February 10, 2015 | By Márcio Barra
INFARMED published in its news bulletin a study providing an overview of the consumption trends of anticoagulant therapy in Portugal, from 2010 to 2013. 1 The report shares some interesting numbers, especially when considering the new molecules that have been released during the timeframe, namely the new oral anticoagulants (NOACs). The full version is supposedly available in the regulators website, but unfortunately I was unable to find it.
In the last 5 years, the NOACS, of which there are the direct inhibitors of factors IIa (Dabigatran, commercial name Pradaxa) or factor Xa (Rivaroxaban, commercial name Xarelto, and Apixaban, commercial name Eliquis), have been granted European and US marketing authorization for the prevention of thrombotic events, such as stroke and systemic embolism, in high-risk adult patients. A third factor Xa inhibitor, Edoxaban (commercial name Savaysa) was recently approved in the USA by the FDA for the prevention of stroke and embolic events in patients with non-valvular atrial fibrillation. These drugs overcome some limitations associated with the traditional oral and parenteral anticoagulants, such as Warfarin and Low Molecular Weight Heparins, such as frequent monitoring of INR. As for efficacy, NOACs’ efficacy across a whole spectrum of prothrombotic conditions is, at least, non-inferior to the standard care. 2
Concerning safety, as any other new drug in the market, there are still unknowns associated with these drugs, alongside the fact that, unlike established agents such as Warfarin, at the moment there is no antidote available to reverse the anticoagulant effect. (Boehringer Ingelheim has an antidote currently in clinical development, idarucizumab. Initial Phase I study results appear promising. 3
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