New oral anticoagulant prescription rate and risk of bleeding in an Italian region.

PURPOSE: The purpose of this study was to measure the prescription rate of new oral anticoagulants (NOACs) and to investigate whether there is an increased risk of bleeding associated with these medications in the 1 220 000-inhabitant Italian region Friuli Venezia Giulia.

METHODS: The administrative data of the Regional Health Information System, linkable with each other at the individual patient level through an anonymous stochastic key, were used as the source of information. Prescription rates for rivaroxaban, dabigatran, and apixaban were calculated in the regional population in 2014 and 2015, also stratified by age class and gender. A case-crossover analysis with pair-matched interval approach and a case-time-control analysis were conducted to assess the risk of hospitalization with a diagnosis of bleeding and prescription of NOACs.

RESULTS: In the regional population ≥18 years of age, 1626 NOACs prescriptions per 100 000 population-years were filled in 2014 and 3370 in 2015. Prescription rate increased with age and was greater in males than in females. Overall, being a current NOACs user was not associated with the risk of hospitalization for bleeding compared to being a nonuser. A nonsignificant increase in risk was observed among patients with low prescription intensity.

CONCLUSIONS: This study showed an increasing time trend in NOACs prescriptions NOACs in Friuli Venezia Giulia. In this Italian population, NOACs users had no significantly increased risk of bleeding events as compared with nonusers.