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Comparative Study
. 2021 Jul;394(7):1477-1485.
doi: 10.1007/s00210-021-02073-7. Epub 2021 Mar 5.

Comparative study of adverse drug reactions among direct-acting oral anticoagulants and vitamin K antagonists using the EudraVigilance database

Alfredo Jose Pardo-Cabello  1 , Victoria Manzano-Gamero  2 , Juan de Dios Luna  3
Affiliations
Comparative Study

Comparative study of adverse drug reactions among direct-acting oral anticoagulants and vitamin K antagonists using the EudraVigilance database

Alfredo Jose Pardo-Cabello et al. Naunyn Schmiedebergs Arch Pharmacol. 2021 Jul.

Abstract

Our aim was to compare adverse drug reactions (ADRs) associated with direct-acting oral anticoagulants and vitamin K antagonists from the European EudraVigilance (EV) database. The EV database is the system for the analysis of information on suspected ADRs that are authorised, or being evaluated in clinical trials, in the European Economic Area. Registered ADRs (from the groups "Gastrointestinal disorders", "General disorders and administration site conditions", "Injury, poisoning and procedural complications", "Nervous system (NS) disorders" and "Vascular disorders") for apixaban, rivaroxaban, dabigatran and vitamin K antagonists (VKA) were collected by age group (< 65 years; 65-85 years and > 85 years) and by sex. The proportional reporting ratio (PRR) was used to compare ADRs in relation to the anticoagulants tested. A total of 274,693 ADRs were analysed. For gastrointestinal ADRs, patients treated with rivaroxaban and dabigatran (PRR 2.17 and 2.51, respectively) were at significantly higher risks than those treated with apixaban and VKA (PRR 1.27 and 1.47, respectively), while risks for vascular disorders were increased by all anticoagulants that were tested. Lastly, none of the anticoagulants significantly increased the risk of ADRs within the NS group. Rivaroxaban and dabigatran were associated with a significantly higher risk of gastrointestinal ADR than apixaban or VKA. All anticoagulants increased the risk of vascular pathology while none of them demonstrated significant increased risk of ADR to NS.

Keywords: Acenocoumarol; Adverse drug reaction; Apixaban; Atrial fibrillation; Dabigatran; Rivaroxaban; Warfarin.

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References

    1. Amin A, Stokes M, Makenbaeva D, Wiederkehr D, Wu N, Lawrence JH (2014) Estimated medical cost reductions associated with use of novel oral anticoagulants vs warfarin in a real-world non-valvular atrial fibrillation patient population. J Med Econ. 17:771–781 - DOI
    1. Anguita Sánchez M, Bertomeu Martínez V, Ruiz Ortiz M, Cequier Fillat Á, Roldán Rabadán I, Muñiz García J, Badimón Maestro L, Esteve Pastor MA, Marín Ortuño F, FANTASIIA study investigators (2020) Direct oral anticoagulants versus vitamin K antagonists in real-world patients with nonvalvular atrial fibrillation. The FANTASIIA study. Rev Esp Cardiol. 73:14–20 - DOI
    1. Athanasakis K, Boubouchairopoulou N, Karampli E, Tarantilis F, Savvari P, Bilitou A, Kyriopoulos J (2017) Cost effectiveness of apixaban versus warfarin or aspirin for stroke prevention in patients with atrial fibrillation: a Greek perspective. Am J Cardiovasc Drugs. 17:123–133 - DOI
    1. Connolly SJ, Ezekowitz MD, Yusuf S, Eikelboom J, Oldgren J, Parekh A, Pogue J, Reilly PA, Themeles E, Varrone J, Wang S, Alings M, Xavier D, Zhu J, Diaz R, Lewis BS, Darius H, Diener HC, Joyner CD, Wallentin L (2009) RE-LY steering committee and investigators. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med. 361:1139–1151 - DOI
    1. European Medicines Agency (EMA). Eudravigilance Expert Working Group (EV-Ewg) (2006) Guideline on the use of statistical signal detection methods in the eudravigilance data analysis system. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_proc... .

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