Key result
Non-vitamin K antagonist oral anticoagulants were associated with a higher disproportion of nervous system disorder-related adverse drug reactions compared to VKAs (ROR 3.98; 99% CI 1.50-10.53).
Why the study?
Do NOACs have a different profile of suspected adverse drug reactions compared to VKAs in a pharmacovigilance database?
Observational (n=794)
Do NOACs have a different profile of suspected adverse drug reactions compared to VKAs in a pharmacovigilance database?
Pharmacovigilance data from Portugal indicates an increasing trend in ADR reporting for oral anticoagulants, with NOACs showing a higher disproportion of nervous system-related ADRs compared to VKAs.
Answers are grounded in this paper and cite their sources.
ADR reporting for oral anticoagulants is rising, mainly with NOACs; leaves open whether nervous system disproportionality signals warrant targeted monitoring or trials.
OBJECTIVE: In this pharmacovigilance study, we aimed to determine the incidence of spontaneously reported suspected adverse drug reactions (ADRs) related to oral anticoagulants: non-vitamin K antagonist oral anticoagulants (NOACs; apixaban, dabigatran, edoxaban, rivaroxaban) and vitamin K antagonists (VKA) Research design and methods: In this retrospective observational study, we extracted all the individual case safety reports related to oral anticoagulants recorded in the Portuguese Pharmacovigilance Database (January 2010 to April 2015). The annual incidence of suspected ADRs was estimated using drug exposure data. Disproportionality of reporting ADR was addressed through reporting odds ratio (ROR) and 99% confidence intervals. RESULTS: We appraised 794 suspected ADR (78% related to NOACs). The annual number of ADRs increased overtime with 9 ADRs/million Defined Daily Dose (DDD) at the end of 2014. The incidence of NOACs ADRs decreased from 2012 onwards. VKA showed a disproportion in 'Investigation' (ROR 0.10, 99%CI 0.05-0.22) and 'Injury, poisoning and procedural complications' (ROR 0.36, 99%CI 0.19-0.69) ADRs compared with NOACs. NOACs had a higher significant disproportion of 'Nervous system disorders' related ADRs (ROR 3.98, 99%CI 1.50-10.53). CONCLUSIONS: Reporting of ADRs associated with oral anticoagulants (mainly NOACs), is increasing. Exploratory disproportion analyses showed an increase of reports of nervous system ADRs with NOACs, and INR-related ADRs with VKA.
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Caldeira et al. (2018) conducted an observational in Suspected adverse drug reactions related to oral anticoagulants (n=794). Non-vitamin K antagonist oral anticoagulants (NOACs) vs. Vitamin K antagonists (VKA) was evaluated on Disproportionality of reporting nervous system disorder-related ADRs (ROR 3.98, 95% CI 1.50-10.53). Non-vitamin K antagonist oral anticoagulants were associated with a higher disproportion of nervous system disorder-related adverse drug reactions compared to VKAs (ROR 3.98; 99% CI 1.50-10.53).
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