A RANDOMIZED, CONTROLLED, EFFECTIVENESS TRIAL OF OROS- METHYLPHENIDATE COMPARED TO USUAL CARE WITH IMMEDIATE-RELEASE METHYLPHENIDATE IN ATTENTION DEFICIT- HYPERACTIVITY DISORDER

Main Article Content

Margaret Steele Steele
Margaret Weiss Weiss
James Swanson Swanson
Jenny Wang
Rosanna S Prinzo
Carin E Binder

Keywords

OROS® methylphenidate (OROS-MPH), immediate-release methylphenidate (IR-MPH), Attention-Deficit/Hyperactivity Disorder (ADHD), SNAP-IV parent-rating scale

Abstract

Background


The thrice daily dosing regimen of immediate release methylphenidate (IR-MPH) for Attention Deficit/Hyperactivity Disorder (ADHD) requires in-school dosing, leading to issues surrounding dispensing and storage of controlled substances by school personnel and concerns over children’s privacy and the embarrassment associated with taking medication in public at school. OROS-Methylphenidate (OROS-MPH) is a once-daily controlled-release formulation of methylphenidate (MPH) developed to overcome  some  of  the  limitations  associated  with  IR-MPH  and  first-generation  sustained-release formulations. Randomized, controlled trials (RCTs) that focus on treatment efficacy provide the best evidence for demonstrating whether an intervention works, but under ideal conditions one cannot discount the importance of efficacy study results. However, the most useful information to clinicians comes from an effectiveness study design.


 Objectives


To evaluate the effectiveness and tolerability of OROS-MPH versus usual care with IR-MPH in children aged 6 to 12 years with ADHD.


 Methods


This 8 week, multicentre, open-label study randomized 147 subjects to either once-daily OROS-MPH or usual care with IR-MPH. Subjects were titrated to a clinically effective dose of either study medication over 4 weeks and maintained on that dose for an additional 4 weeks. The SNAP-IV parent-rating scale was used to assess effectiveness.


 Results


OROS-MPH showed statistically significant superiority to IR-MPH in remission rate based on the 18 ADHD symptoms (p=0.0002, X2=13.8, df=1) and severity of ADHD and ODD symptoms (p=0.004, F=8.4, df=1,127), as well as on the following secondary assessments: IOWA Conners, Conners Parent Rating Scale (short version), Parent Stress Index, (short version); Visual Analogue Scale for social play; Clinical Global Impression-Severity, Clinical Global Impression-Improvement and Parent Satisfaction with treatment. OROS-MPH and IR-MPH were both well tolerated with a similar side effect profile.


 Conclusions


Once-daily OROS-MPH is significantly more effective than usual care with IR-MPH based on multiple outcome measures including remission rate.

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