Objective: To provide information on frequency, time to onset, and time to resolution of sexual and genitourinary (GU) treatment-emergent adverse events (TEAEs) reported during atomoxetine treatment in clinical trials. Methods: All adult (atomoxetine, n=1738; placebo, n=1576) and adolescent data (atomoxetine, n=329; placebo, n=209) from placebo-controlled atomoxetine ADHD trials were pooled for this analysis. (Time to onset and resolution of GU/sexual TEAEs were summarized and compared using Kaplan-Meier methods. Results: Overall, the baseline characteristics of the atomoxetine and placebo groups were similar. Profiles of GU/sexual TEAEs for atomoxetine appeared clinically similar to placebo in female and adolescent male patients. Adult male patients taking atomoxetine experienced more GU/sexual TEAEs compared to placebo, with libido decreased (4.6% vs. 3.0%), dysuria (3.7% vs. 1.5%), urinary hesitation (6.9% vs. 2.4%), urine flow decreased (2.5% vs. 0.6%), ejaculation disorder (2.8% vs. 1.1%), and erectile dysfunction (8.0% vs. 1.9%) being the most common. Time to onset of the most common TEAEs in adult male patients occurred within the first 2 weeks for GU TEAEs, and during the second and third week for erectile and ejaculation issues. Median time to resolution for these events ranged from 3-10 weeks after onset, depending on the event. Atomoxetine-treated patients with common GU/sexual TEAEs showed numerically higher percentages of discontinuations compared to placebo, but most GU/sexual TEAEs were not considered severe. Conclusions: In adult males taking atomoxetine a greater frequency of TEAEs tended to occur relatively early in dosing, have a shorter time to onset, and longer resolution times compared to placebo.
Douglas Kelsey, MD, PhD; Angelo Camporeale, MD; Kathleen Day, RN, MSN; Dustin Ruff, PhD; Jody Arsenault, PhD; David Williams, MS; Ahmed Deldar, PhD
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