EFFECTS OF LONGER-TERM ATOMOXETINE TREATMENT IN ADOLESCENTS WITH ADHD

Objectives: Few longer-term studies of ADHD have focused on adolescents. We report the efficacy and safety of atomoxetine in adolescent subjects treated for up to 2 years.

Methods: Data from 13 atomoxetine studies (6 double-blind, 7 open-label) were pooled for subjects, ages 12–18, with DSM-Ivdefined ADHD.

Results: Of the 601 atomoxetine-treated subjects in this meta-analysis, 537 (89.4%) have completed 3 months of acute treatment. Two hundred fifty-nine (48.4%) are continuing atomoxetine treatment, of which 219 have completed at least 2 years of treatment. The mean dose of atomoxetine at endpoint was 1.41mg/kg/day. Mean ADHD Rating Scale-IV, Parent version, Investigator-administered and -scored total scores showed significant improvement (P<.001) over the first 3 months. Symptoms remained improved to 24 months without need for dosage escalation. During the 2-year treatment period, 99 (16.5%) subjects discontinued treatment due to lack of effectiveness and 31 (5.2%) due to adverse events. No clinically significant abnormalities were found in height, weight, mean laboratory values, blood pressure, pulse, or electrocardiography.

Conclusion: Two-year data from this ongoing study indicate that atomoxetine maintains efficacy among adolescents with ADHD, with no new or unexpected safety concerns and no clinically significant evidence of drug tolerance.