Anyone heard of Exanta?

[Bryan B]

Hi,

I'm a newbie here who's about to have a VSD repair and AVR at age 43 (just got over a bout of IE that tipped the scales). I like the idea of the durability of the mechanical valve but not the lifetime of anticoagulants (and all that comes with it). My surgeon recommends the St. Jude mechanical valve and mentioned that a new generation of anticoagulants with much fewer side effects are on the not too distant horizen. I did some research and found a few articles about Exanta, which is manufactured by AstraZeneca and is in clinical trials. With this drug there will be no need to monitor INR and no diet restrictions (it sounds too good to be true!!!) I was wondering if anyone has heard about this drug and do you know if it will it be approved for use in valve replacement anticoagulant therapy.

If this drug is only a year or two away from being available I would choose the mechanical valve without hesitation. I have a lot of decisions to make in the next few weeks...grrr!

 

[JimL]

Welcome Bryan! There has indeed been much discussion of Exanta. If you use the search function, you can find many references. You might also want to check out http://www.warfarinfo.com/ximelagatran.htm, which I think has a special article on Exanta.

Fixed Link-Ross

Exanta, if I remember correctly, is being tested in other areas first, and we mechanical valve people will get our chance later. Some are hesitant to switch from coumadin until there is a lot of clinical testing on other people first. One person said, I want to be the 1,000,000th person to try Exanta.

In case you haven't heard you, coumadin is no big deal. The most difficult part of coumadin is all the out-of-date information about coumadin. For example, you don't need to restrict your diet so much as to keep it consistent. Put differently, you need to keep the amount of Vitamin K in your diet consistent. If you eat a big spinach salad one day a month, you will have problems; if you have a spinach salad every day, no problems, except that your coumadin dosage will be higher.

Again, welcome, and read lots of posts.

 

[ccrawford]

Hi Bryan - For what its worth, my cardio feels very confident that the drug will be approved for valve transplant patients. I echo Jim's comments about Coumadin being a no issue, and I have eight months experience with my St Jude mechanical. Chris

 

[Karlynn]

Hi and welcome,
In my humble opinion, Coumadin (warfarin) gets a lot of bad press and there are still a lot of doctors (and dentists) that really are not up on the latest information on it. As I said in a post yesterday, it is a serious drug to be used with knowledge and understanding, as just about all drugs taken by someone with a heart issue.

I had my mitral valve replaced 12 years ago with a St. Jude mechanical. I was 32. So for 12 years living life with Coumadin has been no big deal. (It's been much easier dealing with taking Coumadin, than dealing with teenage children!) I just followed the guide lines, tested my INR at least 1 time a month and it's not been a life altering issue for me.

I will look forward to a "safer" anticoagulant. But I'm going to make sure it's well tested for "valvers" before I give it a try. Right now I'm having a hard time grasping taking an anticoagulant that you don't have to blood test.

Best Wishes

 

[Jan]

Welcome

Welcome

Hi Bryan

Welome,

All of us here can understand your concerns,

read as much as you can and I am sure you will make the right decision for YOU

Warfarin ( coumadin ) is not as bad as it sounds if the correct procedures are taken, consistancy is the key

Good luck with your decisions

Jan

 

[Bryan B]

Thanks for the responses. I have worked in and around hospital pharmacies for 15 years and have some understanding of anticoagulation therapy. One of my concerns (that I just thought of today) is that I travel extensively, and many of our clients are in "remote" locations where dining options are limited and hotels with refrigerators and microwaves are not always available to store and prepare groceries. I realize that I won't be traveling anytime soon after surgery, but I'm a little worried that once I get back to my normal duties I may not be able to consistantly regulate my diet while I'm on the road. But I'm guessing where there's a will there's a way. Any road warriors out there who have any experience with keeping their INR levels in range while away from home for extended periods? I have had stretches where I have traveled for as many as 8 straight weeks, only home on weekends.

 

[Ross]

Yeap we got a few road warriors here too. Give them time to swing through and answer. I'm finding that diet isn't that big of a deal, at least for me. I haven't eaten anything consistently and I manage to stay within range. The other thing you may want to check into is home testing. That way, you'll be able to test on the road and make adjustments accordingly. It's not an option for everyone, but if insurance will cover it and a Doctor writes a prescription for a home test unit, it's definately the way to go.

 

[fdegranville]

coumadin and travel

coumadin and travel

Hi Bryan,
I have been on Coumadin for the last six month due to A fib. I do have valve disease, but have not had my valves replaced yet (still in the waiting room). I also do a heck of a lot of traveling with my job. Soon after starting on Coumadin I traveled everywhere in the world from New York all the way to Guam with every stop in between. In the beginning my numbers were low and I had to be checked frequently which turned out to be the biggest pain in the neck when I was out of state. I made sure that between trips overseas when I was gone for more than two weeks at a time, I would be checked here before leaving. Eating on the road is not too much of a problem. As was mentioned earlier, eat as consistently as possible and learn the foods that afffect INR. For the last 4 months my INR has been within range.

If you do travel a lot you may want to invest in a testing machine as Ross recommended. As you can see, there are numerous threads discussing the pro's and con's. Anoher tip, if you don't have one already, wear a medic alert bracelet and carry a detailed medical info sheet in your wallet in case of accidents while traveling.

Hope this helps,
happy travels,
fdeg

 

[Guest]

One popular misconception about Exanta is that it will be a safer drug. So far this has not proven to be true. Bleeding occurs at the same rate (maybe even slightly higher) than with warfarin. There is also something happening with possible liver damage, but it hasn't been worked out yet. So far the liver enzymes have reverted back to normal. The only real improvement is that it does not need to be monitored. The press reports are ignoring the bleeding rates.

I became involved with this drug in late 2000. To date, there has been no study reported in the literature of even an animal study where the animals had mechanical valves. An animal study has supposedly been in the works for over 18 months but nothing has been reported.

One of the members here has been taking warfarin off-and-on for 43 years. The off was when they did not know much about mechanical valves - like whether you needed warfarin forever or not.

Do not base your decision on which valve based on Exanta. It is still too iffy (mechanical valve wise for that.)

One way around fluctuating diets is to take a vitamin that contains vitamin K every day. This will provide a constant source of vitamin K and dietary variations will not mean much. Besides the cost and necessity to take the vitamins along on trips is the possible drawback that you will have to take a higher daily dose of warfarin. The does is not really very important but it could be a psychological factor.

 

[JimChicago]

Al writes:
>>>>
One way around fluctuating diets is to take a vitamin that contains vitamin K every day. This will provide a constant source of vitamin K and dietary variations will not mean much. Besides the cost and necessity to take the vitamins along on trips is the possible drawback that you will have to take a higher daily dose of warfarin. The does is not really very important but it could be a psychological factor.
>>>>

That is one thing I was wondering about. I know when I first got out of the hospital I could barely eat anything - then I was in range on about 10 mg per week - if I then drank say an 'Ensure' it would wreak havoc wit my INR.

However if I were taking a vitamin supplement that had 50 mcg of vitamin k each and every day (or ate a green salad every day etc) and was stabilized on coumadin for that level of intake - then if my diet intake fluctuated like +/-20 mcg the result would be minimized, since percenatge wise then fluctuation is less in this case.

I would be afraid to take vitamins with k in them but wonder if that makes sense?

 

[Guest]

I know a hematologist who uses this technique on almost all patients. The result is that she has few patients who take less than 10 mg of warfarin daily. She says that it makes fluctuations in the INR almost nonexistant. The hard part is convincing people to do it. They worry about the warfarin dose. However, the dose is irrelevant - only the INR matters.

 

[ccrawford]

Al - Doesn't the liver have to work harder to metabolize the larger doses ? Chris

 

[Guest]

Whether or not the liver works harder is almost immaterial. The liver is like a freight train when all you need is a bicycle.

Alcohol and Tylenol are much harder on the liver. Look how long people have to abuse alcohol before they get liver disease.

I don't know how much that doctor uses but I think that it is just a regular, generic vitamin tablet. It may not matter much. I don't advocate this for everyone, but I could see it for someone who travels to underdeveloped countries and has an iffy food supply.

 

[Valve-Viking]

Hi Bryan!

I also got my mechanical valve due to bacterial endocardities.
I am very much looking forward to a possible breakthrough
by Exanta. As I am quite young contracting this disease, I
would love the idea of not having to monitor my INR for the
rest of my life, also to avoid food interactions of course.
As far as I understood even the interaction of alcohol is
much less, even though hardcore drinking is not on the
agenda for me, it would be nice not to count every glass
once in a while and on special occasions.

But what I hear from doctor´s here in Sweden(where Exanta
are being developed), is that there are still many tests to be done when it comes to the use for mechanical heartvalves, as far as I understood they have put some heartvalves in sheeps as yet
which they are testing the drug on.

Exanta has been approved for limited use(hip-transplants etc)
in France at the end of last of year and there are many other
countries just pending for approval(limited use so far).

The downside could be that the effect is has to your liver might
complicate things. But so far the few percents that were effected
got their values back to normal after some time. But I agree one
have to be very careful with new medicines and it´s better to
be a bit skeptical then too hopeful. Then there are several results
from comparing warfarin with Exanta, some good some bad, but
the overall effect seem to be that Exanta causes less bleeding-
occasions and less consequences following that. But time will proove it I guess.

If Exanta wins approval here in Sweden, I won´t hesitate to
start using it as our standards are extremely high(probably same in the US) and I think the days of drug-scandals are gone, there are too much serious pre-research and "checkpoints".

Living with warfarin has been o.k with me, tonight I am even
going downhill skiing, with my valve and pacemaker, I wear a
good skihelmet and try to take it as easy as possible. Of
course accidents can and do occure, but I try to be as careful
as possible without setting too many limits to my lifestyle.
I know other people on warfarin that would avoid above, but
everyone has to find their own "risk-management" and see how
much it interacts with your normal/prefered lifestyle.


As far as travel is concerned, I just came home from Thailand,
checked the INR twice there in a small local hospital(Island of
Koh Samui). After x-mas I went down a lot in my INR, think it
was the Swedish x-mas food with too much of cabbage. But
this was still under control. In my profession I normallly travel
to Lithuania, Moldova, Portugal, Germany, U.K, Spain, Russia, China, India, Taiwan, Thailand, Vietnam, Tunisia, Singapore,
Indonesia + a few other countries, all in a typical year. I intend to go on like this, but taking it easy without stress. As far as INR-
testing is concerned I hope to start with Coaguchek soon.

With above intense travelling, exposure to different food,
different time-zones, possible risk of an upset stomach etc,
of course I am much more interested in Exanta then a senior
citizen eating pork-chops every monday, talking a walk every
wednesday etc, i.e same routines all the time. For me it is harder
to keep the INR-ratio that even, but normally it´s inbetween
2.6 and 3.1(target 2.1 - 3.0 here in Sweden for aortic valve).

So let´s see what will happen, meanwhile I am just amazed
how well you can feel after all!

Sorry not to keep above shorter, if I get started I am hard to
stop!

Take care you all and greetings from a cold Sweden!

 

[Guest]

This is a good summary of Exanta and an example of how well a person can function with warfarin even uder rigouous travel conditions.

It raises one point that I hadn't thought of earlier, however. With Exanta's effect on liver enzymes, I wonder if it will have a stricter prohibition against alcohol than warfarin.

The major improvement of Exanta over warfarin is that everyone can take the same dose and monitoring is not necessary.

I do not think that it has shown less bleeding than warfarin. I think it was a little more, but not enough to be statistically significant.

One of the major problems with alcohol and warfarin is the possibility of alcohol-caused irritation of the GI tract getting bleeding started and warfarin making it continue.

My guess is that one of the trade-offs for Exanta is going to be that alcohol consumption will be a little more risky both short-term and long-term than with warfarin.

High standards for approval are not a predictor of long-term outcomes. There is a person on this website who has had warfarin 43 years. His outcomes have been more related to lack of warfarin rather than the effects of taking it.

 

[Harpoon]

Echoing what everyone else said on the "difficulty" of coumadin maintenance...


I got my valve in March of 2003 (10 months ago now) and I've only had ONE "problem" where the INR was out of range and that was most likely caused by going off one of the medications I was on. I skipped the dose that was due the evening I got the results on the INR/PT and the dose the next night (I take 8mg at night before dinner) then two days at 4mg and two days at the 8mg then another blood test, which was normal.

You may bruise more easily than you're used to, a cut might take longer to clot, and may even soak through a band-aid if it's deep enough, but that's it.

I watch what I'm eating (I do that anyways for sodium content) and only dip into the "forbidden fruits" once in a while, usually foregoing another vitamin K rich food I eat more often.

Everyone's body is different in regards to how they process vitamin K and their coumadin and their clotting factors so it's important to find what's best for YOU. You do that by making sure you get your PT/INR on a regular basis and just keep in mind what you're eating and how often.

SOmeone mentioned recently a concern about having veggies that are staples in their diet go out of season and how that might affect levels. It probably would depending on the vegetable and if you substituted it for canned or frozen varieties, so all you do is bump up the frequency of your bloodwork when your diet changes and maybe adjust your dosage accordingly.


It's just a matter of balancing the "chemistry" in your system and keeping it in balance through regular monitoring and making adjustments when neccesary.