There was big news this week on the much-anticipated, but yet-to-be-evaluated novel blood thinner, apixaban (Eliquis).
The FDA wants more information from the ARISTOTLE trial. They have inquired about “data management and verification.” That sounds serious.
I made some comments about apixaban over at Trials and Fibrillations on theHeart.org.
Here’s the mystery: Apixaban boasts incredibly positive clinical trial data. Though the three novel blood thinners have not been compared head-to-head, they all have been matched against warfarin. Apixaban looked the best. In ARISTOTLE, patients treated with apixaban, compared to those on warfarin, had fewer strokes, less major bleeds and better overall mortality.
So why hasn’t the drug been approved? No one seems to know–not even influential cardiologist and editor of theHeart.org, Dr. Eric Topol. I would highly rrecommend listening to Dr. Topol’s short video clip on apixaban. He voices what many of us have been wondering: What about the cloak of secrecy, lack of transparency and overall mystery of apixaban?
If approved, apixaban would compete with warfarin, dabigatran (Pradaxa) and rivaroxaban (Xarelto). In my Trials and Fibrillations post, I present my take of the data on apixaban and then discuss how I thought it would fit into clinical practice. Using a cycling analogy, I expected apixaban would have been shielded from the brisk headwinds slowing the acceptance of dabigatran and rivaroxaban. What headwinds? Head over to theHeart.org and take a look.
Dr. Topol’s post: There is something strange about apixaban