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EPA-0627 - Safety Profile of Methylphenidate Hydrochloride-Modified Release (MPH-LA) in Adults and Children with Attention Deficit Hyperactivity Disorder
Published online by Cambridge University Press: 15 April 2020
Abstract
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Introduction and objectives:
The safety profile of MPH-LA in the paediatric population has been well studied. However, there are very limited studies reporting safety of MPH-LA in adults. We present the safety profile of MPH-LA in adults and from a pooled analysis in children.
Methods:
Data from 3 multiple-dose, double-blind, placebo-controlled studies of 7-12 weeks duration in children with ADHD; MPH-LA (10-80mg/d) (n=314) & placebo (n=318) (aged 6-12 yrs in 2 studies &13-17 yrs in one study) were pooled for this analysis. In addition, data from 722 adult patients, 18-60 yrs of age with ADHD receiving MPH-LA 40-80 mg/d (n=542) or placebo (n=180) from double-blind dose confirmation phase of 9-week duration from one study was included in the analysis.
Results:
Common adverse events (AEs) reported by both adult and paediatric ADHD patients were decreased appetite, headache, nasopharyngitis, nausea, and insomnia (Table). Incidence of serious AEs (SAEs) was low with MPH-LA in both adults (0.7%) and children (0.6%) compared with placebo group (1.1% in adults and 0.3% in children).
Conclusions:
Our findings show that safety profile of MPH-LA in adults is similar to that observed in the paediatric population.
Table
Adverse events (>5%) by preferred term in multiple dose, placebo-controlled studies In adult and paedlatrlc ADHD patients
| Adults | Children | |||
|---|---|---|---|---|
| Most common AEs | MPH-LA N=542, n (%) | Placebo N=1B0, n (%) | MPH-LA N=314, n (%) | Placebo N=31S, n (%) |
| Total number of patients with anyAE | 401 (74.0) | 108 (60.0) | 132 (42.0) | 112(35.2) |
| YDecreased appetite | 136(25.1) | 8 (4.4) | 30(9.6) | 5(1.6) |
| YHeadache | 111 (20.5) | 30 (16.7) | 37 (11.8) | 32 (10.1) |
| YDry mouth | 110(20.3) | 4(2.2) | 0 | 0 |
| YNausea | 58 (10.7) | 9(5.0) | 12 (3.8) | 4 (1.3) |
| YNasopharyngitis | 54 (10.0) | 17(9.4) | 13(4.1) | 15 (4.7) |
| YInsomnia | 44 (8.1) | 7(3.9) | 8 (2.5) | 4(1.3) |
| YHyperhidrosis | 43(7.9) | 5(2.8) | 0 | 0 |
| YPalpitations | 39(7.2) | 1 (0.6) | 0 | 0 |
| YFatigue | 38(7.0) | 11 (6.1) | 5(1.6) | 4(1.3) |
| YDizziness | 32 (5.9) | 5(2.8) | 5(16) | 1 (0.3) |
| YIrritability | 32(5.9) | 8 (4.4) | 4(1.3) | 1 (0.3) |
| YAnxiety | 29(5.4) | 1 (0.6) | 3(1.0) | 0 |
| YInitial insomnia | 28(5.2) | 2(1.1) | 5(1.6) | 5(1.6) |
Analysis data set: Safety population of double-blind dose confirmation phase of 9-week duration conducted in adult ADHD patients and pooled safety population from 3 paediatric studies.
- Type
- EPW09 - Psychopharmacology and Pharmacoeconomics 1
- Information
- Copyright
- Copyright © European Psychiatric Association 2014
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