| アブストラクト | 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. Results: A total of 244,149 individual case safety reports (ICSRs; 431,354 ADRs) related to OACs were retrieved from EudraVigilance. About 80% of ICSRs refer to NOACs, especially rivaroxaban. Gastrointestinal (Gastr) and central nervous system (Nerv) disorders were the most represented categories. More than 90% of ADRs were serious and almost 9% fatal, with the highest ROR reported for dabigatran. Both fatal and non-fatal ADRs reported for Vitamin K Antagonists (VKAs) differed from those reported for NOACs. Among the latter, dabigatran and rivaroxaban showed similar profiles, while apixaban differed from all other OACs, even in the case of fatal ADRs. Conclusions: As expected, data collected from EudraVigilance showed differences among drugs, probably related to their specific characteristics and/or the peculiar utilization in clinical practice. Further investigations are needed to better compare the safety profile of OACs. |
|---|
| 投稿者 | Olimpieri, Pier Paolo; Palumbo, Fanny Erika; Giuffrida, Gaetano; Milanetti, Edoardo; Gozzo, Cecilia; Scebba, Elisa Lucia; Romano, Giovanni Luca; Lombardo, Giovanni Enrico; Duminuco, Andrea; Vetro, Calogero; Castiglione, Davide Giuseppe; Palumbo, Giuseppe Alberto; Scarso, Salvatore; Drago, Filippo; Gozzo, Lucia |
|---|
| 組織名 | Italian Medicines Agency, 00187 Rome, Italy.;UOC Ematologia con Trapianto di Midollo, A.O.U. Policlinico "G. Rodolico"-S.;Marco, 95123 Catania, Italy.;Department of Physics, Sapienza University, Piazzale Aldo Moro 5, 00184 Rome,;Italy.;Radiology Unit, Humanitas Istituto Clinico Catanese, 95045 Catania, Italy.;Department of Clinical and Experimental Medicine, University of Messina, 98125;Messina, Italy.;Department of Medicine and Surgery, University of Enna "Kore", 94100 Enna, Italy.;Hematology and Bone Marrow Transplantation Unit, Hospital of Bolzano;(SABES-Azienda Sanitaria dell' Alto Adige), Teaching Hospital of Paracelsus;Medical University, 39100 Bolzano, Italy.;Radiology I Unit, University Hospital Policlinico "G. Rodolico"-S. Marco, 95123;Catania, Italy.;Department of Medical Surgical Sciences and Advanced Technologies "GF Ingrassia",;University Hospital Policlinico "G. Rodolico"-S. Marco, 95123 Catania, Italy.;Department of Infectious, Tropical Diseases and Microbiology, IRCCS Sacro Cuore;Don Calabria Hospital, 37024 Negrar di Valpolicella, Italy.;Department of Biomedical and Biotechnological Sciences, University of Catania,;95123 Catania, Italy.;Centre for Research and Consultancy in HTA and Drug Regulatory Affairs (CERD),;University of Catania, 95123 Catania, Italy.;Clinical Trial Unit, Azienda Ospedaliero Universitaria Policlinico "G.;Rodolico-S. Marco", 95123 Catania, Italy. |
|---|
