DARWIN EU® - Antipsychotic prescribing in the general population in Europe: a descriptive analysis of trends and patient characteristics

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine, other:
  Common antipsychotics (ATC: N05A); Substances included: ; • Sulpiride; • Quetiapine; • Risperidone; • Olanzapine; • Haloperidol; • Aripiprazole; • Piamperone; • Prothipendyl; • Prochlorperazine; • Chlorprothixene; • Promazine; • Paliperidone; • Zuclopenthixol; • Clozapine; • Fluspirilene; • Amisulpride; • Fluphenazine; • Perphenazine; • Pimozide; • Ziprasidone
• Study drug International non-proprietary name (INN) or common name:
  ARIPIPRAZOLE

  OLANZAPINE

  PALIPERIDONE

  RISPERIDONE
• Anatomical Therapeutic Chemical (ATC) code:
  (N05A) ANTIPSYCHOTICS

  ANTIPSYCHOTICS

Population studied

• Short description of the study population:
  The study cohort will comprise all individuals on 1st of January of each year in the period 2013-2023 (or the latest available), with at least 365 days of data availability before the day they become eligible for study inclusion. Additional eligibility criteria will be applied for the identification of new users: ; 1. When overall, no prior use of any of the common antipsychotics will be required. In other words, users with prior use of any of the antipsychotics of interest will be excluded from the analysis.; 2. When stratified by specific antipsychotic drug, no prior use of the specific antipsychotic will be required. In other words, users with prior use of the same antipsychotic will be excluded from the analysis.

Study design details

• Study design:
  Retrospective cohort studies will be conducted using routinely collected health data from 6 databases.
• Main study objective:
  1. To characterise people with dementia (overall, vascular dementia and Alzheimer’s disease) with first ; use of common antipsychotics in terms of age, gender, indication, comorbidities. ; 2. To measure trends in the incidence of first use of common antipsychotic prescribing among people with ; dementia (overall, vascular dementia and Alzheimer’s disease) overall, by typical/atypical grouping and ; by top 20 most common drug substances. Results will be stratified by database, calendar year, age and ; sex. ; 3. To characterise first time users of common antipsychotic drug therapy after initiation in people with ; dementia (overall, vascular dementia and Alzheimer’s disease) by drug substance (in terms of initial ; dose and duration). ; 4. To measure overall survival in people with dementia (overall, vascular dementia and Alzheimer’s ; disease) with first use of common antipsychotic overall, for typical/atypical grouping and for top 20 ; most common drug substances.
• Setting:
  This study will be conducted using routinely collected data from 6 databases from 6 European countries. All databases were previously mapped to the OMOP CDM.; 1. SIDIAP (Spain, Primary Care Database) [Objective 1 to 4]; 2. IPCI (Netherlands, Primary Care Database) [Objective 1 to 4]; 3. DK-DHR (Denmark, National Registry) [Objective 1 to 4]; 4. IQVIA DA Germany (Primary Care database) [Objective 1 to 3]; 5. IQVIA LPD Belgium (Primary Care database) [Objective 1 to 3]; 6. NAJS (Croatia, National Registry) [Objective 1 and 2]

Documents

Study report

DARWIN EU_Report_P3-C1-012_Antipsychotics general population_V3.pdf