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 institution and networks

Institutions

Contact details

Letizia Dondi

Primary lead investigator
Study timelines

Date when funding contract was signed

Actual:

Study start date

Actual:

Date of final study report

Actual:
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