Long-Term Treatment With Extended-Release Methylphenidate Treatment in Children Aged 4 to <6 Years
Ann C Childress1, Henry C Foehl2, Jeffrey H Newcorn3
1Dr. Childress is with the Center for Psychiatry and Behavioral Medicine, Inc., Las Vegas, Nevada.
Insights
Extended-release methylphenidate (MPH-MLR) demonstrated sustained ADHD symptom control in young children over 12 months. Most side effects were mild, with a low discontinuation rate, supporting its long-term safety in this age group.
Area of Science:
- Pediatric Psychiatry
- Pharmacology
- Neurodevelopmental Disorders
Background:
- Attention-deficit/hyperactivity disorder (ADHD) is a common neurodevelopmental disorder in children.
- Extended-release stimulant medications are frequently used for ADHD symptom management.
- Long-term safety and efficacy data in very young children (4 to <6 years) are crucial for optimizing treatment.
Purpose of the Study:
- To evaluate the 12-month safety and efficacy of extended-release methylphenidate (MPH-MLR) in children aged 4 to <6 years with ADHD.
- To assess treatment-emergent adverse events (TEAEs) and ADHD symptom control following treatment optimization.
Main Methods:
- A total of 90 children (aged 4 to <6 years) with ADHD were enrolled from two MPH-MLR studies.
- Safety and ADHD symptom control were assessed over a 12-month period.
- Mixed model analyses were used to evaluate TEAEs and symptom control.
Main Results:
- Most TEAEs (89.9%) were mild or moderate. Discontinuation due to TEAEs occurred in approximately 11% of participants.
- Weight and height z-scores and obesity rates decreased significantly; however, no significant increase in underweight children was observed.
- ADHD symptom control was maintained throughout the 12-month study period. Diastolic blood pressure increased significantly, but no significant changes in systolic blood pressure or sleep quality were noted.
Conclusions:
- Extended-release methylphenidate (MPH-MLR) is generally well-tolerated for long-term use in children aged 4 to <6 years with ADHD.
- The medication effectively maintained ADHD symptom control over 12 months.
- While some adverse events like decreased appetite and hypertension were observed, they were mostly mild to moderate and did not lead to significant long-term health issues or high discontinuation rates.
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.
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