Safety and Tolerability of Atomoxetine Over 3 to 4 Years in Children and Adolescents With ADHD

Donnelly, Craig L.; Bangs, Mark E.; Trzepacz, Paula T.; Jin, Ling; Zhang, Shuyu; Witte, Michael M.; Ball, Susan; Spencer, Thomas

doi:10.1097/chi.0b013e318193060e

Cited by 57 publications

(87 citation statements)

References 31 publications

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“…More data on suicide-related events have been published both from longerterm clinical trial follow-up and epidemiological databases, and conclude that cases of suicide-related events are reported in temporal association with ATX usage, although no completed suicides have been reported in clinical trials (Bangs et al, 2008;Davies et al, 2009;Donnelly et al, 2009;McCarthy et al, 2009b). These data are well known (Bangs et al, 2008).…”

Section: Discussionmentioning

confidence: 99%

“…This is exampled by a UK retrospective chart review (n=76) from 2006-2008 reporting combination usage of ATX and MPH in 20%; 45% had a comorbid diagnosis, and 53% were taking lower ATX doses than recommended in the SPC (Banerjee, 2009). Observational studies also have more potential for longer-term follow-up than RCTs (Donnelly et al, 2009). …”

Section: Discussionmentioning

confidence: 99%

“…There are no completed suicides in ATX ADHD studies (Donnelly et al, 2009). In a pooled analysis of 13 placebo-controlled trials and three open-label extension trials in 714 atomoxetine patients treated for more than 3 years, there were 1.5% suicidal ideations, 0.3% suicide attempts and 0.1% suicidal behaviours, involving 14/714 patients (Donnelly et al, 2009). In a 1-year PEM study shortly after the UK launch in 2004 in a cohort of 2544 patients, suicidal ideation was 0.9%, suicide attempt 0.3%, overdose 0.3%, and 1% deliberate self-harm (Davies et al, 2009).…”

Section: Safety and Tolerability Of Atomoxetinementioning

confidence: 99%

“…Data from ATX cohorts have been published from long-term, open-label safety studies (Donnelly et al, 2009), a 1-year Prescription Event Monitoring (PEM) study interim analysis (Davies et al, 2009), database analyses (Cooper et al, 2011;McCarthy et al, 2009b;Schelleman et al, 2011), and individual clinical trials (Thurstone et al, 2010;Waxmonsky et al, 2010). There are no completed suicides in ATX ADHD studies (Donnelly et al, 2009). In a pooled analysis of 13 placebo-controlled trials and three open-label extension trials in 714 atomoxetine patients treated for more than 3 years, there were 1.5% suicidal ideations, 0.3% suicide attempts and 0.1% suicidal behaviours, involving 14/714 patients (Donnelly et al, 2009).…”

Section: Safety and Tolerability Of Atomoxetinementioning

confidence: 99%

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Systematic review of atomoxetine data in childhood and adolescent attention-deficit hyperactivity disorder 2009–2011: Focus on clinical efficacy and safety

Bushe

Savill

2013

J Psychopharmacol

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Background: Clinicians obtain critical prescribing knowledge from clinical papers and review articles. This is the first published systematic review of clinical atomoxetine data covering 2009-2011. Objective: We aim to update clinicians on current clinical atomoxetine data with specific reference to time of onset of efficacy and maximal efficacy. These data may allow critical analysis of comparative efficacy between atomoxetine and stimulant medications. Methods: A formal systematic review of atomoxetine data from January 2009-June 2011 was conducted. The search term used was "atomoxetine" in the English language. The search yielded 747 citations from which 106 are clinical data. This paper includes clinical efficacy and safety data and excludes quality-of-life and review papers. Results: Atomoxetine has an onset of action within 4 weeks (possibly within 1 week in subsequent responders) but requires at least 12 weeks for full response to be demonstrated. Treatment-naïve cohorts (6-12 weeks) report effect sizes of 0.6-1.3. Using minimum 6-week clinical trial criteria, atomoxetine may demonstrate similar efficacy to methylphenidate comparing reduction in core ADHD symptoms in meta-analysis, although the diversity of the data makes interpretation complex. From epidemiological databases, cardiovascular and suicide-related events were similar to those seen in patients taking methylphenidate. Conclusions:Incremental response time to atomoxetine should be considered in the design of future comparative efficacy trials.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Safety and Tolerability Of Atomoxetinementioning

confidence: 99%

Section: Safety and Tolerability Of Atomoxetinementioning

confidence: 99%

See 2 more Smart Citations

Systematic review of atomoxetine data in childhood and adolescent attention-deficit hyperactivity disorder 2009–2011: Focus on clinical efficacy and safety

Bushe

Savill

2013

J Psychopharmacol

View full text Add to dashboard Cite

show abstract

“…Side effects including abdominal pain, vomiting, headache, constipation, nausea, loss of appetite, depressive mood, irritability, cardiac murmur, QT prolongation, hypertension, tachycardia, and wolf-parkinson-white syndrome have been reported in association with the use of atomoxetine [8][9][10].…”

Section: Discussionmentioning

confidence: 99%