Cited by 191Attention Deficit Hyperactivity DisorderBlood Pressure and Hypertension StudiesPharmaceutical studies and practices

The DOI matches its Crossref record; 12 of the 12 references it cites were found in a registry or an index.

Cardiovascular Effects of Atomoxetine in Children, Adolescents, and Adults

Abstract

Background Atomoxetine is a highly specific presynaptic inhibitor of the noradrenaline (norepinephrine) transporter that was recently approved in the US for the treatment of patients with attention-deficit/hyperactivity disorder (ADHD). Adverse effects on the cardiovascular system, including abnormalities in heart rate, blood pressure, or cardiac rhythm have been associated with several noradrenergic medications.Objective To further elucidate the magnitude and impact of blood pressure and pulse elevations in patients taking atomoxetine.Study design Short-term cardiovascular safety in children, adolescents, and adults with ADHD was assessed in five randomised, double-blind trials (duration up to 10 weeks) with atomoxetine (n = 612) or placebo (n = 474). Long-term cardiovascular safety in children and adolescents (n = 169) was assessed in patients who entered an open-label extension or a blinded continuation following short-term treatment.Methods Adverse events, blood pressure, sitting pulse, and electrocardiograms (ECGs) were collected throughout the trials. QT intervals were corrected for heart rate by a data-specific correction factor (QTcD; derived from baseline ECGs) as well as standard methods.Results Atomoxetine treatment was associated with small but statistically significant increases in mean systolic blood pressure in adults and diastolic blood pressure in children and adolescents. Mean pulse rate increased for all atomoxetine treatment groups. The increases in blood pressure and pulse tended to occur early in therapy, stabilised, and returned toward baseline upon drug discontinuation. There was no significant difference between atomoxetine and placebo treatment groups in change in QTcD interval for all study populations. Palpitations in the adult patient population were the only significant cardiovascular adverse event (p = 0.037) occurring more frequently in the atomoxetine treatment group (3.7%) than in the placebo group (0.8%). Discontinuations due to cardiovascular-related events were very uncommon in the adult group, and did not occur in the child/adolescent group.Conclusion While atomoxetine has noradrenergic activity, increases in pulse and blood pressure were small and of little, if any, clinical significance. Atomoxetine was not associated with QT interval prolongation. Cardiovascular effects of atomoxetine were minimal, and atomoxetine was well tolerated in short- and long-term studies.

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Crossref · 10.2165/00002018-200326100-00006

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Metadata

Authors
Wernicke, J. F., Faries, D., Girod, D., Brown, J. W., Gao, H., Kelsey, D., Quintana, H., Lipetz, R., Michelson, D., & Heiligenstein, J.
Affiliations
  • Eli Lilly (United States) (US)
  • Louisiana State University Health Sciences Center New Orleans (US)
  • Encompass Health (United States) (US)
Corresponding author
Wernicke, Joachim F
Venue
Drug Safety
Published
2003
Volume
26
Issue
10
Pages
729-740
ISSN
0114-5916 (ISSN-L)
OpenAlex
W2094270069
Cited by
191
References
12
Citations by year
2026: 2 · 2025: 3 · 2024: 3 · 2023: 3 · 2022: 8 · 2021: 6 · 2020: 3 · 2019: 4 · 2018: 5 · 2017: 8 · 2016: 3 · 2015: 13 · 2014: 8 · 2013: 9 · 2012: 13
FWCI
6.85
Type
journal article
Language
en
Open access
closed
Locations
  • Drug Safety (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Health Sciences › Medicine › Psychiatry and Mental health › Attention Deficit Hyperactivity Disorder
  • Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Blood Pressure and Hypertension Studies
  • Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Pharmaceutical studies and practices
Keywords
atomoxetine, cardiovascular safety, attention deficit hyperactivity disorder, blood pressure, pulse rate, QT interval, palpitations, cardiovascular adverse events, children and adolescents, adults
MeSH terms
Atomoxetine Hydrochloride, Adolescent, Adult, Attention Deficit Disorder with Hyperactivity, Blood Pressure, Child, Double-Blind Method, Electrocardiography, Female, Heart Conduction System, Hemodynamics, Humans, Male, Propylamines, Randomized Controlled Trials as Topic

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