Key result
Rivaroxaban had the lowest risk index (RI <1) among the four direct oral anticoagulants evaluated in the Italian National Pharmacovigilance Network, indicating the best safety profile.
Why the study?
Head-to-head trials comparing different DOACs for safety and efficacy are lacking, and findings from meta-analyses and real-life studies remain inconsistent and unsatisfactory.
Which direct oral anticoagulant has the best safety profile based on adverse drug reaction reports in a real-world national database?
Observational
Yes
Which direct oral anticoagulant has the best safety profile based on adverse drug reaction reports in a real-world national database?
Based on the Italian National Pharmacovigilance Network database, rivaroxaban demonstrated the lowest risk index for adverse drug reactions among direct oral anticoagulants.
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.
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Lavalle et al. (2020) conducted an observational in Thromboembolism. Direct oral anticoagulants (rivaroxaban, dabigatran, apixaban, edoxaban) vs. Other direct oral anticoagulants was evaluated on Adverse drug reaction risk index (RI). Rivaroxaban had the lowest risk index (RI <1) among the four direct oral anticoagulants evaluated in the Italian National Pharmacovigilance Network, indicating the best safety profile.
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