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Relationships Between Functional Outcomes and Symptomatic Improvement in Atomoxetine-Treated Adult Patients with Attention-Deficit/Hyperactivity Disorder: Post Hoc Analysis of an Integrated Database

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Abstract

Background

Atomoxetine treatment is associated with improvements in functional outcomes in patients with attention-deficit/hyperactivity disorder (ADHD), although relationships between improvements in these outcomes and reductions in ADHD symptoms have not been comprehensively investigated in adults.

Objectives

The aim of this study was to assess relationships between functional outcomes and ADHD symptoms (primary objective), and to assess time courses of changes in functional outcomes from baseline to weeks 10 and 24 (secondary objective).

Methods

We analyzed data pooled from seven Eli Lilly-sponsored placebo-controlled trials of atomoxetine in adults with ADHD that had Conners’ Adult ADHD Rating Scales–Investigator Rated: Screening Version (CAARS-Inv:SV) total scores and functional outcome data at baseline and at week 10. Two trials also had these data at week 24. Patients were included in these pooled analyses if they had a CAARS-Inv:SV total score at baseline and at one or more post-baseline visits at weeks 10 or 24, or had post-baseline scores that would allow missing scores at weeks 10 or 24 to be imputed. To address the primary objective, changes in functional outcomes during treatment with atomoxetine versus placebo were assessed using last observation carried forward (LOCF) analysis of covariance (ANCOVA) and mixed-effects model repeated measures (MMRM) analysis, and correlations between score changes in CAARS-Inv:SV total and functional outcomes were assessed using Spearman’s rank correlation coefficient (r) at weeks 10 and 24. The secondary objective was addressed using MMRM.

Results

At baseline, patients generally had moderately severe or worse ADHD symptoms (based on CAARS-Inv:SV total scores) and impaired functional outcomes (based on Adult ADHD Quality-of-Life [AAQoL], Behavior Rating Inventory of Executive Function–Adult Version [BRIEF-A], Sheehan Disability Scale [SDS], and 36-item Short-Form Health Survey [SF-36] scores). These baseline characteristics were comparable in the atomoxetine and placebo groups. For atomoxetine versus placebo, statistically significant improvements were detected in AAQoL total and subscores at weeks 10 and 24, and in BRIEF-A Self-Report scores at week 10, but not in BRIEF-A Informant Report or SDS scores at week 10 (no BRIEF-A or SDS data were available at week 24), and not in SF-36 at weeks 10 or 24. All functional improvements were gradual. During treatment with atomoxetine, there were moderate correlations between reductions in CAARS-Inv:SV total scores and increases in AAQoL total and subscores at weeks 10 and 24 (r range −0.58 to −0.39; n = 394–545), and also with reductions in BRIEF-A Self-Report at week 10 (r = 0.49; n = 256). With placebo, moderate correlations were also found between reductions in CAARS-Inv:SV total scores and increases in AAQoL total and subscores at weeks 10 and 24 (r range −0.56 to −0.28; n = 321–542), and with reductions in BRIEF-A Self-Report at week 10 (r = 0.49; n = 271). However, correlations between changes in CAARS-Inv:SV and BRIEF-A Informant at week 10 were low for atomoxetine-treated patients (r = 0.25; n = 65), moderate with placebo (r = 0.42; n = 72), and there were low/no correlations between changes in CAARS-Inv:SV and functional outcome rating scales that are not specific to ADHD; that is, for atomoxetine-treated patients, SDS total r = 0.19 (n = 32 at week 10) and SF-36 r range − 0.20 to −0.01 (n = 51 at week 10, n = 183 at week 24).

Conclusions

Atomoxetine-treated adult patients experienced improvements in functional outcomes (AAQoL and BRIEF-A Self-Report) that correlated with reductions in ADHD symptoms. Although atomoxetine improved both the ADHD symptoms and functional outcomes, the correlation between symptoms and functional outcomes was low to moderate, suggesting that they measure overlapping but different aspects of the disorder. Hence, clinicians should assess not just ADHD symptoms, but also the functional impairments.

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Notes

  1. Correlations could be positive or negative, depending on the functional outcome rating scale. Negative correlations between reductions in CAARS-Inv:SV total and increases in AAQoL scores would indicate that less severe ADHD symptoms are associated with better HRQoL and functional outcomes. Positive correlations between reductions in CAARS-Inv:SV scores and increases in BRIEF-A scores would indicate that less severe ADHD symptoms are associated with better functional outcomes.

  2. No BRIEF-A Self-Report, BRIEF-A Informant Report, or SDS scores were available at Week 24.

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Authors and Affiliations

  1. Medical Department, Eli Lilly, Brussels, Belgium

    Katrien De Bruyckere

  2. Medical Department, Lilly Research Centre, Eli Lilly, Erl Wood Manor, Sunninghill Road, Windlesham, Surrey, GU20 6PH, United Kingdom

    Chris Bushe

  3. Medical Department, Eli Lilly, Bad Homburg, Germany

    Christoph Bartel

  4. Global Statistical Sciences, Eli Lilly, Bad Homburg, Germany

    Lovisa Berggren

  5. Department of Psychiatry, Radboud University Medical Centre, Nijmegen, The Netherlands

    Cornelis C. Kan

  6. Paediatric Psychopharmacology, Department of Child and Adolescent Psychiatry and Psychotherapy, Central Institute of Mental Health, Medical Faculty Mannheim, University of Heidelberg, Mannheim, Germany

    Ralf W. Dittmann

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Correspondence to Chris Bushe.

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Conflict of interest

Katrien De Bruyckere, Chris Bushe, and Christoph Bartel are current or former full-time employees and stock holders of Eli Lilly & Co. Lovisa Berggren is an Eli Lilly contractor. Cornelis Kan has participated in advisory boards, consultancy teams, and the Adult-ADHD Academy for Eli Lilly. Ralf W. Dittmann has received compensation for serving as consultant/speaker, and he/his institution has received research support/royalties from the following companies/organizations: European Union (EU; FP7 Programme), US National Institute of Mental Health (NIMH), German Federal Ministry of Health/Regulatory Agency (BMG/BfArM), German Federal Ministry of Education and Research (BMBF), German Research Foundation (DFG), Volkswagen Foundation, Boehringer Ingelheim, Ferring, Janssen-Cilag, Lilly, Lundbeck, Otsuka, Servier, Shire, Sunovion/Takeda. He owns Lilly stock.

Funding

These pooled analyses and the underlying source studies were funded by Eli Lilly and Co. Michael Riley and Barbara Boggetti from Trilogy Writing and Consulting GmbH, Frankfurt, Germany, provided medical writing support on behalf of Eli Lilly and Co.

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De Bruyckere, K., Bushe, C., Bartel, C. et al. Relationships Between Functional Outcomes and Symptomatic Improvement in Atomoxetine-Treated Adult Patients with Attention-Deficit/Hyperactivity Disorder: Post Hoc Analysis of an Integrated Database. CNS Drugs 30, 541–558 (2016). https://doi.org/10.1007/s40263-016-0346-3

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