Abstract
BackgroundAttention Deficit Hyperactivity Disorder (ADHD) is becoming an increasingly commonly diagnosed and treated childhood illness. Untreated ADHD is recognised as an independent risk factor for suicide-related events and deliberate self-harm and is reported more commonly in these populations. With the treatment of ADHD it is thus crucial to understand further any associations between pharmacological treatments and suicide-related events. Specific data for suicide-related events with stimulants have not been publically reported. Suicidal tendencies are, however, a contraindication to the treatment of patients with methylphenidate. Clinicians and patients may be helped by a meta-analytic comparison of suicide-related events in comparative randomised double-blind atomoxetine and methylphenidate clinical trials.MethodsSuicide-related events retrospectively mapped to the suicide-related event assessment instrument recommended by the FDA, the Columbia Classification Algorithm for Suicide Assessment (C-CASA), were evaluated in five double-blind placebo controlled comparative studies of atomoxetine and methylphenidate (n = 1024) of 6 to 9 weeks duration. The Mantel-Haenszel risk ratio and Mantel-Haenszel incidence differences have been calculated.ResultsIn total there were 5 suicide-related events, atomoxetine (ATX) 3/559 and methylphenidate (MPH) 2/465. There were no suicide attempts nor completed suicides. Meta-analysis finds no difference of a difference in risk between ATX and MPH with a Mantel-Haenszel risk ratio of 0.52 (95% CI; 0.06, 4.54).ConclusionIn the only reported meta-analysis of comparative suicide-related events between atomoxetine and methylphenidate, no significant evidence of a difference in risk has been found. These data may be informative to clinicians and patients when developing clinical guidelines.
Highlights
Atomoxetine was first licensed in Europe in 2004 and is currently the only non-stimulant medication licensed in Europe for the treatment of attention deficit hyperactivity disorder (ADHD) in children and adolescents
Recent cohort studies have reported that rates of suicidal ideation, deliberate self-harm (DSH) and suicide are significantly increased in untreated Attention Deficit Hyperactivity Disorder (ADHD) populations [4,5]
This analysis of the 5 acute randomised double-blind paediatric controlled trials of ATX and MPH of 6– 9 weeks duration finds that the risk of suicide-related events as assessed using FDA methodology finds no evidence of a difference in risk between atomoxetine and methylphenidate. To our knowledge this is the only comparator data-set in existence comparing suiciderelated events between these two common treatments for ADHD. [3,10,23]
Summary
Atomoxetine was first licensed in Europe in 2004 and is currently the only non-stimulant medication licensed in Europe for the treatment of attention deficit hyperactivity disorder (ADHD) in children and adolescents. Recent cohort studies have reported that rates of suicidal ideation, deliberate self-harm (DSH) and suicide are significantly increased in untreated ADHD populations [4,5]. An analysis of six prospective studies measuring annual suicide rates reported a comparative risk of 2.91 for males (5–24 years) in comparison to the general population [4], suggesting that ADHD may increase the severity of comorbid conditions (conduct disorder and depression). Anti-social behaviour, depression, and anxiety were found to be independently associated with self-harm. These comorbid disorders are commonly found in ADHD populations [4]. Untreated ADHD is recognised as an independent risk factor for suicide-related events and deliberate self-harm and is reported more commonly in these populations. Clinicians and patients may be helped by a meta-analytic comparison of suicide-related events in comparative randomised double-blind atomoxetine and methylphenidate clinical trials
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