Safety and tolerability of atomoxetine in treatment of attention deficit hyperactivity disorder in adult patients: An integrated analysis of 15 clinical trials

The safety profile of atomoxetine in the treatment of attention deficit hyperactivity disorder has been studied in many clinical trials. We performed an integrated safety analysis of 15 clinical trials in adults with attention deficit hyperactivity disorder. The analysis pooled patient data into three groups: acute placebo-controlled trials; long-term placebo-controlled trials; all trials. In total, 4829 adults (18–77 years, median: 36 years) were exposed to atomoxetine. Statistically significantly more atomoxetine-treated than placebo-treated patients experienced treatment-emergent adverse events (81.3% vs. 68.3% acute; 90.6% vs. 76.8% long term) and discontinued due to adverse events (8.9% vs. 4.0% acute; 17.9% vs. 6.3% long term). No statistically significant differences were observed in the proportion of patients experiencing serious adverse events. No previously unknown adverse events were identified. The most common adverse events included nausea, dry mouth, decreased appetite, insomnia and erectile dysfunction. Mean increases in heart rate (+5.2 beats per min) and blood pressure (systolic +2 mmHg, diastolic +1.9 mmHg) were modest. The proportion of patients experiencing clinically significant increases in blood pressure and heart rate at any time was statistically significantly higher with atomoxetine (systolic blood pressure 13–17%, diastolic blood pressure 37–40%, heart rate 42–43%) compared to placebo (systolic blood pressure 8–13%, dia...

Source: Journal of Psychopharmacology - December 10, 2014 Category: Psychiatry Authors: Camporeale, A., Porsdal, V., De Bruyckere, K., Tanaka, Y., Upadhyaya, H., Deix, C., Deberdt, W. Tags: Articles Source Type: research