With the advancement in medication, my Cardioloigist seems to be pretty optimistic that in 5-10 years there will be an alternative, so you wouldn't have to take cummodine or what have you.
I wanted to see how people here viewed that theory and if you think it is possible, wether it be in that time frame or 20-30 years from now. From what I understand the medical field is just progressing so quickly that I personally feel like its very possible, as does my cardiologist.
Would like to hear from you all on why you think it will or will not happen.
Thanks!
Well, as the others said, no one can predict the future, so planning for the here and now is generally far more reliable. But, in the interest of your question, I thought I'd at least offer a little perspective on one specific Warfarin alternative, already mentioned:
Boehringer Ingelheim announced in August plans for launching the "RE-ALIGN" trial to begin evaluation of Pradaxa in approximately 400 patients with mechanical heart valves (mitral and aortic). The scheduled start was October 2011 and completion was targeted for August 2012, currently still in recruitment. It is a only a preliminary (Phase II) study, so not yet at the effectiveness stage, targeted primarily for evaluating dosage algorithms. Then, there will be a follow-up study of the same patient group scheduled to complete in December 2018 to evaluate long term safety. The natural assumption would be that if all goes well, a full scale trial (randomized, much larger patient group, etc) to directly compare safety and effectiveness with Warfarin would begin to happen somewhere in between.
If you are not aware, Pradaxa went through this type of process for AFib patients. In late 2003, a fairly limited Phase II study began to evaluate dosages. Then, in late 2005, a full scale trial (RE-LY) began with a patient group of 18,000 that were followed for 3 years (through end of 2008) to compare safety and effectiveness with Warfarin. Then, in late 2010, Pradaxa was approved in the US as a "substitute" for Warfarin in A-Fib patients.
So, in answer to your question, anticoagulation alternatives are certainly in the works for mechanical valve patients. But, of course, no one knows at this time what the results of any of the studies or future trials will be. Mechanical valves and AFib are certainly not comparable conditions. And, at the end of the day, as Lyn pointed out, anticoagulants are anticoagulants, risk is inherent.
There have been several Pradaxa threads in the last few months, I won't go into much of that here, but there is also certainly a bit of controversy related to Pradaxa's approval and warp speed progression into A-Fib patient management. There are some hot button aspects that get a lot of focus, things such as antidote issues and cost, as has been mentioned. In my opinion, it's the much broader issue that is most important: will Pradaxa, or any other alternative, be as good as or better than Warfarin for mechanical valve patients, and what constitutes better - when, if ever, does convenience (dosage, monitoring, diet) trump safety?
For A-Fib, supposedly Pradaxa brought not just convenience, but also safety. But while "stroke reduction" is in all the headlines, there is a lot of fine print too. The FDA review did not actually grant Pradaxa superiority to Warfarin. One reason was that the higher stroke numbers of the Warfarin group were shown to be a product of poor INR control at many of the trial centers. So, in other words, Warfarin patients under good control were not shown to have an overall medical benefit from Pradaxa. So, will the scales shift (perhaps even in favor of Warfarin) with valve patients? Who knows...but certainly the possibility exists. Interestingly, the "RE-ALIGN" valve study is including not only the "standard" 150 mg dose of Pradaxa, but also a 300 mg dose. The 300 mg dose had been evaluated for A-Fib as well, but was eliminated due to higher frequency of major bleeding. In the A-Fib trial, major bleeding was comparable overall between Pradaxa 150 and Warfarin, so if the valve study should determine that a 300 mg dose is necessary due to heightened stroke risk (compared to A-Fib), the logical assumption would be that major bleeding increases, which potentially could shift medical benefit in favor of Warfarin.
Anyway, sorry to ramble, but you ask a good question, and wanted to try and guess a general trajectory for the future. Your cardiologist may just be right that there will be an alternative in 10 years. I really wonder, though, if it will be a truly better alternative for most from the most important standpoint of safety. Who knows for sure, though, it sure will be interesting to see what happens...
