New European Study Showed OROS(R) Methylphenidate Tablets Significantly Improved Symptoms In Adults With ADHD

Main Category: ADHD
Also Included In: Psychology / Psychiatry
Article Date: 19 May 2008 - 1:00 PDT

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Adults with attention deficit hyperactivity disorder (ADHD) treated in an investigational study with OROS® methylphenidate tablets experienced significantly greater improvements in their ADHD symptoms compared to patients taking placebo, according to findings from a trial published in Biological Psychiatry. [i]

In the UK OROS methylphenidate tablets are approved as part of a comprehensive treatment programme for the treatment of children (over age 6) and adolescents with ADHD, but are currently not approved for the treatment of ADHD in adults. This study was an investigational study.

"While the pharmacological management of children and adolescents with ADHD is clearly established, relatively less is known about the treatment of adults diagnosed with this disorder," commented Dr Marios Adamou, Consultant Psychiatrist, Senior Lecturer, University of Kent. "The indicators show that many cases of ADHD extend into adulthood. The finding that OROS methylphenidate significantly improves ADHD symptoms in adults is encouraging - and represents an important addition to the growing body of knowledge in this evolving therapeutic area."

The Long-Acting Methylphenidate in Adult ADHD (LAMDA) trial was an investigational study carried out across 13 European countries and enrolled 402 adults with ADHD. Patients were randomised to receive one of three fixed doses of OROS methylphenidate tablets (18, 36 or 72 mg/day) or placebo for five weeks. Overall, 365 (91%) patients completed the five-week double blind study period.

During the study, treatment efficacy was measured using the Conners' Adult ADHD Rating Scale (CAARS) - an assessment tool for assessing ADHD symptoms in adults. Results showed that OROS methylphenidate achieved a significantly greater improvement in CAARS total ADHD symptom scores, compared to placebo for all doses at the end of five weeks (p< 0.015). The mean change from baseline to the study endpoint was -7.6 for the placebo group, -10.6 for methylphenidate 18mg/day (p = 0.015), -11.5 for the 36mg/day (p=0.013) and -13.7 for 72mg/day (p<0.001). At all tested doses, the largest improvement in symptoms with OROS methylphenidate occurred during the first week of treatment, with additional improvements noted throughout the five-week evaluation period.

The safety profile of OROS methylphenidate in the LAMDA study was consistent with its well-documented profile in children and adolescents. Adverse events in this study were reported by 75%, 76% and 82% of patients treated with 18 mg, 36 mg and 72 mg/day OROS methylphenidate tablets respectively - compared to 66% in the placebo group. The most commonly reported adverse events with OROS methylphenidate included decreased appetite, headache, insomnia, nausea and dry mouth. A total of 4.3% of patients on OROS methylphenidate tablets discontinued treatment due to adverse events.

OROS methylphenidate was associated with statistically significant increases in blood pressure at week one (systolic and diastolic) in the 72-mg group (p < 0.05) and week three (diastolic) in the 36-mg group (p <0.05). In all groups, change from baseline in blood pressure occurred at week one, with only slight further increases or decreases from week one through week five (systolic and diastolic increases varied from -0.6 to 4.0 mmHg and - 0.8 to 2.3 mmHg, respectively). Statistically significant increases were noted in pulse rate at all time points in those taking OROS methylphenidate (p <0.05), as well as at week three in the placebo group (p <0.05). By week 5, increases of 3.9 to 9.8 beats / minute were seen in patients taking OROS methylphenidate versus an increase of 2.7 beats / minute in the placebo group.

The authors of the study concluded that OROS methylphenidate was effective at doses of 18, 36 and 72mg/day in the treatment of ADHD in adults, with a safety profile consistent with its established use in children and adolescents.

Attention Deficit Hyperactivity Disorder (ADHD) is a common and treatable condition, which includes inattention, hyperactivity and impulsivity. It is one of the most common disorders of childhood. Although once considered to be a disorder only seen in children, ADHD is now considered to be a condition associated with a wide range of functional impairments in both children and adults.[ii] Overall, the prevalence of ADHD in adults is estimated to range between 3.4 and 4.4%, similar to that seen in children.[iii],[iv],[v]

What is ADHD?

Attention-deficit hyperactivity disorder (ADHD) is a medical condition classically affecting children and adolescents that is defined in the Diagnostic and Statistical Manual of Mental Disorders (DSM IV). It is now thought that ADHD may also affect adults, and this is an evolving area of research in psychiatry.

ADHD is characterised by three core symptoms: inattention, hyperactivity and impulsivity. Inattention can include an inability to focus and pay attention, a pattern of careless mistakes, difficulty listening or finishing tasks and easy distractibility. Hyperactivity may be manifested through fidgeting, talking excessively, and a tendency to run around at inappropriate times and interrupt others. Impulsivity may be exhibited as an inability to curb immediate reactions, often causing children to blurt out inappropriate comments or to run into the street without looking.

About OROS methylphenidate tablets

OROS methylphenidate tablets are marketed as Concerta® XL in the UK and are licensed for the treatment of ADHD in children and adolescents. Treatment must be initiated under the supervision of a specialist conversant with childhood and/or adolescent behavioural disorders.

Concerta® XL is not licensed for the treatment of ADHD in adults.

About Janssen-Cilag Ltd

Janssen-Cilag has a long track record in developing treatments for central nervous system disorders, pain management, oncology, fungal infections and gastrointestinal conditions. Products include Concerta® XL (ADHD), Durogesic® DTrans® (pain management), Eprex® (anaemia), Topamax® (epilepsy, migraine prevention), Risperdal® (schizophrenia, bipolar disorder), Risperdal® Consta® (schizophrenia) and Velcade® (progressive multiple myeloma).

More information can be found at http://www.janssen-cilag.co.uk

References

[i] Medori R et al. (2008): A Randomized, Placebo-Controlled Trial of Three Fixed Dosages of Prolonged-Release OROS Methylphenidate in Adults with Attention-Deficit/Hyperactivity Disorder. Biol Psychiatry. 2008; 63(10): 981-989.

[ii] Kessler RC et al. The prevalence and effects of adult attention deficit / hyperactivity disorder on work performance in a nationally representative sample of workers. Journal American Occupational Environmental Medicine 2005; 47(6): 565-572.

[iii] Kessler RC, Adler L, Barkley R, Biederman J, Conners CK, Demler O, et al. (2006): The prevalence and correlates of adult ADHD in the United States: results from the National Comorbidity Survey Replication. Am J Psychiatry. 163:716-723.

[iv] Kessler RC, Adler LA, Barkley R, Biederman J, Conners CK, Faraone SV, et al. (2005): Patterns and predictors of attention-deficit/hyperactivity disorder persistence into adulthood: results from the national comorbidity survey replication. Biol Psychiatry.57:1442-1451.

[v] Fayyad J, De Graaf R, Kessler R, Alonso J, Angermeyer M, Demyttenaere K, et al. (2007): Cross-national prevalence and correlates of adult attention-deficit hyperactivity disorder. Br J Psychiatry. 190:402-409.

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