OBJECTIVES : To assess cardio-metabolic events (CMEs) over 3 years after the atypical antipsychotics (AAPs) prescription in patients with/without predisposing conditions (PCs) for CMEs and related costs in the Italian National Health System (NHS) perspective.

METHODS : From the ReS database, among adults with at least one AAP prescription in 2015 (index date), new AAP users were identified by the absence of antipsychotic prescriptions in two previous years. They were split according to the presence/absence of CMEs (diabetes, cerebrovascular and ischemic heart disease) and PCs (hyperglycaemia, dyslipidaemia and obesity). Subjects without CMEs but with PCs (A) and those without CMEs/PCs (B) were paired 1:1 with controls (same clinical status but without any AAPs prescriptions). The 3-year CME probability (Kaplan Meier survival curves), the amount of AAPs prescribed up to 1 year before the CME, and annual healthcare costs (pharmaceuticals, hospitalizations and outpatient specialist services) were described in the NHS perspective.

RESULTS : Out of >4 million adults of the 2015 ReS database, 50,893 patients (1.2%) with at least one AAP prescription were selected. New users were 12,128 (incidence: 2.8 x1,000). The 3-year CME probability was 17.0% and 7.9%, respectively for cohort A and B, vs 13.7% and 5.2% for controls (p<.01). Throughout 1 year before the CME, 74.0% and 79.2% received one AAP, while 1.3% and 0.6% received 2 AAPs, cohorts A and B respectively. The annual average per capita NHS cost was €7,171 (A) and €5,268 (B), vs €6,196 and €5,776 (respective controls). Hospitalizations were key cost drivers in all cohorts.

CONCLUSIONS : This real-world evidence (RWE) analysis outlined the CME probability of over 3 years according to the presence/absence of PCs in new users of AAPs and related costs, in the perspective of the NHS. This findings showed RWE at the time of a first AAP prescription and in the presence of specific patients’ cardio-metabolic profiles.