M
mbalfour
Anyone do any reading on the new trial drug Exanta? Claims are made that one can take FIXED doses without the need for frequent testing. Interactions that plague Coumadin are virtually absent with Exanta. Comments?
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Ross
Well-known member
Only that it's not being tested for valve patients at this time.
Exanta- Not exactly
Exanta- Not exactly
The researcher are still finding out about this drug and have already determined it has problems: halflife is a couple of hours, unsure about liver damage and others.
Warfarin has a fifty years history. It is a case of the "devil
you know or........".
Exanta- Not exactly
The researcher are still finding out about this drug and have already determined it has problems: halflife is a couple of hours, unsure about liver damage and others.
Warfarin has a fifty years history. It is a case of the "devil
you know or........".
K
Karlynn
It is my understanding that as of this fall, the FDA has significantly postponed the approval of Exanta for several years. Here is also a report on Al's site related to this issue.
http://www.warfarinfo.com/ximelagatran.htm
http://www.warfarinfo.com/ximelagatran.htm
Where you live
Where you live
Well I guess it is a matter of what street you are on. I know when I talked
to Dr. Pettersson, he and his associates had determined that unless the medicine changed they way it worked they woud not using it for valve pts. because of problems with pt. compliance. They(CCF) stated that publically in their newletter- a copy of which I forwarded to Al. Problem is most drs. hate to monitor warfarin and can't wait to be done with it without really understanding the impact of a new drug. I certainly don't want to do "beta
testing" on a new drug when so many drs. won't even take the time to understand the drug that has been the standard for over 50 years. Just ask your dr. if he know of any problems with the new drug, if he doesn't that should be your first clue not to change. Didn't we just go through some problems with the FDA approving drug they had no business doing it! Think about it- it is only your life.
Maybe Al still has the copy and maybe we all should get out more
Where you live
sheylathomas said:
Well I guess it is a matter of what street you are on. I know when I talked
to Dr. Pettersson, he and his associates had determined that unless the medicine changed they way it worked they woud not using it for valve pts. because of problems with pt. compliance. They(CCF) stated that publically in their newletter- a copy of which I forwarded to Al. Problem is most drs. hate to monitor warfarin and can't wait to be done with it without really understanding the impact of a new drug. I certainly don't want to do "beta
testing" on a new drug when so many drs. won't even take the time to understand the drug that has been the standard for over 50 years. Just ask your dr. if he know of any problems with the new drug, if he doesn't that should be your first clue not to change. Didn't we just go through some problems with the FDA approving drug they had no business doing it! Think about it- it is only your life.
Maybe Al still has the copy and maybe we all should get out more
sheylathomas said:
Surgeons seldom monitor anti-coagulation in patients. It's almost always done by a cardiologist, PCP or certified anti-coagulation care provider. A surgeon **may** write the initial scrip for AC therapy, but someone else takes it from there.
Using such a drug-off label for AC in patients with mechanical valves would be unwise. Imagine a doctor defending himself/herself in a liability suit over the death of a VR patient who had been prescribed Exanta off-label.
Twenty years ago, I had a hysterectomy (endometrial hyperplasia & endometriosis). First OB/GYN wanted to remove my appendix in addition. I got a 2nd opinion. That doctor questioned the wisdom of also doing an appendectomy, saying that if something went wrong due to the appendectomy and I sued, he'd lose. After all, his specialty was OB/GYN, not doing appendectomies. He said if I wanted an appendectomy, I should consult a general surgeon or someone else. (And said there was no reason to routinely remove the appendix during a hysterectomy other than to pocket a little additional $$.)
I would apply that line of reasoning to someone who would prescribe Exanta off-label for AC for VR patients -- if it were approved by the FDA for use in the U.S.
H
Herb M
Exanta is a product of the same company that produces Crestor. You may have read about some of the concerns about Crestor. I personally would wait a year or two after it is approved for valve patients before I would consider it.
Based on previous discussions about Exanta, I'm not holding my breath. Who would participate in a human test if you knew that you could be the control group? Would the FDA ever approve Exanta without exhausting tests? Maybe the A-fib experiments/usage could ease concerns over time for valve patients, but that would take a long time in my opinion.
Valve-Viking
Well-known member
Well, the latest new on "Exanta" the industry thinks the FDA are very
careful(read overcareful) due to a mistake done with another drug
affecting the liver. This was "Rezulin" which was approved by the
FDA in -97, but stopped by the FDA in -00 with many complications
and a high mortality rate, both known and unknown.(diabetesmedicine).
So after above "mistake", there is a very cautios approach to any
drug that effects the liver, some would say too cautious given the
advantages of "Exanta".
"Exanta" has this year come to use in 7 European countries. In a few
weeks time the first possible decision for approval for use for a-fib
will be taken by the French FDA. If "Exanta" will be approved for a-fib in
France it will put some extra focuse/pressure on FDA´s non approval.
If approved and "Exanta" has the advantages that AstraZeneca claims
and that the wide studies suggests - together with positive results
from real clincial use, american doctor´s are most likely to want to
use the same drug in the US. The French decision will be looked at
as a very important reference.
There are no official information of "Exanta" being tested or under test
for replacing warfarin when it comes to mechanical valves as yet. There
are instead much of speculation and wishful thinking so far. But it is far
to assume "Exanta" needs to proove itself in the short-term use as for
hip-transplants and other orthopedical surgeries, then a-fib and maybe
later valves. So by the time "Exanta" would be ready for valves, one
can assume there will be a lot of real use statistics available. On the other
hand the largest current usage is for short-term, i.e hip-transplants and
alikes. Any short term use might obviously affect the liver much less
the lifelong use as with mechanical valves.
I will post again after the french decision is known.
/
Martin
careful(read overcareful) due to a mistake done with another drug
affecting the liver. This was "Rezulin" which was approved by the
FDA in -97, but stopped by the FDA in -00 with many complications
and a high mortality rate, both known and unknown.(diabetesmedicine).
So after above "mistake", there is a very cautios approach to any
drug that effects the liver, some would say too cautious given the
advantages of "Exanta".
"Exanta" has this year come to use in 7 European countries. In a few
weeks time the first possible decision for approval for use for a-fib
will be taken by the French FDA. If "Exanta" will be approved for a-fib in
France it will put some extra focuse/pressure on FDA´s non approval.
If approved and "Exanta" has the advantages that AstraZeneca claims
and that the wide studies suggests - together with positive results
from real clincial use, american doctor´s are most likely to want to
use the same drug in the US. The French decision will be looked at
as a very important reference.
There are no official information of "Exanta" being tested or under test
for replacing warfarin when it comes to mechanical valves as yet. There
are instead much of speculation and wishful thinking so far. But it is far
to assume "Exanta" needs to proove itself in the short-term use as for
hip-transplants and other orthopedical surgeries, then a-fib and maybe
later valves. So by the time "Exanta" would be ready for valves, one
can assume there will be a lot of real use statistics available. On the other
hand the largest current usage is for short-term, i.e hip-transplants and
alikes. Any short term use might obviously affect the liver much less
the lifelong use as with mechanical valves.
I will post again after the french decision is known.
/
Martin
There is a thread regarding Exanta that should be considered when discussing it. Al Lodwick testified regarding Exanta before the FDA, in hearings where it was determined not to pursue Exanta for any long-term therapies: http://www.warfarinfo.com/ximelagatran.htm
The thread is: http://www.valvereplacement.com/forums/showthread.php?t=8336
Best wishes,
The thread is: http://www.valvereplacement.com/forums/showthread.php?t=8336
Best wishes,
