Abstract
In the June 2013 issue of this Journal, we described compelling evidence for the use of three novel anticoagulants, including Dabigatran, on the basis of recent large multi-centre trials.1 We acknowledged the approval of NOACs over warfarin in the ESC update and ACCP guidelines, and foresaw the greater usage of these newer, promising, therapies for stroke prevention in non-valvular atrial fibrillation. In our review article, we also advised a degree of caution with NOACs, as ‘experience with these drugs is relatively limited and that there are no currently available agents to reverse their effect in case of major complications, such as bleeding’. At the time, the concern centred around lack of reversal agents, which was discussed in a letter to the Editor, reflecting repercussions felt in the wider medical community.2,3 We had examined and accepted the data from the RE-LY trial to show how NOACs were becoming more acceptable. In light of the emerging concerns regarding the RE-LY trial and Dabigatran, highlighted by a recent BMJ investigation, we review the debate to date, and ask whether or not we, alongside commissioning bodies, now need to retract support for the drug.
Highlights
In our review article, we advised a degree of caution with NOACs, as ‘experience with these drugs is relatively limited and that there are no currently available agents to reverse their effect in case of major complications, such as bleeding’
In light of the emerging concerns regarding the RE-LY trial and Dabigatran, highlighted by a recent BMJ investigation, we review the debate to date, and ask whether or not we, alongside commissioning bodies, need to retract support for the drug
In a reply to the BMJ article, it recalled that the data from the RE-LY trial, and post-marketing assessments recognised by the Food and Drug Adminstration (FDA) and EMA, Page 256 of 256 Kaba et al Global Cardiology Science and Practice 2014:41 have supported dabigatran as “an important medication that reduces the risk of stroke, when used as directed in appropriate patients with non-valvular atrial fibrillation (NVAF).”
Summary
We advised a degree of caution with NOACs, as ‘experience with these drugs is relatively limited and that there are no currently available agents to reverse their effect in case of major complications, such as bleeding’. In light of the emerging concerns regarding the RE-LY trial and Dabigatran, highlighted by a recent BMJ investigation, we review the debate to date, and ask whether or not we, alongside commissioning bodies, need to retract support for the drug.
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