Atomoxetine treatment for ADHD: younger adults compared with older adults.

OBJECTIVE: Atomoxetine is a nonstimulant medication for treating child, adolescent, and adult ADHD. This meta-analysis compared the effects in younger and older adults. METHOD: A post hoc analysis was conducted using data from two double-blind, placebo-controlled clinical trials. Data from patients aged 18-25 years were compared with data from patients older than 25 years. RESULTS: In younger adults (mean age = 21.7), atomoxetine produces greater improvement than placebo on the Conners' Adult ADHD Rating Scale's total ADHD symptom score (p = .041, effect size = .797) and the clinical global impressions severity (p = .006, effect size = 1.121). In older adults (mean age = 43.4 years), atomoxetine also produces significant benefit on the CAARS-Inv:SV (p < .001, effect size = .326) and CGI-ADHD-S (p < .001, effect size = .346). The study findings reveal response rates to be 56.4% and 47.8% for the younger and older adults, respectively (p = .188). Tolerability is similar although older adults reported more sexual side effects. CONCLUSION: Younger and older adults show similar improvements at endpoint. The effect size is higher in younger adults, but this is due primarily to greater variability of response in older patients.

Effects of atomoxetine on attention-deficit/hyperactivity disorder in clinical pediatric treatment settings: a naturalistic study.

BACKGROUND: Observational studies involving atomoxetine hydrochloride in the treatment of attention-deficit/hyperactivity disorder (ADHD) complement randomized controlled trials by assessing treatment effects in a usual-care setting and including a more heterogeneous patient population. OBJECTIVE: To provide data on the effectiveness of atomoxetine in a naturalistic treatment setting according to both physician and parent ratings. DESIGN AND METHODS: A prospective, observational (non-interventional), longitudinal, open-label study of patients (N = 627; mean age = 11 years) with ADHD (from 60 physicians' offices in the United States and Puerto Rico) whose physicians had decided to prescribe atomoxetine either as initial treatment or after trying another ADHD treatment (e.g., stimulants, antidepressants). Patients with a baseline visit and one post-baseline visit for up to 1 year were eligible. Atomoxetine administration, dosing, and timing of follow-up visits were at each physician's discretion. Physicians evaluated the effectiveness of atomoxetine using a single-item rating scale: the Physician Global Impression: ADHD Severity (PGI-ADHD-S) scale. RESULTS: The average reported duration of treatment was 21.2 (range 0-89) weeks. Over this period, treatment significantly lowered ADHD severity compared with baseline, with a mean change of -0.91 (95% confidence interval: -1.00 to -0.82; p < 0.001) on the PGI-ADHD-S scale. Physician-rated improvement was more marked in patients with more severe ADHD at baseline (p < 0.001). Most patients (59-69%) experienced consistent symptom control at all times of the day. ADHD severity was improved similarly in patients across comorbid conditions (e.g., anxiety, depression, learning disorders), chief complaints (e.g., school problems, emotional problems), and prior treatment with stimulants or other medications. By parent reports, 49% of patients had improved grades following atomoxetine therapy while 35% stayed the same, and improvement in behavior (according to parents' ratings) occurred in 49% of patients following atomoxetine therapy, whereas 31% stayed the same. CONCLUSION: Data captured in this study support the conclusion that atomoxetine was effective in reducing symptom severity, and improving progress toward treatment goals, in children and adolescents with ADHD treated in a naturalistic treatment setting. However, given the open-label, observational (non-interventional) design of this study, certain biases cannot be excluded.

Atomoxetine treatment for pediatric patients with attention-deficit/hyperactivity disorder with comorbid anxiety disorder.

OBJECTIVE: Research suggests 25% to 35% of children with attention-deficit/hyperactivity disorder (ADHD) have comorbid anxiety disorders. This double-blind study compared atomoxetine with placebo for treating pediatric ADHD with comorbid anxiety, as measured by the ADHD Rating Scale-IV-Parent Version: Investigator Administered and Scored (ADHDRS-IV-PI) and the Pediatric Anxiety Rating Scale (PARS). METHOD: Patients (ages 8-17 years) meeting DSM-IV criteria for ADHD and generalized anxiety disorder, separation anxiety disorder, and/or social phobia were randomized to 12 weeks of atomoxetine (n = 87) or placebo (n = 89). ADHDRS-IV-PI and PARS total scores were analyzed using analysis of covariance last observation carried forward and repeated-measures analyses. RESULTS: Sixty-six patients in each group completed the study. Mean ADHDRS-IV-PI total score improved significantly for atomoxetine (n = 55; -10.5, SD 10.6) relative to placebo (n = 58; -1.4, SD 8.3; p < .001). Mean PARS total score also improved significantly for atomoxetine (n = 55; -5.5, SD 4.8) relative to placebo (n = 58; -3.2, SD 5.0; p = .011). CONCLUSIONS: Atomoxetine was efficacious in reducing ADHD symptoms in patients who have ADHD with comorbid anxiety and was well tolerated. There was also a significant reduction in independently assessed anxiety symptoms using both clinician-rated and self-rated measures, which merits further investigation. Results support consideration of atomoxetine for the treatment of ADHD in youths who have ADHD with comorbid anxiety disorder. CLINICAL TRIAL REGISTRATION INFORMATION: The LYBP study, on which this article is based, was not registered at clinicaltrials.gov because the last patient visit occurred before July 1, 2005. Results, however, are publicly posted at lillytrials.com and clinicalstudyresults.org. The unique study ID at both sites is 6477a.