Assessing the burden of treatment-emergent adverse events associated with atypical antipsychotic medications

BMC Psychiatry

Research Article

Pierre-Michel Llorca¹  Christophe Lançon²  Ann Hartry³  Clément François³  Siddhesh A. Kamat⁴  Dana B. DiBenedetti⁵  T. Michelle Brown⁵ 

[1] CMP B CHU Clermont-Ferrand, Université Clermont-Auvergne, Cedex 1, Clermont Ferrand, France;Laboratoire de Santé Publique Évaluation des Systèms de Soins et Santé Perçue, Université de la Méditerranée, Marseille 5, France;Lundbeck, Deerfield, IL, USA;Otsuka Pharmaceutical Development Corporation, Princeton, NJ, USA;RTI Health Solutions, Research Triangle Park, Charlotte, NC, USA;

关键词: Schizophrenia;    Major depressive disorder;    Atypical antipsychotics;    Treatment-emergent adverse events;   

DOI  :  10.1186/s12888-017-1213-6

 received in 2016-05-20, accepted in 2017-01-24,  发布年份 2017

来源: Springer

【 摘 要 】

BackgroundTreatment 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.MethodsFocus 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.ResultsA 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.ConclusionsThe 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.

【 授权许可】

CC BY   
© The Author(s). 2017