Carlo Lavalle1, Luca Di Lullo2, Antonio Bellasi3, Claudio Ronco4, Stefano Radicchia5, Vincenzo Barbera1, Gioacchino Galardo6, Agostino Piro1, Michele Magnocavallo1, Martina Straito1, Massimo Uguccioni7. 1. Department of Cardiovascular/Respiratory Diseases, Nephrology, Anesthesiology, and Geriatric Sciences, Policlinico Umberto I, Sapienza University of Rome, Rome, Italy. 2. Department of Nephrology and Dialysis, L. Parodi-Delfino Hospital, Rome, Italy, dilulloluca69@gmail.com. 3. Department of Research, Innovation, and Brand Reputation, Bergamo Hospital, ASST Papa Giovanni XXIII, Bergamo, Italy. 4. International Renal Research Institute, S. Bortolo Hospital, Vicenza, Italy. 5. Department of Medicine, Gubbio-Gualdo Tadino Hospital, Gubbio, Italy. 6. DAI Emergenza ed Accettazione, Anestesia ed Aree critiche, Policlinico Umberto I, Rome, Italy. 7. UOC Cardiologia 1, Azienda Ospedaliera San Camillo Forlanini, Rome, Italy.
Abstract
BACKGROUND: The availability of direct oral anticoagulants (DOAC) in clinical practice has transformed the health care provided to patients for the prevention and treatment of thromboembolism. Safety and efficacy data guide clinicians in the choice of the drug used. To date, no evidence is available from head-to-head trials comparing different DOAC with regard to safety and efficacy; information is mainly derived from several meta-analyses and real-life studies. Conclusions from these studies are inconsistent and unsatisfactory. The evaluation of self-reported adverse drug reactions (ADR) available from databases of drug-regulatory agencies such as the Italian Medicines Agency (AIFA) pharmacovigilance database represents a novel aid to guide decision-making. OBJECTIVE: To analyze potential suspected ADR of DOAC using a previously described risk index (RI) in daily clinical practice in Italy. METHODS: The National Pharmacovigilance Network database (from the AIFA website) was searched in order to retrieve information on all ADR related to oral anticoagulants occurring from 2013 to 2018. The ADR RI for each drug was calculated, where an RI = 1 indicates a balance between the percentage of ADR share and the percentage of market share for each DOAC; and an RI <1 indicates a rate of ADR lower than the rate of market share (safer DOAC). The following DOAC molecules were considered: dabigatran, rivaroxaban, apixaban, and edoxaban. RESULTS: The results showed that rivaroxaban is the DOAC with the lowest RI among the 4 molecules available today in Italy. CONCLUSIONS: Based on the RI, we identified rivaroxaban as the DOAC having the best safety profile.
BACKGROUND: The availability of direct oral anticoagulants (DOAC) in clinical practice has transformed the health care provided to patients for the prevention and treatment of thromboembolism. Safety and efficacy data guide clinicians in the choice of the drug used. To date, no evidence is available from head-to-head trials comparing different DOAC with regard to safety and efficacy; information is mainly derived from several meta-analyses and real-life studies. Conclusions from these studies are inconsistent and unsatisfactory. The evaluation of self-reported adverse drug reactions (ADR) available from databases of drug-regulatory agencies such as the Italian Medicines Agency (AIFA) pharmacovigilance database represents a novel aid to guide decision-making. OBJECTIVE: To analyze potential suspected ADR of DOAC using a previously described risk index (RI) in daily clinical practice in Italy. METHODS: The National Pharmacovigilance Network database (from the AIFA website) was searched in order to retrieve information on all ADR related to oral anticoagulants occurring from 2013 to 2018. The ADR RI for each drug was calculated, where an RI = 1 indicates a balance between the percentage of ADR share and the percentage of market share for each DOAC; and an RI <1 indicates a rate of ADR lower than the rate of market share (safer DOAC). The following DOAC molecules were considered: dabigatran, rivaroxaban, apixaban, and edoxaban. RESULTS: The results showed that rivaroxaban is the DOAC with the lowest RI among the 4 molecules available today in Italy. CONCLUSIONS: Based on the RI, we identified rivaroxaban as the DOAC having the best safety profile.
Authors: Carlo Lavalle; Marco Valerio Mariani; Agostino Piro; Michele Magnocavallo; Giampaolo Vetta; Sara Trivigno; Giovanni Battista Forleo; Domenico Giovanni Della Rocca; Massimo Uguccioni; Vincenzo Russo; Francesco Summaria; Luca Di Lullo Journal: J Clin Med Date: 2022-06-04 Impact factor: 4.964
Authors: Cristina Chimenti; Carlo Lavalle; Michele Magnocavallo; Maria Alfarano; Marco Valerio Mariani; Federico Bernardini; Domenico Giovanni Della Rocca; Gioacchino Galardo; Paolo Severino; Luca Di Lullo; Fabio Miraldi; Francesco Fedele; Andrea Frustaci Journal: ESC Heart Fail Date: 2021-12-16
Authors: Michele Magnocavallo; Giampaolo Vetta; Domenico G Della Rocca; Carola Gianni; Sanghamitra Mohanty; Mohamed Bassiouny; Luca Di Lullo; Armando Del Prete; Donatello Cirone; Carlo Lavalle; Cristina Chimenti; Amin Al-Ahmad; J David Burkhardt; G Joseph Gallinghouse; Javier E Sanchez; Rodney P Horton; Luigi Di Biase; Andrea Natale Journal: Card Electrophysiol Clin Date: 2022-01-22