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Abstract
ObjectiveThis study evaluated clinical outcomes in children and adolescents with attention-deficit/hyperactivity disorder (ADHD) treated with the α2-adrenoceptor agonist guanfacine extended-release (GXR) in routine Canadian clinical practice.MethodsThis retrospective chart review focused on patients with ADHD aged 6–17 years initiating treatment with GXR as monotherapy or adjunctive therapy. Patients were followed for up to 12 months after GXR initiation and, if they had received prior ADHD pharmacotherapy, for 12 months before GXR initiation. The primary outcome was change in ADHD symptoms and functionality based on physician assessments, classified as improvement, no change, or worsening relative to the time of GXR initiation. Treatment-emergent adverse events (TEAEs) were evaluated. Clinical outcomes were also analyzed post hoc according to whether GXR treatment was received as monotherapy or adjunctive therapy, and by select psychiatric comorbidities. Exploratory analyses were conducted in patients who had received prior ADHD pharmacotherapy to evaluate clinical outcomes after initiating GXR.ResultsImprovements in ADHD symptoms were reported for 232/330 (70.3%) patients. Functional improvements in school performance and home life were reported for 213/330 (64.5%) and 209/330 (63.3%) patients, respectively. The most frequent TEAEs (≥ 5%) were somnolence, headache, insomnia, presyncope, and decreased appetite. Improvements in ADHD symptoms were observed when GXR was received as either monotherapy (35/60 [58.3%]) or adjunctive therapy (197/270 [73.0%]). Improvements in ADHD symptoms and functionality were observed in the majority of patients with select psychiatric comorbidities. Among patients who had experienced worsening of symptoms with prior ADHD pharmacotherapy, 44/54 (81.5%) experienced symptom improvement, 33/44 (75.0%) who had previously experienced worsening of school performance improved, and 34/48 (70.8%) who had previously experienced worsening of home life improved.ConclusionIn Canadian routine clinical practice, most children and adolescents with ADHD treated with GXR experienced improvements in ADHD symptoms and in functionality both at school and at home.
Highlights
Attention-deficit/hyperactivity disorder (ADHD) is a neurodevelopmental disorder with childhood onset characterized by a pervasive pattern of age-inappropriate and excessive inattention and hyperactivity/impulsivity [1]
Study design and population This study was a retrospective medical chart review in children and adolescents with ADHD recruited from 10 sites by Canadian community- or hospital-based pediatricians, child psychiatrists, or family doctors specializing in ADHD
Exploratory analyses: assessments in symptoms and functionality in patients who had received prior ADHD pharmacotherapy In the subgroup who had received prior pharmacotherapy, a greater proportion of patients who had reported worsening ADHD symptoms on prior pharmacotherapy. This retrospective chart review deepens our understanding of guanfacine extended-release (GXR) use beyond the clinical trial setting, suggesting that children and adolescents with ADHD receiving GXR in real-world clinical practice experienced improvements in ADHD symptoms and functionality
Summary
Attention-deficit/hyperactivity disorder (ADHD) is a neurodevelopmental disorder with childhood onset characterized by a pervasive pattern of age-inappropriate and excessive inattention and hyperactivity/impulsivity [1]. The estimated worldwide prevalence of ADHD is ~ 5.3% [2]. From 2003 to 2011 ADHD incidence grew an average of 5% yearly, due to increased recognition and diagnosis [3]. Canadian ADHD prevalence rates are consistent with worldwide estimates; a recent retrospective review of medical records from Ontario found a prevalence rate of 5.4% (males, 7.9%; females, 2.7%) [4]. The socioeconomic burden of ADHD is considerable, impairing many aspects of children’s lives and their families, and negatively affecting academic performance and interpersonal relationships. In young people and adults, ADHD may be associated with higher risk of self-harm, traffic accidents, delinquency, and substance misuse [6]
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