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 identification

• PURI:
  https://redirect.ema.europa.eu/resource/1000000261
• EU PAS number:
  EUPAS1000000261
• Study ID:
  1000000261
• Official title and acronym:
  Real world data on new users of atypical antipsychotics: characterization, prescription patterns, healthcare costs and early cardio-metabolic occurrences from a large Italian database
• DARWIN EU® study:
  No
• Study countries:
  Italy
• Study description:
  Purpose: 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.; ; Methods: Atypical AP new users were selected from the ReS database and grouped into three: patients already affected by cardiometabolic diseases (group A), patients without these clinical conditions but with predisposing conditions (group B) and patients without cardio-metabolic diseases and predisposing conditions (group C). Annual prescription patterns and healthcare costs were analysed. Subjects of groups B and C were matched with controls to compare the occurrences of cardio-metabolic events over 24 months.; ; 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).; ; Conclusion: 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.
• Study status:
  Finalised

Research institutions and networks

Institutions

Health Search, Italian College of General Practicioners

Italy

Fondazione ReS (Ricerca e Salute), CINECA partner

Italy

Study timelines

Date when funding contract was signed

Actual: 12/06/2018

Study start date

Actual: 12/09/2018

Date of final study report

Actual: 12/12/2018

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Angelini SpA

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable