RESUMEN
BACKGROUND: Attention-deficit/hyperactivity disorder (ADHD) is associated with significant impairment in multiple functional domains. This trial evaluated efficacy in ADHD symptoms and functional outcomes in young adults treated with atomoxetine. METHODS: Young adults (18-30 years old) with ADHD were randomized to 12 weeks of double-blind treatment with atomoxetine (n = 220) or placebo (n = 225). The primary efficacy measure of ADHD symptom change was Conners' Adult ADHD Rating Scale (CAARS): Investigator-Rated: Screening Version Total ADHD Symptoms score with adult prompts. Secondary outcomes scales included the Adult ADHD Quality of Life-29, Clinical Global Impression-ADHD-Severity, Patient Global Impression-Improvement, CAARS Self-Report, Behavior Rating Inventory of Executive Function-Adult Version Self-Report, and assessments of depression, anxiety, sleepiness, driving behaviors, social adaptation, and substance use. RESULTS: Atomoxetine was superior to placebo on CAARS: Investigator-Rated: Screening Version (atomoxetine [least-squares mean ± SE, -13.6 ± 0.8] vs placebo [-9.3 ± 0.8], 95% confidence interval [-6.35 to -2.37], P < 0.001), Clinical Global Impression-ADHD-Severity (atomoxetine [-1.1 ± 0.1] vs placebo [-0.7 ± 0.1], 95% confidence interval [-0.63 to -0.24], P < 0.001), and CAARS Self-Report (atomoxetine [-11.9 ± 0.8] vs placebo [-7.8 ± 0.7], 95% confidence interval [-5.94 to -2.15], P < 0.001) but not on Patient Global Impression-Improvement. In addition, atomoxetine was superior to placebo on Adult ADHD Quality of Life-29 and Behavior Rating Inventory of Executive Function-Adult Version Self-Report. Additional assessments failed to detect significant differences (P ≥ 0.05) between atomoxetine and placebo. The adverse event profile was similar to that observed in other atomoxetine studies. Nausea, decreased appetite, insomnia, dry mouth, irritability, dizziness, and dyspepsia were reported significantly more often with atomoxetine than with placebo. CONCLUSIONS: Atomoxetine reduced ADHD symptoms and improved quality of life and executive functioning deficits in young adults compared with placebo. Atomoxetine was also generally well tolerated.
Asunto(s)
Inhibidores de Captación Adrenérgica/uso terapéutico , Trastorno por Déficit de Atención con Hiperactividad/tratamiento farmacológico , Propilaminas/uso terapéutico , Adolescente , Inhibidores de Captación Adrenérgica/efectos adversos , Adulto , Análisis de Varianza , Clorhidrato de Atomoxetina , Atención/efectos de los fármacos , Trastorno por Déficit de Atención con Hiperactividad/diagnóstico , Trastorno por Déficit de Atención con Hiperactividad/psicología , Método Doble Ciego , Función Ejecutiva/efectos de los fármacos , Humanos , Análisis de los Mínimos Cuadrados , Valor Predictivo de las Pruebas , Propilaminas/efectos adversos , Estudios Prospectivos , Escalas de Valoración Psiquiátrica , Puerto Rico , Calidad de Vida , Recuperación de la Función , Índice de Severidad de la Enfermedad , Factores de Tiempo , Resultado del Tratamiento , Estados Unidos , Adulto JovenRESUMEN
ABSTRACT We examined the effects of atomoxetine in Latino (n = 108) versus Caucasian (n = 1090) pediatric outpatients (aged 6 to <18 years) during the first 10-11 weeks of treatment in two multicenter, open-label trials. Mean modal doses were not significantly different in Latinos (1.22 mg/kg per day) versus Caucasians (1.27 mg/kg per day; p = 0.22). Both groups showed significant and similar improvements: Mean ADHD Rating Scale-IV-Parent Version: Investigator Administered and Scored (ADHDRS-IV-P:I) scores decreased by 54% in Latinos (40.9-18.9; p < 0.001) and by 52% in Caucasians (37.7-18.2; p < 0.001). Other efficacy measures, such as Conners' Parent Rating Scale-Revised: Short Form (CPRS-R:S) and Clinical Global Impressions-ADHD-Severity (CGI-ADHD-S), demonstrated similar and significant decreases. The only significant between-group difference was a greater decrease in the ADHDRS-IV-P:I Hyperactive/Impulsive subscale at weeks 8-11 for Latinos; however, Latinos had higher baseline scores compared with Caucasians. This was not demonstrated in the CPRS-R:S Hyperactivity subscale. There was a significantly higher frequency of CYP2D6 slow metabolizers in Caucasians compared with Latinos. Caucasians reported significantly more abdominal and throat pain, whereas Latinos reported more decreased appetite and dizziness, but no differences in other common adverse events were reported. No suicidal behavior was reported in either group. We found that Latino and Caucasian children with attention-deficit/hyperactivity disorder (ADHD) exhibit a similar pattern of efficacy and tolerability with atomoxetine. The lack of placebo controls was a limitation of this study.