811 – Long-term safety and efficacy of atomoxetine in adult adhd japanese patients

Abstract

Introduction Research has shown that ADHD symptoms and functional impairment often persist beyond childhood into adulthood. Thus an effective therapy that can be tolerated over long-term use in adults is needed. This is the first long term safety and tolerability study of an adult ADHD medication in Asia. Objectives Assess long-term safety, tolerability, and efficacy of atomoxetine (ATX) in adult Japanese ADHD patients. Aims Demonstrate the safety and tolerability of long-term ATX. Methods ATX (40-120 mg/day) was evaluated based on integrated analyses of a 10 week double-blind (DB) study and a 48 week open-label long term (LT) extension study. Long-term safety and tolerability were assessed by adverse events, discontinuation rate, and vital-signs. Efficacy measures included change from baseline in Conners’ Adult ADHD Rating Scale- Investigator Rated (CAARS-Inv:SV) total symptoms score, behavior Rating Inventory of Executive Function (BRIEF-A), and Adult ADHD/QoL Measure (AAQoL). Results 233 patients took ATX (LT mean final prescribed dose: 108.3 mg/day). AEs leading to discontinuations were seen in 37 (15.9%) patients, the most common being nausea in 10 (4.3%) patients. Statistically significant baseline-to-endpoint reductions in mean CAARS-Inv:SV total symptoms score during in the DB study continued throughout the LT study. Similar reductions were seen in BRIEF-A Self Report scores. These findings along with AAQoL results indicated that patients perceived improvements in both QoL and Executive Function. Conclusions Long-term ATX treatment was shown to be generally safe and tolerable in Japanese adult ADHD patients. Results also suggested ATX improved ADHD core symptoms, QoL and Executive Functions.