New Drug?

[clumsydancer]

I keep hearing from credible (my surgeon) that there is a drug on the cusp of FDA approval to replace Coumadin that is a once a day and INR checks once every six months. I failed to ask what this miracle drug is. Anyone know?

Nate

 

[dick0236]

This is news to me......and I just bought a years supply of strips, dammit LOL. Sounds good if it is true.

 

[ElectLive]

Hopefully you can get more detailed information on the specific drug from your surgeon, but more importantly, he or she likely needs to speak to this "miracle drug" in the true context of valve replacement. A once a day Coumadin "replacement" with FDA approval already exists: Xarelto. The catch is that it is only approved for a-fib patients without valve problems. Another Coumadin "replacement" - Pradaxa - was approved (under the same strict conditions) a year or so earlier and has garnered lots more attention.

For what it's worth, Pradaxa began the initial stages of clinical study in valve patients, not a trial, but a very small dosing study...basically the first phase of a 5-10 year process to FDA approval. In any case, that dosing study was pretty quickly halted after excessive amounts of "adverse events" - higher bleeding and clotting actually. There was a thread here that discussed it: http://www.valvereplacement.org/forums/showthread.php?41118-Study-of-dabigatran-in-mechanical-heart-valve-patients-halted.

Xarelto and Pradaxa are not the only ones, there are also 1 or 2 others, but I'm not aware of any even on the cusp of a full blown clinical trial for valve patients, much less FDA approval. I'm also of the personal opinion that FDA approval isn't really a slam dunk for valve patients anyway...the A-Fib trials never showed superiority for these new drugs, they were approved simply as "non-inferior" and thorough analysis of the trial results revealed that the supposedly good results (just see their advertising/marketing for specifics) were as much due to a poorly controlled Coumadin control group as anything else.

But anyway, that's way more than my 2 cents worth. Please do update us on what your surgeon specifically is referring to...it's his or her job to know a lot more about these things! :wink2:

 

[clumsydancer]

Wow, great info! Thank you. I meet with my surgeon again May 8th and will ask him which drugs he's referring to and post it here.

 

[Protimenow]

There's been talk about thee drugs for some time. I was told by a sales manager at a meter manufacturer two years ago that there will probably be a replacement for warfarin within 5 years (so, now, within the next three years).

Even if such a drug CAN be made, and can be safely used regardless of diet, and wouldn't cause excessive bleeding for surgeries, etc., and had an effective way to immediately reverse the effects -- it will probably follow the model used by the other drug makers: it may cost up to $8 per daily dose. It may be harder to detect effects (if the effects don't show up as a change in INR), and you probably won't test your INR as often. It may not be much safer than warfarin.

Comparing $8 a day to about a dime a day for warfarin, such a drug might look less beautiful. The amount of money that people might save because they don't have to check their INRs as often sing this drug (okay, maybe $25 a month for weekly testing) will pare in comparison to the cost of the medication.

It would certainly be nice to have a good, safe alternative, but I will be surprised if/when one comes out.

 

[clumsydancer]

Good point Protime. Cost is a huge aspect of any new drug and I would rather stick to the tried and true. Who knows though, maybe an alternative is out there somewhere that can be reliable, low-cost and safe.

 

[dick0236]

Cost of these so called "wonder drugs" is an important consideration. 30-35 years ago, when Coumadin was still protected by patent owned by DuPont Chemicals, the cost of the drug was about $120/mo. and that was a lot of money in the '70s/'80s. If, and when, "big pharma" is able to market such a drug, I imagine the patent holder will price the drug many times the price of generic Warfarin.

 

[Guyswell]

Despite the obvious shortcomings of Coumadin (INR testing and sensitivity to changes in diet or lifestyle), I like the fact that its effects are easily reversible in the ER if I ever show up with a serious bleeding event or need emergency surgery. From what I've read, the anticoagulation effect of the newer drugs is not so easily reversed quickly.

 

[catwoman]

When I was in the hospital after my MVR 10 years ago, my surgeon said that a replacement for warfarin was waiting in the wings.
Well, that was Exanta (AstraZeneca) but it was withdrawn due to liver damage.

My family doctor & I have talked about the so-called promising replacements for warfarin, and I have told him I will stick to warfarin because it's been around the block for 60+ years, we know how it reacts and I home-test. Any new replacement would still come with side effects or drug interactions -- we just won't know about all of those for some time, even with drug trials.