Volume 49, Issue 1 , Pages 24-32, January 2010
Effects of Lisdexamfetamine Dimesylate Treatment for ADHD on Growth
Objective
To complete an exploratory uncontrolled study of the effects of lisdexamfetamine dimesylate (LDX) on growth of children treated for attention-deficit/hyperactivity disorder (ADHD).
Method
Height, weight, and body mass index (BMI) from 281 children ages 6 to 13 years from longitudinal assessments up to 15 months were compared to norms from the Centers for Disease Control.
Results
At study entry, children were taller and heavier than average. Growth delays were largest for weight and BMI, and there was a 13 percentile point decrease in height. Children continued to grow in terms of height while treated with LDX; we found no increase in raw weight or BMI during the study period. LDX treatment was significantly associated with diminished gains in height, weight, and BMI compared to levels that would be expected based on age-appropriate standards from the Centers for Disease Control. Growth delays were greatest for the heaviest and tallest children, for those who had not previously received stimulant therapy, and for those with a greater cumulative exposure to LDX. More work is needed to determine effects on ultimate adult height.
Conclusions
Consistent with prior studies of stimulants, treatment with LDX leads to statistically significant reductions in expected height, weight, and BMI. Growth of patients with ADHD treated with LDX should be closely monitored and corrective action taken should growth delays be observed.
Clinical trial registry information—Phase 3 Randomized Double-Blind Placebo-Controlled Study of NRP104 in Children Aged 6-12 With ADHD, URL: http://www.clinicaltrials.gov, unique identifier: NCT00556296; NRP104, Adderall XR or Placebo in Children Aged 6-12 Years with ADHD; URL: http://www.clinicaltrials.gov, unique identifier: NCT00557011.
Key Words: attention-deficit/hyperactivity disorder, growth, lisdexamfetamine dimesylate, amphetamine, stimulants
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This article was reviewed under and accepted by Ad Hoc Editor Kenneth Towbin, M.D.
This work was supported by Shire Development, Inc.
This article includes information from NRP104.302 Interim Analysis of a Long-Term, Open-Label, Single-Arm Study of Lisdexamfetamine (LDX), an Amphetamine Prodrug, in Children With ADHD: This study was started on November 21, 2004, and completed on March 23, 2006, and at the time of the study, industry standards and Shire standard operating procedures did not require posting of open-label studies.
Disclosure: In the past year, Dr. Faraone has served as a consultant and on advisory boards for Eli Lilly & Company, Ortho-McNeil, and Shire, and has received research support from Eli Lilly & Company, Pfizer, Shire, and the National Institutes of Health. In previous years, Dr. Faraone has served as a consultant, on advisory boards, or on the speakers' bureau for Shire, McNeil, Janssen, Novartis, Pfizer, and Eli Lilly & Company. In previous years, he has received research support from Eli Lilly, Shire, Pfizer, and the National Institutes of Health. Dr. Glatt has received research support from the National Institutes of Health. He has received research support from, served as a consultant for, or served on the speakers' bureau for Shire Laboratories, and the National Institutes of Health. Dr. Spencer receives research support from Shire Laboratories, Cephalon, Eli Lilly & Company, GlaxoSmithKline, Janssen, McNeil Pharmaceutical, Novartis Pharmaceuticals, Pfizer, and the National Institute of Mental Health. He has served on the speakers' bureaus for Shire Laboratories, Eli Lilly & Company, GlaxoSmithKline, Janssen, McNeil Pharmaceutical, and Novartis Pharmaceuticals. He has served on the advisory boards for Shire Laboratories, Cephalon, Eli Lilly & Company, GlaxoSmithKline, Janssen, McNeil Pharmaceutical, Novartis Pharmaceuticals, and Pfizer. Dr. Kollins has received research support from Addrenex Pharmaceuticals, Comentis, Shire Pharmaceuticals, the National Institute on Drug Abuse, the National Institute of Mental Health, the National Institute of Neurological Disorders and Stroke, the National Institute of Environmental Health Services, and the Environmental Protection Agency. Dr. Kollins has served as a consultant for Addrenex Pharmaceuticals, Comentis, Shire Pharmaceuticals, and the National Institute on Drug Abuse.
PII: S0890-8567(09)00009-4
doi:10.1016/j.jaac.2009.10.003
© 2010 Published by Elsevier Inc.
Volume 49, Issue 1 , Pages 24-32, January 2010
