BACKGROUND:Adults with attention-deficit/hyperactivity disorder treated withatomoxetine 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.
RCT Entities:
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.
Entities:
Keywords:
Atomoxetine; adult; adverse events; attention-deficit hyperactivity disorder; cardiovascular changes; male sexual dysfunction
Authors: Sharon B Wigal; Tim Wigal; Mary Hobart; Jessica J Madera; Ross A Baker; Eva Kohegyi; Anthony McKinney; Timothy E Wilens Journal: Neuropsychiatr Dis Treat Date: 2020-06-08 Impact factor: 2.570