-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.
EL TRABAJO DE CURACION DE UNA ENFERMEDAD CRONICA DEL NIÑO : RETOS, PROCESOS Y VULNERABILIDADES El alo-injerto de células madre hematopoiéticas es actualmente el único tratamiento potencialmente sanador de la drepanocitosis. A partir de este modelo espectacular de curación de una enfermedad crónica de niño, esta investigación retrospectiva, multicentrada y pluridisciplinaria tiene por objeto los procesos psíquicos de curación en sus dimensiones individuales, familiares, sociales y culturales. Comprende treinta y ocho por ciento de los pacientes injertados en Francia (N = 28) y sus familias. La curación somática no conlleva trastornos psiquiátricos o psicológicos específicos. Los elementos psicopatológicos encontrados y el sufrimiento psíquico expresado han permitido identificar y describir un trabajo psíquico de curación, cuya temporalidad es distinta de la de la curación somática. Este trabajo recoge tres retos principales : la nueva identidad, la trasmisión, el don. El tiempo necesario de este trabajo hace vulnerables al niño y a su familia. La curación efectiva no puede advenir sin que este trabajo psicológico se desarrolle en buenas condiciones para el niño y su familia.
Introduction:GXR, a selective α2A-adrenergic agonist, is a non-stimulant ADHD treatment approved in the USA for children and adolescents, and in Canada for children.Objectives:To evaluate long-term maintenance of efficacy of GXR in children and adolescents with ADHD who respond to an initial open-label, short-term trial.Aims:To determine if there is a higher rate of treatment failure for placebo vs GXR during the double-blind randomised-withdrawal phase (RWP) (NCT01081145).Methods:Patients (6–17 years) meeting DSM-IV-TR criteria for ADHD, baseline ADHD Rating Scale-IV (ADHD-RS-IV) ≥32 and Clinical Global Impressions-Severity (CGI-S) ratings ≥4 were enrolled. Following 7-week dose optimization and 6-week maintenance periods on open-label GXR (1–7 mg/day), eligible patients entered a 26-week, double-blind, RWP with GXR or placebo. The primary endpoint was rate of treatment failure (≥50% increase in ADHD-RS-IV total score and ≥2-point increase in CGI-S at two consecutive visits, compared to the RWP baseline). The key secondary endpoint was time-to-treatment failure. Safety assessments included treatment-emergent adverse events (TEAEs), electrocardiograms and vital signs.Results:Of 528 patients enrolled, 316 (60.0%) entered the RWP. At study end, 49.3% (GXR) and 64.9% (placebo) (95%CI; −26.6, −4.5, p<0.01) of patients had relapsed (Figure). Time-to-treatment failure was 56 days (placebo) versus 218 days (GXR), p=0.003. During the RWP, the most common GXR TEAEs (≥5% patients) were headache, somnolence and nasopharyngitis.Conclusions:GXR demonstrated long-term maintenance of efficacy versus placebo in children and adolescents with ADHD.
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