Effect of transitioning from extended-release methylphenidate onto osmotic, controlled-release methylphenidate in children/adolescents with ADHD: results of a 3-month non-interventional study

Abstract

Background:

To explore the clinical outcomes of children/adolescents with ADHD who transitioned from extended-release methylphenidate (ER MPH, Medikinet Retard^*) to osmotic release oral system (OROS) MPH (Concerta^†).

* Medikinet Retard is a registered trade name of Medice, Bad Iserlohn, Germany.

† Concerta is a registered trade name of Janssen–Cilag GmbH, Neuss, Germany.

Methods:

This prospective, non-interventional study included patients aged 6 to 18 years with a confirmed diagnosis of ADHD who experienced insufficient clinical response and/or poor tolerability on ER MPH. Patients transitioned onto OROS MPH and were followed for 12 weeks. Symptoms, functional outcome, health-related quality of life, safety and tolerability were assessed.

Results:

180 patients were included in the intention-to-treat analysis. The mean ER MPH dose before switching was 28.2 mg/day; mean OROS MPH starting dose was 38.1 mg/day, increasing to 41.2 mg/day at the final visit. Mean treatment duration was 79.49 ± 24.22 days (median 85; range 7–136). Several symptomatic and functional outcomes under OROS MPH treatment changed from baseline and included the Conners’ Parent Rating Scale (CPRS; −11.7 ± 11.3; p < 0.0001), C-GAS (12.3 ± 15.2; p < 0.0001) and ILC-LQ0-28 (parents’ rating 2.9 ± 4.3 and patients’ rating 2.8 ± 3.8; both p < 0.0001). Improvements in social interactions, playing with other children, doing household chores, or school homework, going to bed, and behavior towards visitors/at visits were noted (p < 0.0001). Approximately 40% of patients reported better sleep quality and appetite (p < 0.0001), and 72.8% expressed satisfaction with OROS MPH therapy compared to previous ER MPH. OROS MPH was well tolerated; the most common AEs after switching, with an incidence >2% and possibly related to therapy, were involuntary muscle contractions (tics; 8.9%), insomnia (7.2%) and anorexia (5.0%). No relevant changes in body weight or vital signs were observed. Three patients reported four serious AEs, but none were considered related to OROS MPH. Limitations included those associated with the uncontrolled, open-label design, possible inclusion bias and non-validation of the CPRS in a German population.

Conclusions:

Transitioning onto OROS MPH improved functionality, symptom control and decreased burden of disease in patients with ADHD who had insufficient response to, and/or poor tolerability of ER MPH. Similarly, care givers benefited from patients' treatment and reported significant reduction in their burden of disease and improvement of their quality of life upon the child's transition onto OROS MPH.

Key words::

• ADHD
• Children
• Extended-release methylphenidate
• Non-interventional study

Transparency

Declaration of funding

The study was funded by Janssen–Cilag GmbH, Neuss, Germany.

Declaration of financial/other relationships

K.R. is a consultant working for GEM, Meerbusch, Germany, who was hired by Janssen–Cilag to carry out the statistical analyses. L.S. and B.S are employees of Janssen-Cilag; at the time the study was conducted, M.G. was also an employee of Janssen-Cilag. M.G. is currently employed by Ipsen Pharma. A.L. has, in the past 3 years, been a speaker for Shire and Novartis. He is not an employee or a shareholder of any of these companies, and has no other financial or material support, including expert testimony, patents or royalties. F.M., A.A. and C.W. have disclosed that they have no significant relationships with or financial interests in any commercial companies related to this study or article.

Acknowledgements

The authors thank Andreas Schmidt MD PhD for the design of the study and medical oversight and Steve Clissold PhD and David Figgitt PhD, Content Ed Net, for providing editorial assistance in the preparation of this manuscript. This editorial support was funded by Janssen–Cilag GmbH, Germany. We also thank Detlef Wermelskirchen PhD, and Sascha Alexander Dichter MD for their critical review and comments on previous versions of this paper and all investigators, caregivers and patients who participated in this study.

Notes

* Medikinet Retard is a registered trade name of Medice, Bad Iserlohn, Germany.

† Concerta is a registered trade name of Janssen–Cilag GmbH, Neuss, Germany.

*Concerta is a registered trade name of Janssen–Cilag GmbH, Neuss, Germany.

†Medikinet Retard is a registered trade name of Medice, Bad Iserlohn, Germany.

‡Metadate is a registered trade name of UCB, Inc., Smyrna, GA, USA.