A group of researchers from the European Society of Cardiology have found what they say is the best-documented alternative to the blood thinners warfarin and aspirin for the prevention of stroke in patients with a type of irregular heartbeat known as atrial fibrillation. But the most preferred drug has yet to be approved for use in the United States.
Recently published results of this new research say Apixaban (Eliquis), made by Pifzer and Bristol-Myers Squibb, “has been shown to be superior compared with warfarin concerning the reduction of stroke and mortality in combination with a reduction in major bleeding, with a bleeding risk similar to that of low-dose aspirin, and with better tolerability than both these alternatives, albeit with no reduction in ischemic stroke compared with warfarin.”
Eliquis was up for review last month by the Food and Drug Administration (FDA), but the agency opted to delay that decision until late June. It is speculated that the agency’s decision to delay the review of Eliquis was due to safety issues surrounding the blood thinner Pradaxa (dabigatran), made by Boehringer Ingelheim.
Pradaxa was approved by the FDA for the prevention of strokes in patients with atrial fibrillation in October 2010. Since then, there have been mounting reports of bleeding episodes associated with the drug, some of which resulted in death.
Researchers with the European Society of Cardiology say that Pradaxa also reduced the risk of strokes in patients compared to warfarin, but noted that the drug has been associated with some specific side effects “such as an increased rate of dyspepsia (stomach discomfort) and gastrointestinal bleeding, a trend toward increased risk of myocardial infraction (heart attack), and a dependence on normal or only moderately impaired renal function for its elimination.”
Most bleeding episodes with warfarin can be countered with an antidote, but researchers pointed out that the newer drugs, while more effective at preventing strokes in specific patient populations, have no reversal agents. When bleeding problems occur, doctors have few options beyond administering activated charcoal for absorbing the drug from the stomach or, in the case of Pradaxa, ordering hemodialysis.