title: Assessing the burden of treatment-emergent adverse events associated with atypical antipsychotic medications.
abstract: Treatment of schizophrenia and major depressive disorder (MDD) with atypical antipsychotics (AAPs) show improved efficacy and reduced side effect burden compared with older antipsychotic medications. However, a risk of treatment-emergent adverse events (TEAEs) remains. TEAEs are hard to quantify and perspectives on the importance of TEAEs differ across patients and between patients and physicians. The current study is a qualitative assessment that investigates TEAEs of AAPs from both patient and physician perspectives to provide better understanding of the occurrence and burden of TEAEs associated with these medications.
  
  
  
  Focus groups comprised of patients with MDD and interviews with patients with schizophrenia were conducted at two qualitative research facilities, along with a physician focus group at one of the facilities. Information collected from patients included an exhaustive list of TEAEs experienced, and the frequency and level of bother of each TEAE; from psychiatrists, information included an exhaustive list of TEAEs based on personal observations and patient report, frequency of TEAEs, clinically important TEAEs, and levels of patient-perceived bother. Standard qualitative analysis methods were used to identify, quantify, characterize, and summarize patterns found in the data collected.
  
  
  
  A total of 42 patients (25 with MDD and 17 with schizophrenia) and 4 psychiatrists participated in the study. TEAEs reported as bothersome across both patients groups included cognitive issues, weight gain and/or increased appetite, low energy, extrapyramidal symptoms (EPS), and need to sleep/excessive sleep/excessive sleepiness. TEAEs considered more bothersome by patients with schizophrenia were weight gain, low energy, EPS, mental anxiety, and increased positive symptoms; those considered more bothersome by patients with MDD were cognitive issues, somnolence/sedation, and flat/restricted affect. TEAEs considered most clinically important by psychiatrists included metabolic syndrome, weight gain, neutropenia, hyperglycemia, and QT prolongation; those TEAEs considered most bothersome to patients from physicians' perspectives included weight gain, reduced sexual desire or performance, EPS, akathisia, and hormonal issues.
  
  
  
  The wide range of TEAEs that are both frequent and bothersome and the variation in perceived burden according to diagnosis highlight the need for a tailored TEAE-awareness approach when choosing an AAP.
authors.affiliation: CMP B CHU Clermont-Ferrand, Université Clermont-Auvergne, Clermont Ferrand, Cedex 1, France.
authors.forename: Pierre-Michel
authors.initials: PM
authors.lastname: Llorca
authors.affiliation: Laboratoire de Santé Publique Évaluation des Systèms de Soins et Santé Perçue, Université de la Méditerranée, Marseille 5, France.
authors.forename: Christophe
authors.initials: C
authors.lastname: Lançon
authors.affiliation: Lundbeck, Deerfield, IL, USA. AHRY@lundbeck.com.
authors.forename: Ann
authors.initials: A
authors.lastname: Hartry
authors.affiliation: RTI Health Solutions, Research Triangle Park, Charlotte, NC, USA.
authors.forename: T Michelle
authors.initials: TM
authors.lastname: Brown
authors.affiliation: RTI Health Solutions, Research Triangle Park, Charlotte, NC, USA.
authors.forename: Dana B
authors.initials: DB
authors.lastname: DiBenedetti
authors.affiliation: Otsuka Pharmaceutical Development Corporation, Princeton, NJ, USA.
authors.forename: Siddhesh A
authors.initials: SA
authors.lastname: Kamat
authors.affiliation: Lundbeck, Deerfield, IL, USA.
authors.forename: Clément
authors.initials: C
authors.lastname: François
mesh_terms: D000328:Adult; D000368:Aged; D014150:Antipsychotic Agents / Q000009:adverse effects*; D001291:Attitude of Health Personnel; D003865:Major Depressive Disorder / Q000188:drug therapy; D005260:Female; D017144:Focus Groups; D006801:Humans; D008297:Male; D008875:Middle Aged; D011570:Psychiatry; D036301:Qualitative Research; D012559:Schizophrenia / Q000188:drug therapy; D057566:Self Report; D055815:Young Adult
chemical_list: D014150:Antipsychotic Agents
keywords: Atypical antipsychotics; Major depressive disorder; Schizophrenia; Treatment-emergent adverse events