Adverse Drug Reactions during Real-Life Use of Direct Oral Anticoagulants in Italy: An Update Based on Data from the Italian National Pharmacovigilance Network.
Adverse drug reactions
Apixaban
Dabigatran
Edoxaban
Rivaroxaban
Journal
Cardiorenal medicine
ISSN: 1664-5502
Titre abrégé: Cardiorenal Med
Pays: Switzerland
ID NLM: 101554863
Informations de publication
Date de publication:
2020
2020
Historique:
received:
02
12
2019
accepted:
05
03
2020
pubmed:
1
5
2020
medline:
10
8
2021
entrez:
1
5
2020
Statut:
ppublish
Résumé
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. To analyze potential suspected ADR of DOAC using a previously described risk index (RI) in daily clinical practice in Italy. 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. The results showed that rivaroxaban is the DOAC with the lowest RI among the 4 molecules available today in Italy. Based on the RI, we identified rivaroxaban as the DOAC having the best safety profile.
Sections du résumé
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.
Identifiants
pubmed: 32353846
pii: 000507046
doi: 10.1159/000507046
doi:
Substances chimiques
Anticoagulants
0
Rivaroxaban
9NDF7JZ4M3
Types de publication
Journal Article
Review
Langues
eng
Sous-ensembles de citation
IM
Pagination
266-276Informations de copyright
© 2020 S. Karger AG, Basel.