Update on Exanta - "The Future Coumadin Replacement"

[RobThatsMe]

Hi Gang,

Well, let's hope that this drug proves itself and really does replace Coumadin within the next few years!

Here is a link to an article I read this morning.

http://apnews.excite.com/article/20031030/D7UG6K980.html

Happy Fall to All!

Rob

 

[McCln]

Rob

Rob

I heard on my local news related to the network announced that exanta would be available soon. I certainly hope so and hope that articificial valve people can use it also. I will keep my eyes out on the news also. Thanks for sharing and take care.

Cqroline
09-13-01
Aortic valve replacement
St. Jude's valve

 

[bvdr]

Thanks Rob,

I've been following the development of Exanta with vested interest. Thanks for the update.

 

[Christina]

Heard this morning on our local news that the FDA will give their approval for this new medication by X-mas. Exciting news, to say the least.
My husband thinks that with this new blood thinner coming on the market, we cannot do hometesting. I say it won't make any difference, and we should be able to do the testing ourselves.
What do you think?

 

[RobThatsMe]

Hi Christina,

Great question.... Perhaps Al may shed some light on this.

Thanks,
Rob

 

[tommy]

The New England Journal of Medicine article hit the Paul Harvey news today. That's big time exposure. Frankly, I am hopeful but skeptical as to the timing.

Pesky testing will be greatly reduced. Drug and food reactions will be greatly reduced.

Approval may come in stages. I have not seen heart valves specifically refered to. With the critical nature of dosage, we may be the last to be approved. Rob may have it right - a few years.

Overall, it sound promising. I'm just not ready to raise the victory flag as fast as Tom declares supremacy by the Marlins (Boys of October).

 

[DickV]

It is good news. I will follow it closely and plan to be the 1,000,000th user. I want to make sure the first 999,999 (many of which may be you guys) survive the stuff.

Many of the early deaths with the current style of mechanical valves were not the actual valves but rather the trial and error in dealing with the medication/coagulation issues.

 

[Johnny Stephens]

What Dickv said

What Dickv said

I too hope that eventually, this drug proves to be of benefit to valvers. I don't believe they would do a blanket approval for all possible conditions - rather on a condition - specific basis as data comes in.

Thanks for the post, Rob!

 

[Georgia]

The article I read didn't address the issue of lifelong use; and I'm certainly concerned. If I were only anticipating using it for 6 months or so I'd jump right in. But after recent FDA fiascos, I'll wait a few years until there's some long term research.

 

[Guest]

Re-read the article closely. It was about clots in the legs and preventing clots after knee surgery. It said nothing about heart valves. It also said that they were hoping to apply by the end of the year, not that it would be available by Christmas. Sorry to dampen your hopes but this drug is several years away from proving itself effective in mechanical heart valves.

 

[Marty]

Liver problems

Liver problems

Recent NEJM Grand Rounds on an Afib patient brought up possibility of liver problems with long term use of Exanta. It will take years to establish whether this drug is suitable for patients with mechanical heart valves.

 

[Guest]

So far, the longest anyone has taken Exanta (in a published article) is about 18 months.

One of the VR members has been on it (off and on) for 43 years as of today.

That is a tremendous difference is our long-term safety knowledge.

 

[Christina]

Post for Al Lodwick

Post for Al Lodwick

Hi Al,

I'd like to know the VR.com member who is on Exanta, so we can pick his brain. )
The following question was already put to the forum members, but you might not have seen it?
Will we still be able to hometest while taking Exanta? My husband says we can't, but I say we can and that it is all about how quickly the blood coagulates. It's not about the medicine.
Who is right?

 

[KristyW]

Clarification

Clarification

Christina,

I think what Al meant was that Exanta is new and we won't know how long it will be before approved for long term use, HOWEVER warfarin/Coumadin has been in use for almost 50 years...including one of our own members who has been on it appx. 46 years.

As for the home testing, my understanding was that there wouldn't be any need for it as there isn't the dosing adjustment needed with Exanta that there is with warfarin/Coumadin. Once the level is found, testing would only be needed a few times a year to make sure the coagulation was sufficient. However, liver function testing once a month might be a reality.

HTH

 

[Guest]

Thanks Kristy, I wasn't very clear.

I've heard someone knowledgeable in the field say that you could test the INR with Exanta. But, I'm not sure. There would be little reason to do so since there will be only one dose marketed. I think that it will be marketed as a coated tablet that cannot be broken. Therefore, you would have three choices - take none, take the same dose, double the dose. So testing will be essentially meaningless. No matter what the result you will have to still keep taking the same dose. Can you imagine getting your insurance company to pay for that test??

 

[catwoman]

Al:
When I read the article on Exanta, I had a lot of questions. Some because I have a mechanical valve, some because I've been a newspaper copy editor for 25+ years.
Like you, I noticed that the study did not include heart valve patients, or at least mechanical valve patients.
When this drug is OK'd in the U.S. by the FDA, won't it be fairly pricey, since there won't be another of its kind? Would insurance companies be willing to pay for it when there is a much cheaper drug available (warfarin) even factoring in monitoring costs?
Would Exanta's mfr have to go through another, lengthy study to show efficacy & safeness in heart valve patients before it could be approved for long-term use in those patients? What is the procedure for doing those tests? Does the FDA require written notice from a US pharmaceutical company before trials of a drug for a specific use?
TIA for your thoughts.

 

[Guest]

We don't know what the price will be yet - probably more than warfarin.

Insurance will eventually pay - at first who knows

They are doing studies on mechanical heart valves now.

The only way that we will know for sure about long-term effects is when lots of people take it for a long time.

 

[LUVMyBirman]

Hi Al,

Studies on mechanical valves taking place overseas? If you come across information....please inform.

Thanks

 

[Guest]

I haven't heard anything for about one year about the valve tests. At that time they were just starting on sheep.

 

[Guest]

One of my students just updated my page on Exanta. You can see it at http://www.warfarinfo.com/ximelagatran.htm