Well, I'm always up for a discussion!
Let's see, start with a well known anticoagulant, affectionately known for being rat poison, then add a monopoly market and half a century's worth of frustration (much unwarranted of course) from patients and doctors alike, then add to the mix new exciting drugs (new is always better, right?) that have an FDA stamp of approval, a few headline grabbing clinical trial results (with disclaimers of course), nods of approval from physicians everywhere, and most importantly, drumroll please, extra
convenience! Well, is it any wonder then that Pradaxa, and likely soon Xarelto, is flying off the shelves (half a million patients in the first year) of pharmacies around the world! Who cares about safety when you have convenience after all!
Ok, in case you were wondering, there is some sarcasm in my opening, and I've also put some thought into the subject previously. For what it's worth, I'm not on any of these 3 drugs, so would like to think I'm generally unbiased. Someday I'm sure I will be, though, so I'm a very interested observer. I also have a family member with A-Fib so have done a fair amount of research, primarily focused on Pradaxa vs Warfarin.
There were several threads back in the Fall about Pradaxa, and I'm going to take the lazy approach here (sorry!) and refer you to those rather than trying to restate too much of what I included there:
http://www.valvereplacement.org/forums/showthread.php?38952-Dibagitran-Pradaxa-(-Do-not-Take-it-)
http://www.valvereplacement.org/forums/showthread.php?39056-From-Pradaxa-to-Coumadin-and-Back
http://www.valvereplacement.org/forums/showthread.php?39453-Blood-thinners-for-life
Long story short, the "yay" or "nay" vote on these new kids on the block might inevitably come down to a single factor for some such as "Great, no more blood testing!" or "No antidote, are you kidding me?". I'm much more of a proof is in the pudding type of guy, so for me, everything matters, and it generally all boils down to medical effectiveness in the end. Most importantly, not only is there no proof for
valve patients yet, but there's really no pudding either, clinical trials just getting started.
Now, for the approved A-Fib group, there are at least these options now. That's the key word, though: option. Despite what the myriad commercials or well-designed websites might lead you to believe, the FDA has not granted "superiority" to either Pradaxa or Xarelto. They are approved as "non-inferior". They both include a very important and similar disclaimer as well, something to the effect of efficacy results "not in comparison to Warfarin under good control". So, our best (Pradaxa and Xarelto) patients beat your worst (Warfarin) patients...seriously? :confused2:
Ok, anyway, this was supposed to be my lazy short version, but here I am going on and on again. Please note that I did a lot of research on Pradaxa but not Xarelto, but on brief glance, many of the same issues I mentioned for Pradaxa in those other threads seem somewhat similar. I should mention that one of the coolest resources I've found for all of this was the actual FDA Review Committee materials (basically the "evidence") that were put together as part of the Pradaxa approval. The general public only hears that Pradaxa is approved. They do not openly disseminate the "evidence analysis". There were a lot of critiques of the Pradaxa trial results in the FDA review (who seem to be extremely thorough) that generally no one would ever hear about.
So, does all of this mean I don't think Warfarin should/will ever be replaced for valve patients? No, not at all. I just think that to a large degree anticoagulants are anticoagulants, risk is inherent, and until the proof really is in the pudding, newer or easier isn't necessarily better for the most important factor of balancing stroke prevention and bleeding risk.
