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.
My post is here: Apixaban (Eliquis) was supposed to beat dabigatran (Pradaxa) and rivaroxaban (Xarelto)…What gives?
Dr. Topol’s post: There is something strange about apixaban
JMM
Ken Grauer, MD says
June 27, 2012 at 6:26 amBELOW what I just posted regarding your post on theHeart.org:
THANKS for your post John. I’ve become much more skeptical of new drugs that initially look “great” – and subsequently evolve problematic. The situation becomes more complicated when FDA actions seem not necessarily directed in overall best interests (in this case – the lack of transparency both you & Dr. Topol allude to) – especially when billions of dollars are potentially involved … I’m much more an advocate of your last sentence: “With the new and novel blood thinners – going slow might be a good thing”.
jane says
June 27, 2012 at 10:23 amWow, you don’t fail to provide, do you? 😉 Thanks for writing this! It seems like all new blockbuster drugs come onto the market with the real side effects either unknown or actively concealed by the manufacturer. Given that, if I were so high-risk as to consider taking any of these drugs I’d prefer the unknown unknowns of apixaban to the known unknowns of dabigatran. I hate to say “I hope FDA has evidence of data-hiding,” but if they don’t, then they’re making a paternalistic choice with serious financial implications.