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

• Medicinal product name, 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.;
• Outcomes:
  The survival analyses reporting Kaplan-Meier curves utilised death as an outcome to evaluate 1-year survival probabilities for new users of antipsychotic drugs.
• Summary results:
  Our study aimed to characterise antipsychotic use among patients with dementia across six primary care; databases in Europe. The proportion of patients with dementia taking antipsychotics ranged between 17% (DK-DHR) to 78% (SIDIAP). We observed atypical antipsychotic initiation of risperidone and quetiapine, and typical antipsychotic use of haloperidol as the most commonly prescribed antipsychotics. Patients with dementia taking antipsychotics had high proportions of comorbidities, were more frequently female, and among other potential indications observed in addition to dementia, the most common were depression, insomnia and other sleep disorders. Trends in IRs among patients with dementia were stable for IPCI, DK-DHR, and IQVIA LPD Belgium, with decreasing trends in NAJS and increasing trends in SIDIAP and IQVIA DA Germany. Incident use of antipsychotics among patients with dementia was higher in those over 85 years of age compared to other; age groups for most databases, and typical antipsychotic rates were higher than atypical antipsychotic rates; in IPCI and NAJS. Use in men was consistently higher than women for most databases. Among the most prescribed antipsychotics, one-year survival was high. Survival was lowest among those taking the typical antipsychotic haloperidol in IPCI, SIDIAP, and DK-DHR. These results were consistent between different types of dementia of vascular and Alzheimer’s dementia.