title: Safety and tolerability of atomoxetine in treatment of attention deficit hyperactivity disorder in adult patients: an integrated analysis of 15 clinical trials.
abstract: 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%, diastolic blood pressure 29-34%, heart rate 21-26%). There was no increased risk of suicidal ideation or behaviour. Our findings confirm atomoxetine's known safety profile. From a safety perspective, atomoxetine is a useful treatment option for adults with attention deficit hyperactivity disorder.
authors.affiliation: Eli Lilly Italia, Sesto Fiorentino, Italy.
authors.forename: Angelo
authors.initials: A
authors.lastname: Camporeale
authors.affiliation: Eli Lilly Denmark A/S, Herlev, Denmark.
authors.forename: Vibeke
authors.initials: V
authors.lastname: Porsdal
authors.affiliation: S.A. Eli Lilly Benelux. N.V., Bruxelles, Belgium.
authors.forename: Katrien
authors.initials: K
authors.lastname: De Bruyckere
authors.affiliation: Lilly Research Laboratories, Indianapolis IN, USA.
authors.forename: Yoko
authors.initials: Y
authors.lastname: Tanaka
authors.affiliation: Lilly Research Laboratories, Indianapolis IN, USA.
authors.forename: Himanshu
authors.initials: H
authors.lastname: Upadhyaya
authors.affiliation: Eli Lilly Regional Operations, Vienna, Austria.
authors.forename: Claudia
authors.initials: C
authors.lastname: Deix
authors.affiliation: S.A. Eli Lilly Benelux. N.V., Bruxelles, Belgium deberdt_walter@lilly.com.
authors.forename: Walter
authors.initials: W
authors.lastname: Deberdt
mesh_terms: D000293:Adolescent; D018759:Adrenergic Uptake Inhibitors / Q000009:adverse effects* / Q000494:pharmacology / Q000627:therapeutic use; D000328:Adult; D000368:Aged; D000069445:Atomoxetine Hydrochloride; D001289:Attention Deficit Disorder with Hyperactivity / Q000188:drug therapy*; D001794:Blood Pressure / Q000187:drug effects; D002986:Clinical Trials as Topic; D004334:Drug Administration Schedule; D005260:Female; D006339:Heart Rate / Q000187:drug effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D011437:Propylamines / Q000009:adverse effects* / Q000627:therapeutic use; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D018759:Adrenergic Uptake Inhibitors; D011437:Propylamines; D000069445:Atomoxetine Hydrochloride
keywords: Atomoxetine; adult; attention deficit hyperactivity disorder; integrated analysis; safety