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Long-acting medications for the hyperkinetic disorders

A systematic review and European treatment guideline

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Abstract

A systematic review of published and unpublished data on the use of long-acting medications in ADHD and hyperkinetic disorder is reported, giving effect sizes and numbers-to-treat for extended-release stimulant preparations and atomoxetine (ATX). A panel of experts from several European countries used the review to make recommendations about the use of these drugs in practice, and conclusions are reported: (1) Long-acting preparations should be available and used; (2) They should not replace short-acting drugs (which will be the initial treatment for many children for reasons of cost and flexibility of dosing). Individual clinical choice is needed. (3) Both ATX and extended-release preparations of stimulants should be available. The choice will depend upon the circumstances, and detailed recommendations are made.

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Notes

  1. The spelling of dexamfetamine reflects the changes made in ‘Recommended International Non-proprietary Names’ (rINN) and ‘New British Approved Names’ (BAN) and follow European Directive 92/27/EEC. “Amphetamine” has not yet followed the convention. We are therefore following this inconsistent rule of spelling to help people using electronic retrieval. Trade rather than generic names of drugs have been used to distinguish the different preparations conveniently.

  2. Useful websites with fuller information about these interactions can be found at http://medicine.iupui.edu/flockhart/table.htm or at http://www.medscape.com/druginfo/druginterchecker?src=ads

  3. However, the IR MPH overcoat of the capsule could still be misused.

  4. Since these are determined by price, and price will vary from time to time and place to place, the prescriber is advised to check these generalisations against current circumstances. When considering the total medication costs there is more than just the cost of one pill to consider. Many patients taking one medication require longer coverage, top-up doses and medication for comorbidities or side effects. One should not choose a long-acting medication purely based on price.

  5. It has to be mentioned that clinician ratings were based on different sources of information. The Medikinet retard and Equasym XL studies used direct observations (lab-school ratings). In the Strattera trials, clinical investigators were specifically instructed not to use any other information as the basis for the rating except parent interviews (most Strattera studies), respectively teacher reports (one Strattera study; 75. Weiss M, Tannock R, Kratochvil C, Dunn D, Velez-Borras J, Thomason C, Tamura R, Kelsey D, Stevens L, Allen AJ (2005) A randomised, placebo-controlled study of once-daily ATX in the school setting in children with ADHD. J Am Acad Child Adolesc Psychiatry 44:647–655).

  6. The appearance of placebo and Concerta XL was different, i.e. it was not a blinded study.

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Acknowledgements

The authors’ meeting was funded by equal contributions from several companies. The authors’ expenses for travel were paid but they received no fees. Some had potential competing interests, and these are detailed separately (appendix 2).

Author information

Authors and Affiliations

  1. Dept. of Child & Adolescent Psychiatry/Psychotherapy, University of Goettingen, Von-Siebold-Str. 5, 37075, Goettingen, Germany

    Tobias Banaschewski & Aribert Rothenberger

  2. Dept. of Psychiatry, University of Dundee, Dundee, SCO, UK

    David Coghill

  3. Dept. of Psychological Medicine, Hospital for Children, Great Ormond Street, London, UK

    Paramala Santosh

  4. Institute of Psychiatry, Maudsley Hospital, London, UK

    Paramala Santosh

  5. Child Neuropsychiatry, Dept. Neuroscience, University of Cagliari, Cagliari, Italy

    Alessandro Zuddas

  6. MRC Social Genetic & Developmental Research Centre, Institute of Psychiatry, Kings College London, London, UK

    Philip Asherson

  7. Dept. of Psychiatry, Academic Centre for Child & Adolescent Psychiatry, UMC St Radboud, Nijmegen, The Netherlands

    Jan Buitelaar

  8. Dept. Child & Adolescent Psychiatry, U. Z. Gasthuisberg, Leuven, Belgium

    Marina Danckaerts

  9. Psychiatry and Psychotherapy of Childhood & Adolescence, University of Cologne, Köln, Germany

    Manfred Döpfner

  10. Medical Genetics Research Program and Dept. of Psychiatry and Behavioral Sciences, SUNY Upstate Medical University, Syracuse, NY, USA

    Stephen V. Faraone

  11. Dept. of Clinical Neuropsychology, Faculty of Psychology & Education, Vrije Universitat, Amsterdam, The Netherlands

    Joseph Sergeant

  12. Dept. of Child & Adolescent Psychiatry, University of Zurich, Zürich, Switzerland

    Hans-Christoph Steinhausen

  13. Dept. of Psychology, University of Southampton, Southampton, UK

    Edmund J.S. Sonuga-Barke

  14. Dept. of Child & Adolescent Psychiatry, Institute of Psychiatry, Kings College London, London, UK

    Eric Taylor

Authors
  1. Tobias Banaschewski
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  2. David Coghill
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  6. Jan Buitelaar
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  7. Marina Danckaerts
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  8. Manfred Döpfner
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  9. Stephen V. Faraone
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  10. Aribert Rothenberger
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  11. Joseph Sergeant
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  12. Hans-Christoph Steinhausen
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  13. Edmund J.S. Sonuga-Barke
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  14. Eric Taylor
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Corresponding author

Correspondence to Tobias Banaschewski.

Appendices

Appendix 1

Excerpts from: “SIGN 50: A guideline developers’ handbook Section 6: Forming guideline recommendations” [55]

These excerpts are included to assist the reader understand the grading system used in this guideline. They are not intended as a substitute for the full SIGN guidance and anyone wishing to explore this area further should consult the full guidance [55]:

“Guideline recommendations are graded to differentiate between those based on strong evidence and those based on weak evidence. This judgment is made on the basis of an (objective) assessment of the design and quality of each study and a (perhaps more subjective) judgment on the consistency, clinical relevance and external validity of the whole body of evidence. The aim is to produce a recommendation that is evidence-based, but which is relevant to the way in which health care is delivered and is therefore implementable.

It is important to emphasise that the grading does not relate to the importance of the recommendation, but to the strength of the supporting evidence and, in particular, to the predictive power of the study designs from which that data was obtained. Thus, the grading assigned to a recommendation indicates to users the likelihood that, if that recommendation is implemented, the predicted outcome will be achieved.” SIGN grading system

Levels of evidence

1++

High quality meta analyses, systematic reviews of RCTs, or RCTs with a very low risk of bias

1+

Well conducted meta analyses, systematic reviews of RCTs, or RCTs with a low risk of bias

1−

Meta analyses, systematic reviews of RCTs, or RCTs with a high risk of bias

2++

High quality systematic reviews of case-control or cohort studies, High quality case–control or cohort studies with a very low risk of confounding, bias, or chance and a high probability that the relationship is causal

2+

Well conducted case–control or cohort studies with a low risk of confounding, bias, or chance and a moderate probability that the relationship is causal

2−

Case–control or cohort studies with a high risk of confounding, bias, or chance and a significant risk that the relationship is not causal

3

Non-analytic studies, e.g. case reports, case series

4

Expert opinion

Grades of recommendation

A

At least one meta-analysis, systematic review, or RCT rated as 1++, and directly applicable to the target population; or A systematic review of RCTs or a body of evidence consisting principally of studies rated as 1+, directly applicable to the target population, and demonstrating overall consistency of results

B

A body of evidence including studies rated as 2++, directly applicable to the target population, and demonstrating overall consistency of results; or Extrapolated evidence from studies rated as 1++ or 1+

C

A body of evidence including studies rated as 2+, directly applicable to the target population and demonstrating overall consistency of results; or Extrapolated evidence from studies rated as 2++

D

Evidence level 3 or 4; or Extrapolated evidence from studies rated as 2+

Good practice points

✓ Recommended best practice based on the clinical experience of the guideline development group

On occasion, guideline development groups find that there is an important practical point that they wish to emphasise but for which there is not, nor is their likely to be, any research evidence. This will typically be where some aspect of treatment is regarded as such sound clinical practice that nobody is likely to question it. These are marked in the guideline as Good Practice Points, and are indicated . It must be emphasised that these are not an alternative to evidence-based recommendations, and should only be used where there is no alternative means of highlighting the issue.

Appendix 2

Potential conflicts of interest

 

UCB

Lilly

Janssen/McNeil

Medice

Shire

Cephalon

Novartis

A or C

Other

A or C

Other

A or C

Other

A or C

Other

A or C

Other

A or C

Other

A or C

Other

Asherson

   

X

X

X

        

Banaschewski

X

 

X

X

 

X

X

X

X

     

Buitelaar

X

X

X

X

X

X

 

X

X

     

Coghill

X

X

X

X

X

X

  

X

 

X

   

Danckaerts

X

 

X

X

X

X

    

X

 

X

X

Döpfner

X

X

X

X

 

X

X

X

X

 

X

   

Faraone

  

X

X

X

X

  

X

X

 

X

X

X

Rothenberger

X

 

X

X

X

X

X

X

  

X

   

Santosh

X

 

X

X

 

X

        

Sergeant

  

X

X

X

X

X

 

X

     

Sonuga-Barke

X

X

X

X

 

X

  

X

     

Steinhausen

X

 

X

X

          

Taylor

              

Zuddas

X

 

X

X

X

X

  

X

 

X

  

X

  1. Note—A or C = served in an advisory or consultancy role either personally or for ones employer. This includes advisory boards
  2. Other—Paid public speaking/conference attendance support/unrestricted research support/meeting or conference grants

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Banaschewski, T., Coghill, D., Santosh, P. et al. Long-acting medications for the hyperkinetic disorders. Eur Child Adolesc Psychiatry 15, 476–495 (2006). https://doi.org/10.1007/s00787-006-0549-0

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