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

• 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
• 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]
• 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:
  Broadly, our study aimed to characterise antipsychotic use across six primary care databases in Spain, Belgium, Germany, Croatia, Denmark and Netherlands. We observed higher atypical antipsychotic initiation than typical initiation with the most common antipsychotics being quetiapine, sulpiride, risperidone and olanzapine. Compared to new users of atypical antipsychotics, new users of typical antipsychotics had higher proportions of comorbidities, with type 2 diabetes, obesity and hypertension being the most common. ; Depression, insomnia and other sleep disorders, and dementia appeared to be the most common indications for both types of antipsychotics based upon our definition. Incident use of antipsychotics was higher in those over 85 years of age compared to other age groups for all databases, with an increasing trend among this age group in SIDIAP, IQVIA DA Germany and DK-DHR databases. Among the most prescribed antipsychotics, one-year survival was lower among those in the ≥65-year-old age group compared to the 0 to 64 age group. Survival was lowest among those taking the typical antipsychotic haloperidol in IPCI, SIDIAP and DK-DHR. Taken together, our results suggest that off-label use of antipsychotics observed in the databases and countries studied is common