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.

journal_name

Postgrad Med

journal_title

Postgraduate medicine

authors

Upadhyaya H,Tanaka Y,Lipsius S,Kryzhanovskaya LA,Lane JR,Escobar R,Trzepacz PT,Allen AJ

doi

10.1080/00325481.2015.1083394

subject

Has Abstract

pub_date

2015-01-01 00:00:00

pages

677-85

issue

7

eissn

0032-5481

issn

1941-9260

journal_volume

127

pub_type

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    abstract::The three most common types of vertiginous episodes area benign positional vertigo, postural vertigo, and endolymphatic hydrops. One of these conditions will be found in more than 90% of patients who present with vertigo as their main complaint. A clear understanding of the differences among these three entities will ...

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