Time-to-onset and -resolution of adverse events before/after atomoxetine discontinuation in adult patients with ADHD

Abstract

Background. Adults with attention-deficit/hyperactivity disorder treated with atomoxetine were examined for time-to-onset and -resolution of common treatment-emergent adverse events (TEAEs) and male sexual dysfunction, and for changes in blood pressure (BP) and heart rate (HR) upon atomoxetine discontinuation. Methods. 12-week open-label atomoxetine (40–100 mg/day) was followed by 12-week double-blind maintenance treatment (atomoxetine 80 or 100 mg/day). Responders were then randomized to atomoxetine (n = 266) or placebo (n = 258) for 25-week randomized withdrawal. Examined were (1) median time-to-onset and -resolution of TEAEs during atomoxetine treatment, and (2) within group, visitwise mean changes for sitting HR, systolic BP, and diastolic BP for the postrandomization placebo group. Results. Common adverse events (AEs) appeared early, within week 1 of atomoxetine treatment. Some AEs resolve relatively rapidly, whereas others have a more lingering course of resolution (including male sexual side effects); median resolution times were 3 – 53 days. BP and HR increases during atomoxetine treatment returned to baseline upon atomoxetine discontinuation. Conclusion. Atomoxetine is associated with common AEs, with 3- to 53-day median resolution times. Trial registration: ClincialTrials.gov – NCT00700427.

Keywords:

• Atomoxetine
• attention-deficit hyperactivity disorder
• adult
• cardiovascular changes
• adverse events
• male sexual dysfunction

Declaration of interest

The trial was funded and sponsored by Eli Lilly and Company and/or any of its subsidiaries, Indianapolis, IN, USA. H Upadhyaya, Y Tanaka, LA Kryzhanovskaya, R Escobar, and AJ Allen are full-time employees and stockholders of Eli Lilly and Company. P Trzepacz is a stockholder of Eli Lilly and Company and was a full-time employee of Eli Lilly and Company during the preparation of this manuscript. S Lipsius is a full-time employee of inVentiv Health Clinical, LLC, and JR Lane was a full-time employee of inVentiv Health Clinical, LLC, during the preparation of this manuscript. Eli Lilly and Company contracted inVentiv Health Clinical, LLC, for statistical, writing, and editorial services. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

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