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Pharmacotherapy for Attention-deficit–Hyperactivity Disorder
and the combination of the two.
142
In this study, children enrolled from ADHD symptoms” in two or more situations. Second, the ICD-
with ADHD (n=579) were randomly assigned to receive medication, 10 defines one syndrome encompassing all three core symptoms
behavioural therapy, combination treatment or standard community (i.e. inattention, hyperactivity and impulsivity), and the DSM-IV-TR
care over 14 months. While all four groups showed improvements in requires either inattention or hyperactivity/impulsivity or all three
ADHD symptoms, subjects in the combined and pharmacotherapy symptoms. When all three core symptoms are present, combined-
groups showed greater improvements than those in the other two type ADHD is diagnosed. Third, whereas the ICD-10 does not support
groups. The combined group showed improvement over the diagnosis of multiple co-morbid conditions with ADHD in favour of a
behavioural and community care groups. The medication and primary diagnosis of the other condition, the DSM-IV-TR allows
combined treatment groups did not show a difference. multiple co-morbid diagnoses.
148
Another key finding was that the medication group showed As a result of these differences, prevalence estimates and response
improvement over the community care group even though subjects to treatment choices may vary depending on the criteria
in the latter group were often treated with medication. This latter applied.
148,149
Recent European
147
and UK guidelines based on the
finding suggests that the more aggressive treatment of study health technological assessments of the UK National Institute of
investigators (e.g. higher doses) led to better outcomes. Health and Clinical Excellence (NICE) make a number of
recommendations regarding the diagnosis and treatment of
Differences in Treatment of Attention-deficit– ADHD.
150
These guidelines recommend that both the ICD-10 and the
Hyperactivity Disorder Between Europe and DSM-IV-TR definitions of ADHD should be used for diagnosis and
North America acknowledge that, although they differ in terms of the breadth of
In considering the differences and similarities between the symptoms that are defined, groups of patients who defined by
approaches to treating ADHD in Europe and North America, either set of criteria suffer from similar levels of impairment.
150
the relative role of pharmacotherapy versus other treatment
options is an important defining characteristic, along with Concerning overall scope and prioritisation of pharmacological and
differences in the availability of agents and the perceptions and non-pharmacological treatments, current US practice guidelines for
attitudes of clinicians. treatment of ADHD (as detailed above) differ from both European and
NICE recommendations in important ways. In the current NICE
Barriers to diagnosing and treating ADHD in the EU and North technological assessment, pharmacotherapy as a first-line treatment
America include country, state and regional variations in treatment should be reserved for patients with severe symptoms or those
algorithms and product availability.
28,143,144
Table 1 lists stimulant refusing or not responding to first-line group psychological and
agents available in the US and Europe. Clearly, medication options parent training interventions.
150
Additionally, when pharmacotherapy
differ considerably, with many more being available in the US. The is indicated, long-acting pharmacological treatments, including
limited number of options in Europe is to some degree related to stimulants and non-stimulants, should be available but should not
regulatory barriers that mitigate against the approval of some replace short-acting agents as initial pharmacological treatment for
agents, such as MAS. Under current regulations, MAS and MAS XR reasons of cost and flexibility and for assessment of optimal dose.
28,150
would be required to gain approval for each chemical entity in the These decisions appear to have been based on an assumption that if
mixture of amphetamine salts. Other issues that affect the use of all else was even, non-pharmacological approaches would be
medications throughout Europe are the varying mechanisms and inherently preferable to pharmacological approaches; however, no
regulations that determine public financing of healthcare and attempt is made to support these assumptions with evidence. It
medication costs in various countries and the requirement for should also be noted that consensus throughout Europe has not
staged treatment protocols that specify the use of IR stimulants as been attempted with the NICE guidelines.
initial pharmacotherapy. It is also the case that differing patenting
situations reduce the incentive for certain products developed in A recent European guideline that represented a broader
the US to be licensed in Europe. perspective recommends a balanced appraisal of all treatment
modalities for the mildly and moderately affected patient on a case-
Treatment paradigms and algorithms also differ between Europe by-case basis, with non-pharmacological and pharmacological
and North America. Treatment consensus guidelines from North interventions having equal footing as potential first-line choices.
28,147
American professional medical associations have concluded that This guideline still differs from US guidelines with respect to the
stimulant medications have the most evidence supporting efficacy primacy of stimulant medications and the use of long-acting agents
and safety in treating ADHD in children and remain the first choice as first-line treatment in childhood ADHD (except for very small
for pharmaceutical-based intervention.
51,123,145
In Europe, guidelines children) in the US,
51,123,145
related to the issues of availability and
for the diagnosis and treatment of ADHD differ from those in North regulatory treatment protocols mentioned earlier.
America.
28,143,146,147
Historically, in the EU the International
Classification of Diseases Tenth Revision (ICD-10) is most commonly Additionally, European and American regulators, physicians,
used to diagnose ADHD, whereas the Diagnostic and Statistical politicians and the general public may differ in how they weigh the
Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) costs and benefits of stimulant treatment and in their perceptions
is most commonly used in the US.
148,149
These diagnostic criteria differ of the characteristics and role of stimulant agents. Opinions
in three substantive ways. First, the ICD-10 requires pervasive regarding the place of stimulants in the treatment of ADHD vary, in
symptoms as defined by presence of the full syndrome in two part related to concerns by regulators, clinicians and politicians in
independent settings, whereas the DSM-IV-TR defines pervasiveness some parts of Europe about using stimulant medications in children
as “impairment in social, academic, or occupational functioning because of their potential for adverse effects on growth, fear of
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