Observational studyAdvances in therapy2026
Safety and Effectiveness of Lisdexamfetamine Dimesylate in Children and Adolescents with ADHD in Japan: An Interim Analysis of Post-Marketing Surveillance.
Observational study in Advances in therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Authors and funding
4 authors.
Funding
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Abstract
introductionThis 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.
methodsPatients (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.
resultsOverall, 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).
conclusionsNo 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 registrationUniversity Hospital Medical Information Network (UMIN) Clinical Trials Registry (identifier: UMIN000039018).
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