Long-Term Treatment With Extended-Release Methylphenidate Treatment in Children Aged 4 to <6 Years.

Autor:	Childress AC; Dr. Childress is with the Center for Psychiatry and Behavioral Medicine, Inc., Las Vegas, Nevada., Foehl HC; Dr. Foehl is with Foehl Statistics & Analytics LLC, Glenmoore, Pennsylvania., Newcorn JH; Dr. Newcorn is with Icahn School of Medicine at Mount Sinai, New York., Faraone SV; Dr. Faraone is with SUNY Upstate Medical University, Syracuse, New York., Levinson B; Drs. Levinson and Adjei are currently retired. At the time of the study, Drs. Levinson and Adjei were with Rhodes Pharmaceuticals, Coventry, Rhode Island., Adjei AL; Drs. Levinson and Adjei are currently retired. At the time of the study, Drs. Levinson and Adjei were with Rhodes Pharmaceuticals, Coventry, Rhode Island. Electronic address: ladjei1949@gmail.com.
Jazyk:	angličtina
Zdroj:	Journal of the American Academy of Child and Adolescent Psychiatry [J Am Acad Child Adolesc Psychiatry] 2022 Jan; Vol. 61 (1), pp. 80-92. Date of Electronic Publication: 2021 Apr 20.
DOI:	10.1016/j.jaac.2021.03.019
Abstrakt:	Objective: To investigate long-term (12-month) safety and symptom control of extended-release methylphenidate (MPH-MLR) in children aged 4 to <6 years after treatment optimization. Method: A total of 90 children aged 4 to <6 years with attention-deficit/hyperactivity disorder (ADHD) were enrolled from 2 MPH-MLR studies. Treatment-emergent adverse events (TEAEs) and ADHD symptom control were assessed in the safety population (n = 89) and modeled with mixed model analyses. Results: Most TEAEs (89.9%) were rated by investigators as of mild or moderate severity. One serious AE was reported (unrelated to study drug). Ten children discontinued because of TEAEs. Two discontinued because of weight loss; no significant increase in the rate of underweight children from baseline to endpoint was observed. Overall, 18% lost weight and 18% reported decreased appetite. Weight and height z scores and obesity rates decreased significantly from baseline to endpoint. Insomnia was reported (9%); none of these children discontinued. Sleep quality did not change significantly. Hypertension was reported (6.7%); none of these children dropped out. Diastolic, but not systolic, blood pressure increased significantly during the follow-up. Control of ADHD symptoms was maintained throughout follow-up. Conclusion: These data contribute to the understanding of the long-term safety of an extended-release stimulant in children 4 to <6 years of age. The observed risk of a TEAE-related discontinuation was ∼11%. TEAEs were not dose related, and most were of mild to moderate severity. Symptom control was maintained through the year-long study. Clinical Trial Registration Information: A 12-Month Open Label Safety Study of Aptensio XR® in Children Ages 4-5 Years Diagnosed With ADHD (EF004); https://clinicaltrials.gov; NCT02677519. (Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.)
Databáze:	MEDLINE
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