Drug to replace Coumadin?

[Granbonny]

I've heard through the grapevine several times, reading this forum and others on Warfarin, that there is a drug in the not far future to replace Coumadin..Forget the name Anyone know the real lowdown on this..know Al said he would be in Reno this week, but maybe he can fill us in..Bonnie

 

[RobThatsMe]

Hi,

The name of the drug under testing is "Exanta"

I had some sites bookmarked for more information, but looks like they have changed the sites. Here is one that will provide some more detail.

I am sure there are others if you do a search, but I am at work now and don't have much time to look for you.


http://www.pharmj.com/Editorial/20010804/news/rd_anticoagulant.html



Rob

 

[Marty]

? Exanta

? Exanta

I talked to the Astra-Zeneca detail man at Inova today. He says the day they are ready to market Exanta is a big secret but he thinks a year or ...two. The salesmen wil be the last to know because the company does not trust them to keep a secret.

 

[Zipper]

Marty...would you be comfortable being among the first to use the Exanta when it finally surfaces???? Hmm...while it sounds great, I think I'd wait and see. I guess I'm always a skeptic til something is widely used effectively. Thanks for the info..that's funny(lol) that they don't trust their salespeople!

Thanks,

Zip *~*

 

[Granbonny]

Call me Micky

Call me Micky

or Minnie..I'll be glad to be a rat.. Bonnie

 

[wlaldridge]

I am with Bonnie,


I don't like what I hear about the instability of warfarin.

I see that they have applied for a license to sell Exacta in Europe for preventing strokes in cases of A-fib.

It sure seems like a better way to go.

 

[Icarus]

Exanta - What Astra-Zeneca said

Exanta - What Astra-Zeneca said

Hi Bonnie,
I posted a note in "New Advancements" about Exanta about a year ago. Since then I've been watching it like a hawk, - I would like to get off Coumadin and it's really annoying Vit. K side effects. I just e-Mailed them recently and got the following reply;

==============================================


Thank you for contacting AstraZeneca LP regarding EXANTA(tm) (ximelagatran)

In response to your inquiry, the EXANTA(tm) is currently an investigational
agent and has not been approved by the Food and Drug Administration.
Limited information is available and the actual availability date is not yet
known. As to your question on the use of EXANTA(tm) in patients with
"Mechanical Valves" this is not one of the indications that is currently
being studed for EXANTA(tm).

If we can further assist you, please contact the Information Center at
AstraZeneca at 1-800-236-9933, Monday through Friday, 8 a.m. to 7 p.m. ET,
excluding holidays.

============================================
I wasn't thrilled with the notation that it's not for mechanical valves, but that could only be a disclaimer on their part and can be prescribed by a Cardiologist for Mitral/Aortic anticoagulation. Don't know yet. It was developed for Deep Vein Thrombosis as an anti-clot drug. If it's anti-clot, why not use it as a total Coumadin replacement????

Icarus

 

[LUVMyBirman]

There is another drug out there called Plavix that is a platelet inhibitor and is not used solely for anticoagulation in prosthetic valve patients. I have heard Coumadin and Plavix being used in combination for such patients that may be having TIA's with a therapeutic INR. It just keeps the platelets from sticking together. I would keep a real close eye on my INR if taking both meds.

Anway, thanks for posing the information on Exantra. Though, it does not sound too promising. AL Lodwick our pharmiscit/Coumadin expert may be interested in this post. He mentioned that he will be posting more information on Exantra. Should be interesting to see what he comes up with.

 

[Marty]

Exanta Guinea Pig?

Exanta Guinea Pig?

Zipper,the answer to your question is yes. I would love to be in the first group of mechanical valvers to test Exanta. When I first heard the paper delivered in DC two years ago I was delighted.It is a "direct thrombin inhibitor" i.e. it goes right to the heart of the clotting cascade eliminating worries about Vit K, etc. etc. However I really didn't realize how long it takes to get a new drug on the market these days.. Actually there has been no testing to date on valve patients. I'm beginning to think it is years away for us though I believe they will be using it for deep vein thrombosis, in A-fib, after orthopedic surgery, and possibly in some other related areas soon. With the present INR guidelines and self testing and self management warfarin is working pretty well for now in us valvers. I think they are afraid to rock our boat. Recently two woman had valve trouble on Lovenox and it was panic time..Lets wait to hear what Al digs up!

 

[Granbonny]

Dr. Marty

Dr. Marty

One of the ect., ect., ect., about taking warfarin is going from a 3.5 to a 2.0 in a week's testing because I had a Flu shot Bonnie

 

[Johnny Stephens]

This is just me, but after jumping too quickly onto the Redux bandwagon, I'll be a little more wary if/when this gets approved for valvers. Just my comfort level, and others will have their own feelings about it.

Hey Bonnie, I thought the flu shot makes your INR go UP?? I thought I saw that in another thread, but maybe I'm wrong.

 

[Kim]

Bonnie,

I, too thought the other posts indicated an increase in the INR. I am scheduled to get mine on 11/15, but may not if it causes a decrease in the INR. I would much rather be high than low.

Anybody else had their flu shot and can share their experience with their INR?

 

[Marty]

Bonny,find your dose!

Bonny,find your dose!

Bonny, you need to find your dose. This should be the weekly total mg that gets you at say INR 3.0 to 3.5 in a week of average activity ,average diet, average martini ,etc, etc. Then having found this dose. don't test too often because that danged INR fluctuates like crazy. From some of your posts I think you may have found your dose already or close to it. Then when you test...every 3 or 4 weeks, use the 10% solution if you are out of your desired range. Reduce weekly dose 10% distributed as close as you can get it over 7 days. For example lets say your weekly dose is 35mg and you wish to stay about INR 3.2. You test and get 3.9. Lower your weekly dose 10% to 31 mgms. You could get close to this with 4mg tabs Mon,Wed, Th,,Sat, Sun, and 5mgm Tues and Fri. You would need to stock pills of different strength. My weekly dose is @19mgm and I stock 2.5's and 3's. If I go 3 weeks at 19.5 or 20 I know my INR will creep up. If I take 18 or 18.5 it will drift down slowly.Give this scheme a try. A lot of us around here have made it work. When my wife went into Afib last year her card told me to regulate her and he was surprised that she tested so steadily at 3.0. Alas my buddy is no longer popping coumadin with me .They shocked her into sinus rythym and then stopped her rat poison.

 

[Ross]

There is another drug out there called Plavix that is a platelet inhibitor and is not used solely for anticoagulation in prosthetic valve patients. I have heard Coumadin and Plavix being used in combination for such patients that may be having TIA's with a therapeutic INR. It just keeps the platelets from sticking together. I would keep a real close eye on my INR if taking both meds.

I am one of these people. I'm on 75mg Plavix once a day, 81mg Aspirin once a day, and it looks to be 7.5mg Warfarin and 10mg. I don't really know yet. Still unstable. Last test yesterday 5.5. No dose until PT is taken again Friday. I think the sweet spot is going to be in that range though.

 

[Guest]

Sorry, that I have not written more lately but I have had so many requests for my consulting business that it took all of my spare time and more during Oct.

The weekend before last, I had dinner with the product manager for Exanta, in Albuquerque. While the drug is going to probably be on the market in 2004, it is probably going to only be approved for atrial fibrillation at that time.

An article was published in Annals of Internal Medicine during Oct about its use in preventing blood clots in people who had hip replacement surgery. Statistically, it was found that it was equal to warfarin in effectiveness and bleeding complications. There was a 7% chance that the results were due to pure luck. The FDA requires that the odds of pure luck be less than 5%, so right now it is being looked on as only as good as warfarin for hip replacement.

If there was good news for valvers, I would have written this sooner but unfortunately there is not. They are only now beginning to do studies on sheep with simulated heart valves. It will be a long time before these are completed and analyzed. Then they have to do Phase I - dose finding studies on just a few, maybe a dozen people with valves. Then they do Phase II - safety studies on maybe a hundred people. When this is analyzed, then they go to phase III - safety and efficacy studies on maybe 1,000 people.

My guess is that they are at least 5 years away from having FDA approval for mechanical heart valves. So tend to discount stories that you might see in the press because they are going to be for people taking Exanta for different reasons.

In fact, they are going for approval for treating blood clots in France but they are using an injectable form of Exanta (instead of Lovenox) along with the oral form. I do not think that they are even trying the injectable form in the US, so what you see from France is not going to be very applicable to the US.

There is always the possibility that another company will have a competing product hiding in the bushes, but AstraZeneca is pretty confident that they are the closest to market.

 

[Granbonny]

Thanks Marty

Thanks Marty

Clinical nurse wants me to do a 5 mg. on Sundays now..Will take my first one this Sunday and test about 3 days later. You are right. Hubby gets mad because I test to often...Now I will be on 35 mg. a week and will used your formula....Drank those v-8's too. Never again. Johnny..I was guessing it was the flu shot. Don't know Bonnie

 

[Guest]

What I have found about the flu shot is about 3 days after the shot the INR goes up to about 5. But it only stays there about a day or 2 before it drops back to the normal range. So I almost never adjust a dose if the INR is high in this time frame after a flu shot because it will then be low when you test again the next time.

Many people will tell you that nothing happens after a flu shot but I think that this is because they have not had the opportunity to test as many people as I have. I only see it in less than 1% of the people because they do not come in during the small window of opportunity.

 

[Marty]

Exanta, flu shot

Exanta, flu shot

Al, thanks for the detailed latest news on Exanta. Its sort of what I expected. Exanta is years and years away for valvers. I tested 3 days after my flu shot and was in range. It mustn't effect every body. Bonnie I think you are close to carefree coumadin dose and more infrequent testing. Keep us all informed of your progress. It is educational for all of us. Most of us don't have somebody like Al checking our dosage. In my 4 year experience those who do it themselves are less likely to get in trouble with anticoagulation.

 

[Guest]

Here is something truly amazing, I think. I asked the guy who is the product manager for Exanta if he would send the pharmacy student training with me the 15-slide Power Point presentation he gave in Albuquerque last week. He said that he would. Instead he sent her 90 Power Point slides! She is going to give a 20-minute talk to our hospital staff, but he just made her one of the world's authorities about Exanta with all of the test data that he sent her. The only stuff he said that he did not include are results of studies that are scheduled to be announced at various medical meetings in the next few months. I can't say enough about how up-front AstraZeneca has been about this.

 

[lcwhitney]

rat poison replacement

rat poison replacement

I don't know about anyone else but I would love to have something that could replace coumadin. I am really tired of having people ask me if I know that warfarin is rat poison.