What level of evidence does the study on atomoxetine for adults with attention‑deficit/hyperactivity disorder (ADHD) and comorbid generalized anxiety disorder provide?

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Nível de Evidência do Estudo sobre Atomoxetina em Adultos com TDAH e Transtorno de Ansiedade Generalizada Comórbido

O estudo sobre atomoxetina em adultos com TDAH e transtorno de ansiedade generalizada comórbida fornece evidência de Nível 2 (ensaio clínico randomizado, duplo-cego, controlado por placebo). 1

Classificação da Evidência

A bula da FDA descreve um ensaio clínico de 16 semanas, duplo-cego, controlado por placebo, envolvendo 442 pacientes adultos (18-65 anos) que preencheram critérios do DSM-IV para TDAH adulto e transtorno de ansiedade social (23% também tinham Transtorno de Ansiedade Generalizada) 1. Este desenho de estudo representa:

  • Randomização: Pacientes foram randomizados após período de lead-in placebo de 2 semanas
  • Duplo-cego: Tanto pacientes quanto avaliadores desconheciam a alocação do tratamento
  • Controlado por placebo: Grupo controle adequado para comparação
  • Tamanho amostral robusto: 442 pacientes randomizados, com 413 completando o lead-in placebo

Características Metodológicas

O estudo utilizou:

  • Dosagem de atomoxetina iniciada em 40 mg/dia até máximo de 100 mg/dia (dose média diária de 83 mg ± 19,5 mg)
  • Desfecho primário medido pela Liebowitz Social Anxiety Scale (LSAS), instrumento validado
  • Demonstrou que atomoxetina não piorou a ansiedade nestes pacientes 1

Limitações a Considerar

Taxa de descontinuação significativa: Dos 413 pacientes que completaram o lead-in placebo duplo-cego, 149 (36,1%) descontinuaram o estudo 1. Esta alta taxa de descontinuação pode introduzir viés de atrito e limitar a generalização dos resultados.

Contexto com Outras Evidências

Um estudo aberto de 2011 com 29 pacientes adultos com TDAH e ansiedade generalizada parcialmente responsiva a ISRS/IRSN mostrou resultados positivos com atomoxetina adjuvante 2, mas este representa evidência de menor qualidade (Nível 4 - série de casos aberta, não controlada).

Portanto, o estudo descrito na bula da FDA representa a evidência de mais alta qualidade disponível (Nível 2) para esta população específica, embora a alta taxa de descontinuação exija cautela na interpretação dos resultados em prática clínica real.

References

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