Efficacy and Safety of Lisdexamfetamine Dimesylate in Children with Attention-Deficit/Hyperactivity Disorder and Recent Methylphenidate Use
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INTRODUCTION: Lisdexamfetamine dimesylate (LDX) is a long-acting prodrug stimulant for the treatment of attention-deficit/hyperactivity disorder (ADHD). Post hoc subgroup analyses were performed from two studies in children with ADHD to compare the efficacy of LDX in participants who had received prior methylphenidate (MPH) treatment with that of the overall study populations. METHODS: Study 1 (7-week; open-label design) and study 2 (randomized, double-blind, placebo-controlled, crossover, laboratory school design) enrolled children aged 6-12 years with ADHD and baseline ADHD Rating Scale IV (ADHD-RS-IV) total score ≥28. Both studies excluded children whose prestudy ADHD treatment provided effective control of ADHD symptoms with an acceptable safety profile. Post hoc efficacy analyses were performed in children who had received MPH within 6 months of study enrollment. Efficacy measures included the following scales: ADHD-RS-IV, Clinical Global Impressions-Improvement (CGI-I), Expression and Emotion Scale for Children (EESC), Behavior Rating Inventory of Executive Function (BRIEF), Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP), and Permanent Product Measure of Performance (PERMP). RESULTS: In studies 1 and 2, 83/318 (26%) and 67/129 (52%) participants, respectively, had received MPH within 6 months and were not adequately controlled on current medication with acceptable tolerability; most of these participants had received long-acting MPH. In prior MPH participants, efficacy assessments demonstrated improvements from baseline (study 1) and versus placebo (study 2) that were comparable with those seen in the respective overall study population. Safety profiles were consistent with long-acting stimulant use. CONCLUSION: In two studies, children who had received prior MPH treatment improved during treatment with LDX and experienced similar improvements in their symptoms as the overall study populations. For children with ADHD who were previously treated with MPH, LDX may, therefore, be an efficacious treatment option.
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In Jain et al post hoc analysis of two large studies in children switched from methylphenidate to lisdexamfetamine, the subgroup with prior methylphenidate treatment showed significant improvement in ADHD-RS-IV scores comparable with overall results from the two open-label trials.
“The subgroup with prior methylphenidate treatment showed significant improvement in ADHD-RS-IV scores, which were comparable with overall results from the two open-label trials.”
From Update on optimal use of lisdexamfetamine in the treatment of ADHD (2013) · cites this paper as [32]
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- Authors
- Jain, R., Babcock, T., Burtea, T., Dirks, B., Adeyi, B., Scheckner, B., Lasser, R., Renna, J., & Duncan, D.
- Affiliations
- Shire (Canada) (CA)
- Interior Health (CA)
- Corresponding author
- Jain, Rakesh
- Venue
- Advances in Therapy
- Published
- 2013-05
- Volume
- 30
- Issue
- 5
- Pages
- 472-486
- ISSN
- 0741-238X (ISSN-L)
- 1865-8652
- PMC
- PMC3680667
- OpenAlex
- W2080506224
- Cited by
- 9
- References
- 40
- Citations by year
- 2022: 1 · 2020: 1 · 2019: 1 · 2018: 1 · 2015: 2 · 2014: 1 · 2013: 1 · 2012: 1
- FWCI
- 0.95
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- cc-by-nc
- Locations
- Advances in Therapy (publishedVersion, cc-by-nc)
- Europe PMC (PubMed Central) (publishedVersion)
- PubMed Central (publishedVersion, cc-by-nc)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Psychiatry and Mental health › Attention Deficit Hyperactivity Disorder
- Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Pharmaceutical studies and practices
- Health Sciences › Medicine › Pharmacology › Pharmacology and Obesity Treatment
- Keywords
- lisdexamfetamine dimesylate, attention deficit hyperactivity disorder, children, methylphenidate, long-acting stimulants, treatment efficacy, drug safety, ADHD symptoms, executive function
- MeSH terms
- Lisdexamfetamine Dimesylate, Central Nervous System Stimulants, Attention Deficit Disorder with Hyperactivity, Child, Dextroamphetamine, Double-Blind Method, Female, Humans, Male, Methylphenidate, Prodrugs, Treatment Outcome, Cross-Over Studies
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