Objective: This analysis has identified and characterized new users of second-generation antipsychotics (SGA) in Italy and has assessed the occurrence of cardio-metabolic (CM) events over 3 years after the SGA starting therapy and the annual healthcare costs, in the perspective of the Italian National Health System (INHS).
Methods: Starting from the Fondazione ReS (Ricerca e Salute)'s database, adults treated with SGA in 2015 (index supply) were selected. By analyzing 2 previous years, treatment incidence and presence/absence of CM diseases or predisposing conditions (PC) to these events were defined and 3 cohorts were identified: A) with CM or predisposing conditions, B) only with PC, C) without neither CM nor predisposing conditions. Cohorts B and C were paired with patients with the same clinical profiles but without any SGA supply. Into cohorts and related paired groups, CM diseases/predisposing conditions occurred (cases) during the 3-year follow-up after the index supply were searched. Cases were compared with related control groups in terms of probability of CM disease/predisposing conditions occurrence (survival analysis to the event - Kaplan-Meier curves).
Results: Among more than 4 million adults, 12,218 were incident to SGA (2.8 x1,000): 2,732 composed cohort A (22.5%) with median age 80 (69;87), 1,492 cohort B (12.3%) with median age 77 (63;85), 7,904 cohort C (65.2%) with median age 60 (37;84). They were mostly females. The treatment incidence increased with age. The probabilities of CM events were: 15.8% and 13.3% among cases and controls of cohort B, and 7.5% and 5.1% among cases and controls of cohort C. Probabilities of predisposing conditions occurrence were 10% and 7.0% among cases and controls of cohort C. All differences were significant (p<0.01). The mean integrated healthcare cost was similar between case and control. Hospitalizations accounted for the most expenditure.
Discussion and conclusion: CM events or predisposing conditions occurrence in the elderly is both a clinical and an economic issue for the INHS. The proper therapeutic choice and monitoring of patient treated with antipsychotics must be encouraged.