One Unfortunate Fact These Two New Blood-Thinners Have In Common Is That Neither Has An FDA-Approved Antidote At Present Time
Earlier this month the medical journal Chest published online (Epub ahead of print) this article, "Direct comparison of dabigatran, rivaroxaban, and apixaban for effectiveness and safety in nonvalvular atrial fibrillation".
Also earlier this month, JAMA Internal Medicine published online (Epub ahead of print) this article, "Stroke, bleeding, and mortality risks in elderly Medicare beneficiaries treated with dabigatran or rivaroxaban for nonvalvular atrial fibrillation."
In both of these medical study reports it seemed that Xarelto (rivaroxaban) was more likely to be involved in a serious bleeding event as an adverse reaction than was either Pradaxa (dabigatran) or Eliquis (apixaban).
We previously touched upon the significance of these two new medical journal articles about a year ago with this post, "Is Eliquis Safer Than Xarelto And Pradaxa If It Causes Fewer Dangerous Major Bleeding Events -- Perhaps, But Neither Eliquis Nor Xarelto Have Any Specific Reversal Agent To Stop An Acute Bleed Once It Starts; Only Pradaxa Does".
To set up this latest report on the safety controversy surrounding these non-vitamin K antagonist oral anticoagulants (NOACs), as they are sometimes referred to -- but see also this recent related report, "What's in a Name? Debate on What to Call Novel Oral Anticoagulants" -- we want to provide some market-share information. From an October 21, 2016 CardioBrief article by Larry Husten, "Eliquis Nipping At Heels of Top-Selling NOAC Xarelto":
According to recent data from IMS Health, [Xarelto (rivaroxaban)] now has 46.5% of the NOAC market, compared with a 42.5% share for [Eliquis (apixaban)]. This represents a decline in share for rivaroxaban from a peak of about 60% of the market, while [Eliquis (apixaban)] has enjoyed continuous growth in its market share over the last few years. By contrast, dabigatran (Pradaxa) has 10.5% of the market and edoxaban (Savaysa) a minuscule 0.5% of the market.
So here we will be focusing on the two market-share leaders in this increasing popular class of blood-thinning drugs.
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As for what we know now, and what we need to learn going forward, we get these insights from this October 7, 2016 article, "More NOAC Comparisons See Higher Bleeding Risk With Rivaroxaban: Is the ‘Writing on the Wall’?":
The two new studies [published in the medical journal Chest and JAMA Internal Medicine] come close on the heels of an analysis by Danish researchers comparing [Pradaxa (dabigatran)], [Xarelto (rivaroxaban)], [Eliquis (apixaban)], and warfarin. In that analysis, [Pradaxa (dabigatran)] and [Eliquis (apixaban)] were associated with a significantly decreased risk of ICH compared with warfarin, but [Xarelto (rivaroxaban)] was not, although all three NOACs were as effective as warfarin at reducing stroke in atrial fibrillation patients. Laila Stærk, MD (Herlev and Gentofte University Hospital, Denmark), who presented that data at the recent European Society of Cardiology Congress 2016, spoke about the new data with TCTMD today, choosing her words carefully.
“We know the limitations of registry studies, which include the possibility of unmeasured confounders,” Stærk observed. That said, she continued, “We are seeing a tendency—and we have seen it now in different countries—suggesting that maybe all NOACs are not the similar in terms of safety.”...
To date there are no randomized head-to-head trials comparing the new agents, but that is about to change. Stærk told TCTMD that a new prospective, cluster randomized trial has just been announced in Denmark that will involve “almost all” hospitals in the country. Designed to run for 4 years, each hospital will just use one of the four approved NOACs ([Pradaxa (dabigatran)], [Xarelto (rivaroxaban)], [Savaysa (edoxaban)], and [Eliquis (apixaban)]) for the period of 1 year, then the next the next year, and so forth. At the end of the 4-year period, every participating hospital will have 1 year’s experience with each of the approved NOACs, with follow-up to continue for several years thereafter. Dubbed DEN-NOAC, the trial will be led by Casper Bang, MD (Rigshospitalet, Copenhagen, Denmark).
Lastly, as regards the current "no antidote" situation, you can read this relatively recent report, "Xarelto / Savaysa / Eliquis: Antidote Drug AndexXa Is Rejected By FDA In August 2016, Surprising Many Pharma Industry Observers (And Doctors?)".
Of course, we will continue to monitor the still-emerging safety issues surrounding Eliquis, Savaysa, and Xarelto.
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