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



To describe new users of atypical antipsychotics (APs) in terms of sociodemographic characteristics, cardio-metabolic risk profile, prescription patterns, healthcare costs and cardio-metabolic events over the 24 months after treatment initiation.


Atypical AP new users were selected from the ReS database and grouped into three: patients already affected by cardio-metabolic 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.


Thirty-two thousand thirty-four new users of atypical APs were selected (median age 69). The 22.3% had cardio-metabolic 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.

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The study was partially supported by an unrestricted grant from Angelini S.p.A.

Author information




CP, LD, GR and APM conceived of the study. LD and GR analysed the data. CP, SC and CB wrote the first version of the article. AP, IE, APM, CB and NM contributed to the interpretation of the results and revised the manuscript. All authors read and approved the final manuscript.

Corresponding author

Correspondence to Carlo Piccinni.

Ethics declarations

Conflict of interest

The authors declare that they have no competing interests.

Ethical approval

This is an observational non-interventional database study, reutilising administrative data for the purpose of addressing a research question. The study was conducted under specific agreements between Fondazione ReS and Italian Regional/Local Health Facilities participating in the ReS database. All these institutions have general legal and ethical frameworks that allow them to conduct research by making secondary use of administrative data and provided sufficient guarantee of individual records’ deidentification.

Informed consent

Not applicable.

Additional information

Part of the results of this study has been presented as abstracts to the 32nd ECNP (European College of Neuropsychopharmacology) Congress (7–10 September 2019, Copenhagen) and to the national meeting of the Italian Society of Psychiatry (21–23 June 2019, Firenze).

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Piccinni, C., Dondi, L., Ronconi, G. et al. Real-world data on new users of atypical antipsychotics: characterisation, prescription patterns, healthcare costs and early cardio-metabolic occurrences from a large Italian database. Eur J Clin Pharmacol 76, 1301–1310 (2020).

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  • Atypical antipsychotic
  • Cardio-metabolic risk
  • Administrative data
  • Real-world evidence
  • Italy