Real world data on new users of atypical antipsychotics: characterization, prescription patterns, healthcare costs and early cardio-metabolic occurrences from a large Italian database

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

  Healthcare resource utilisation
• Data collection methods:
  Secondary data collection

Non-interventional study

• Non-interventional study design:
  Case-control

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (N05AE) Indole derivatives

  (N05AH) Diazepines, oxazepines, thiazepines and oxepines

  (N05AX) Other antipsychotics

Population studied

• Short description of the study population:
  Patients aged ≥ 18 years old and receiving in 2013 (accrual year) one or more prescription of atypical AP were identified by searching the pharmaceutical database.
• Age groups:
  Adult and elderly population (>18 years)

  Adults (18 to < 65 years)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Elderly (≥ 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)

Study design details

• Study design:
  Retrospective longitudinal case control study
• Main study objective:
  To describe new users of atypical antipsychotics (APs) in terms of sociodemographic characteristics, cardiometabolic; risk profile, prescription patterns, healthcare costs and cardio-metabolic events over the 24 months after treatment initiation.
• Setting:
  In-hospital and local outpatient setting in public and affiliated with SSN facilities.
• Summary results:
  Thirty-two thousand thirty-four new users of atypical APs were selected (median age 69). The 22.3% had cardiometabolic diseases, 14.8% had predisposing conditions and 62.9% had none of these. The 99.3% received monotherapy. The mean annual cost per patient was €2785, and the median cost was €1108. After 24 months, a cardio-metabolic event occurred in 11.5% of group B vs. 8.7% of the controls (p < .01), and in 5.0% of group C vs. 2.1% of the controls (p < .01).; Patients treated with atypical AP were on average old and, in a non-negligible amount, with cardio-metabolic disease or predisposing conditions. New users of atypical APs showed a significantly higher likelihood to develop a cardio-metabolic event early after treatment initiation.

Documents

Study publications

Real-world data on new users of atypical antipsychotics: characterisation, pres…