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Introduction <p>This post-marketing surveillance study investigated safety and effectiveness of lisdexamfetamine dimesylate (LDX) in paediatric attention-deficit/hyperactivity disorder (ADHD) in routine clinical practice in Japan.</p> Methods <p>Patients (aged 6 to&#xa0;&lt;&#xa0;18&#xa0;years) were enrolled in this prospective, observational study from January 2020 to December 2023 and received an LDX dose determined by the investigator. Safety (including dependence and abuse) and effectiveness were evaluated for 2&#xa0;years after treatment initiation. Dependence and abuse were also assessed for 3 additional years in those still receiving LDX. The data cut-off date for this interim analysis was 21 January 2024.</p> Results <p>Overall, 1819 patients were enrolled across 188 sites and case report forms were collected for 1012 patients. Of these, 1006 and 916 patients were included in the safety and effectiveness analyses, respectively. The adverse drug reactions (ADRs) of decreased appetite (19.3%), insomnia (3.7%), nausea (3.4%), weight decrease (2.8%), headache (2.6%), aggression (2.4%), initial insomnia (1.8%), irritability (1.8%), tic (1.6%), and agitation (1.3%), were reported in&#xa0;≥&#xa0;1% of patients. Eight serious ADRs occurred in five patients: decreased appetite (<i>n</i>&#xa0;=&#xa0;3), and anger, hyperthyroidism, palpitations, poor weight gain, and suicide attempt (<i>n</i>&#xa0;=&#xa0;1 each). For ADRs defined as important identified risks or important potential risks of LDX, one non-serious syncope event was observed. No dependence- or abuse-related events of LDX were reported. An increasing proportion of patients had improvements in the Clinical Global Impression–Improvement scale during the first year of observation, and improvements were maintained through the second year. Improvements from baseline in ADHD-Rating Scale-IV total and subscale scores increased over the 2-year observation period; significant improvements in the total score were observed at all time points (<i>p</i>&#xa0;&lt;&#xa0;0.0001).</p> Conclusions <p>No ADRs requiring new safety measures were observed. The effectiveness of LDX was confirmed in real-world practice. This study is ongoing, and the final results will be reported upon completion.</p> Trial Registration <p>University Hospital Medical Information Network (UMIN) Clinical Trials Registry (identifier: UMIN000039018).</p>

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Safety and Effectiveness of Lisdexamfetamine Dimesylate in Children and Adolescents with ADHD in Japan: An Interim Analysis of Post-Marketing Surveillance

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年3月12日

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  • Takashi Okada,
  • Hiroyuki Ida,
  • Kouji Yamashita,
  • Kazuhiko Saito

摘要

Introduction

This post-marketing surveillance study investigated safety and effectiveness of lisdexamfetamine dimesylate (LDX) in paediatric attention-deficit/hyperactivity disorder (ADHD) in routine clinical practice in Japan.

Methods

Patients (aged 6 to < 18 years) were enrolled in this prospective, observational study from January 2020 to December 2023 and received an LDX dose determined by the investigator. Safety (including dependence and abuse) and effectiveness were evaluated for 2 years after treatment initiation. Dependence and abuse were also assessed for 3 additional years in those still receiving LDX. The data cut-off date for this interim analysis was 21 January 2024.

Results

Overall, 1819 patients were enrolled across 188 sites and case report forms were collected for 1012 patients. Of these, 1006 and 916 patients were included in the safety and effectiveness analyses, respectively. The adverse drug reactions (ADRs) of decreased appetite (19.3%), insomnia (3.7%), nausea (3.4%), weight decrease (2.8%), headache (2.6%), aggression (2.4%), initial insomnia (1.8%), irritability (1.8%), tic (1.6%), and agitation (1.3%), were reported in ≥ 1% of patients. Eight serious ADRs occurred in five patients: decreased appetite (n = 3), and anger, hyperthyroidism, palpitations, poor weight gain, and suicide attempt (n = 1 each). For ADRs defined as important identified risks or important potential risks of LDX, one non-serious syncope event was observed. No dependence- or abuse-related events of LDX were reported. An increasing proportion of patients had improvements in the Clinical Global Impression–Improvement scale during the first year of observation, and improvements were maintained through the second year. Improvements from baseline in ADHD-Rating Scale-IV total and subscale scores increased over the 2-year observation period; significant improvements in the total score were observed at all time points (p < 0.0001).

Conclusions

No ADRs requiring new safety measures were observed. The effectiveness of LDX was confirmed in real-world practice. This study is ongoing, and the final results will be reported upon completion.

Trial Registration

University Hospital Medical Information Network (UMIN) Clinical Trials Registry (identifier: UMIN000039018).