DARWIN EU® - Antipsychotic prescribing in people with dementia 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
• Anatomical Therapeutic Chemical (ATC) code:
  (N05A) ANTIPSYCHOTICS

  ANTIPSYCHOTICS
• Medical condition to be studied:
  Dementia

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 and a prior diagnosis of dementia.

Study design details

• Study design:
  - New user cohort study (Objective 1 and 4, Patient-level antipsychotic utilisation); - Population level cohort study (Objective 2, Population-level antipsychotic drug utilisation) ; - New user cohort study (Objective 3, Patient-level characterisation);
• Main study objective:
  1. To characterise people with dementia (overall, vascular dementia and Alzheimer’s disease) with a first use of common antipsychotics in terms of age, gender, comorbidities, and indication; 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 the top 20 most commonly prescribed drug substances. Results will be stratified by database, calendar year, age and sex.; 3. To characterise first time users of common antipsychotic drug therapy in people with dementia (overall, vascular dementia and Alzheimer’s disease) by drug substance (in terms of dose and duration). Results will be stratified by drug route, age and sex.; 4. To measure overall survival in people with dementia (overall, vascular dementia and Alzheimer’s disease) with a first use of common antipsychotic overall, for typical/atypical grouping and for the top 20 most common drug substances.;