Safety and tolerability of atomoxetine hydrochloride in a long-term, placebo-controlled randomized withdrawal study in European and non-European adults with attention-deficit/hyperactivity disorder
Background and Objectives: Safety and tolerability of atomoxetine were studied in the largest double-blind, placebo-controlled, randomised withdrawal trial of atomoxetine (80 or 100 mg/day) in adults with attention-deficit/hyperactivity disorder (ADHD). Methods: Patients (N = 2017), 18 to 50 years o...
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| Published in | The European journal of psychiatry Vol. 27; no. 3; pp. 206 - 224 |
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| Main Authors | , , , , , , , , |
| Format | Journal Article |
| Language | English |
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Universidad de Zaragoza
01.07.2013
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| Abstract | Background and Objectives: Safety and tolerability of atomoxetine were studied in the largest double-blind, placebo-controlled, randomised withdrawal trial of atomoxetine (80 or 100 mg/day) in adults with attention-deficit/hyperactivity disorder (ADHD). Methods: Patients (N = 2017), 18 to 50 years of age, with ADHD were enrolled from 18 countries. Patients who responded to atomoxetine during a 12-week open-label treatment phase and maintained that response during a 12-week double-blind maintenance phase were randomised to atomoxetine (N = 266) or placebo (N = 258) for 25 weeks of double-blind treatment. Treatment differences were compared for serious adverse events (AEs), treatment-emergent AEs (TEAEs), discontinuation due to AEs, vital signs, body weight, and electrocardiograms. Adapted from the source document. |
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| AbstractList | Background and Objectives: Safety and tolerability of atomoxetine were studied in the largest double-blind, placebo-controlled, randomised withdrawal trial of atomoxetine (80 or 100 mg/day) in adults with attention-deficit/hyperactivity disorder (ADHD). Methods: Patients (N = 2017), 18 to 50 years of age, with ADHD were enrolled from 18 countries. Patients who responded to atomoxetine during a 12-week open-label treatment phase and maintained that response during a 12-week double-blind maintenance phase were randomised to atomoxetine (N = 266) or placebo (N = 258) for 25 weeks of double-blind treatment. Treatment differences were compared for serious adverse events (AEs), treatment-emergent AEs (TEAEs), discontinuation due to AEs, vital signs, body weight, and electrocardiograms. Adapted from the source document. Background and Objectives: Safety and tolerability of atomoxetine were studied in the largest double-blind, placebo-controlled, randomised withdrawal trial of atomoxetine (80 or 100 mg/day) in adults with attention-deficit/hyperactivity disorder (ADHD). Methods: Patients (N = 2017), 18 to 50 years of age, with ADHD were enrolled from 18 countries. Patients who responded to atomoxetine during a 12-week open-label treatment phase and maintained that response during a 12-week double-blind maintenance phase were randomised to atomoxetine (N = 266) or placebo (N = 258) for 25 weeks of double-blind treatment. Treatment differences were compared for serious adverse events (AEs), treatment-emergent AEs (TEAEs), discontinuation due to AEs, vital signs, body weight, and electrocardiograms. Results: During the 25-week double-blind treatment phase, discontinuations due to AEs were similar between atomoxetine and placebo (3.4% vs. 1.9%; P = .418). The percentage of patients experiencing >1 TEAE(s) was significantly higher for atomoxetine than placebo (47.0% vs. 37.6%; P = .034), but there were no significant differences for any individual TEAE. Diastolic blood pressure (-0.1 vs. -2.3 mmHg), heart rate (-1.4 vs. -5.3 bpm), and weight (-0.2 vs. 1.1 kg) were significantly different between atomoxetine and placebo (P <.001). There were no significant differences between atomoxetine and placebo in the frequencies of patients showing an increase from baseline >30 ms in Fridericia's QT correction (QTcF; 1.4% vs. 2.6%) or Bazett's QT correction (QTcB; 2.8% vs. 2.6%). During the entire study, no patient had a QTcF or QTcB >500 ms, or an increase from baseline >60 ms. Conclusions: This study demonstrated that atomoxetine exhibited an acceptable safety profile in adults with ADHD after 1 year of treatment, and no clinically meaningful safety-related rebound effects were observed following abrupt discontinuation after 24 weeks of treatment. |
| Author | Trzepacz, Paula Upadhyaya, Himanshu Lane, Jeannine R. Escobar, Rodrigo Ramos-Quiroga, J. Antoni Williams, David Allen, Albert J Camporeale, Angelo Tanaka, Yoko |
| AuthorAffiliation | Hospital Universitari Vall d'Hebron Universitat Autònoma de Barcelona Lilly Corporate Center Centro de Investigación Biomédica en Red de Salud Mental (CIBERSAM) inVentiv Health Clinical |
| AuthorAffiliation_xml | – name: Lilly Corporate Center – name: inVentiv Health Clinical – name: Universitat Autònoma de Barcelona – name: Centro de Investigación Biomédica en Red de Salud Mental (CIBERSAM) – name: Hospital Universitari Vall d'Hebron |
| Author_xml | – sequence: 1 givenname: Angelo surname: Camporeale fullname: Camporeale, Angelo – sequence: 2 givenname: Himanshu surname: Upadhyaya fullname: Upadhyaya, Himanshu – sequence: 3 givenname: J. Antoni surname: Ramos-Quiroga fullname: Ramos-Quiroga, J. Antoni – sequence: 4 givenname: David surname: Williams fullname: Williams, David – sequence: 5 givenname: Yoko surname: Tanaka fullname: Tanaka, Yoko – sequence: 6 givenname: Jeannine R. surname: Lane fullname: Lane, Jeannine R. – sequence: 7 givenname: Rodrigo surname: Escobar fullname: Escobar, Rodrigo – sequence: 8 givenname: Paula surname: Trzepacz fullname: Trzepacz, Paula – sequence: 9 givenname: Albert J surname: Allen fullname: Allen, Albert J |
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| Title | Safety and tolerability of atomoxetine hydrochloride in a long-term, placebo-controlled randomized withdrawal study in European and non-European adults with attention-deficit/hyperactivity disorder |
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