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. 2021 Oct 4;15(1):55.
doi: 10.1186/s13034-021-00402-5.

A retrospective medical chart review of clinical outcomes in children and adolescents with attention-deficit/hyperactivity disorder treated with guanfacine extended-release in routine Canadian clinical practice

Judy van Stralen  1 , Simerpal K Gill  2 , Christopher J Reaume  3 , Kenneth Handelman  4
Affiliations

A retrospective medical chart review of clinical outcomes in children and adolescents with attention-deficit/hyperactivity disorder treated with guanfacine extended-release in routine Canadian clinical practice

Judy van Stralen et al. Child Adolesc Psychiatry Ment Health. .

Abstract

Objective: This 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.

Methods: This 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.

Results: Improvements 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.

Conclusion: In 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.

Keywords: ADHD; ADHD symptoms; Chart review; Guanfacine extended-release; Non-stimulant.

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Conflict of interest statement

JvS has received compensation for serving as a consultant and speaker for Janssen, Purdue Pharma, and Takeda Canada Inc. JvS has also received educational grants from Janssen, Purdue Pharma, and Takeda Canada Inc., and research grants from Emalex, Janssen, Nuvelution, Purdue Pharma, Takeda Canada Inc., Biohaven and Teva. JvS has also participated in advisory boards and speaker bureaus for Janssen, Purdue Pharma, and Takeda Canada Inc. JvS owns stocks in Johnson & Johnson. SKG is an employee of Takeda Canada Inc. SKG owns stock/stock options in Takeda. CJR was an employee of Shire Pharma Canada ULC (now Takeda Canada Inc.) at the time of the study. CJR is currently an employee of Medison Canada. KH has received research grants and speaking honoraria from Takeda Canada Inc., and has acted on advisory boards and speaker bureaus for Sunovion, Janssen, Purdue, and Takeda Canada Inc.

Figures

Fig. 1
Fig. 1
A ADHD symptoms and B functionality while receiving GXR: overall and by therapy type (monotherapy or adjunctive therapy). Symptoms and functionality assessed in the overall population was the primary analysis; assessment by therapy type was a post-hoc analysis. Best symptom response while on treatment with GXR was reported. Data for ADHD symptom assessment were derived from ADHD rating scales for 313 patients and from clinical notes for 17 patients. Data for ADHD functional assessment were derived from ADHD rating scales for 309 patients and from clinical notes for 21 patients. Adjunctive therapy was defined as patients receiving concomitant pharmacologic ADHD treatments. Percentages are based on the total number of enrolled patients. Due to missing values (≥ 6 months’ follow-up was required for inclusion in the study; patients may have discontinued between months 6 and 12), percentages in each category do not add up to 100%. ADHD attention-deficit/hyperactivity disorder, GXR guanfacine extended-release
Fig. 2
Fig. 2
Best ADHD symptom and functional response (post-hoc subgroup analyses) (n = 44). Post-hoc analyses examined best symptom response and best functional response while on treatment with GXR among patients who were initiated on GXR to reduce the use of atypical antipsychotics. Percentages were based on the total number of overall patients. Due to missing values (≥ 6 months’ follow-up was required for inclusion in the study; patients may have discontinued between months 6 and 12), percentages in each category do not add up to 100%. aBased on General Physician ADHD Symptom Assessment. bBased on General Physician Functional Assessment. ADHD attention-deficit/hyperactivity disorder, GXR guanfacine extended-release
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