Vitamin K Antagonists (VKAs) and Novel Oral Anticoagulants (NOACs) Safety Comparison Based on Data from EudraVigilance Database.

ABSTRACT: Background: Clinical trials comparing novel oral anticoagulants (NOACs) with warfarin reported a lower mortality rate and a reduced incidence of bleeding with NOACs. However, these studies do not allow for final conclusions about safety. Moreover, direct comparisons among NOACs are not available. Objectives: The aim of this study was to analyze data from EudraVigilance in order to compare OAC safety profiles. Methods: We searched for all suspected adverse drug reactions (ADRs) from OACs collected in the EudraVigilance up to March 2019. We calculated the reporting odds ratios (RORs) in order to assess the risk of reporting specific ADRs among drugs. Moreover, OAC safety profiles were investigated through correspondence analysis and visualized in contribution biplots.

SUBMITTER: Olimpieri PP 

PROVIDER: S-EPMC12563034 | biostudies-literature | 2025 Oct

REPOSITORIES: biostudies-literature