Marty
Well-known member
Exanta may be approved for afib in 2004. We valvers may not be far behind!
http://heartdisease.about.com/library/weekly/
aa040703a.htm
http://heartdisease.about.com/library/weekly/
aa040703a.htm
EXANTA coming along
- Thread starter Marty
- Start date
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JimL
Well-known member
Thanks, Marty, for more information on our "dream drug." Is there any information on side effects from this drug, about the effects as it's processed through the liver? Is there any indication that it might have side effects worse than coumadin? I know that I have more questions than answers...
LUVMyBirman
Well-known member
Hi Marty,
Yes, thank you! Sound extremly promising.
Just curious, would any of you all try it upon approval for valves? Not certain myself
Yes, thank you! Sound extremly promising.
Just curious, would any of you all try it upon approval for valves? Not certain myself
Wouldn't it be wonderful?
Wouldn't it be wonderful?
I hope it works as well as it looks like it might. It would be an absolutely wonderful thing for anyone who was able to come off coumadin and not put himself in jeopardy. It was an exciting article to read....thanks Marty.............................Betty
Wouldn't it be wonderful?
I hope it works as well as it looks like it might. It would be an absolutely wonderful thing for anyone who was able to come off coumadin and not put himself in jeopardy. It was an exciting article to read....thanks Marty.............................Betty
Marty
Well-known member
Exanta and the liver
Exanta and the liver
Hi Jim, Gina, Betty, et al., the only thing I have heard about Exanta side effects is that it may have an adverse effect on the liver and that if you are on the drug you will need frequent liver tests, I don't know how frequent. This is something I want to know a lot more about before I go off the rat poison.
Exanta and the liver
Hi Jim, Gina, Betty, et al., the only thing I have heard about Exanta side effects is that it may have an adverse effect on the liver and that if you are on the drug you will need frequent liver tests, I don't know how frequent. This is something I want to know a lot more about before I go off the rat poison.
LUVMyBirman
Well-known member
Then the combination of liver effects with cholesterol lowering medications and Exantra may be an issue? I hear you need liver function tests when taking cholesterol meds. Also, Rain brought to my attention that cholesterol meds can raise your INR when combined with Warfarin. So...Exantra could be a "good thing". Compromising liver function is another story. I always say.... for one fix there is always another price to pay.
Hmmmmm. May be a catch 22 for some. When and if they approve Exantra for valve patients...... it would have to "prove" itself to me over a period of a few years before consideration. We have to remember....just because the FDA approves something does not mean it's 100% safe.
Hmmmmm. May be a catch 22 for some. When and if they approve Exantra for valve patients...... it would have to "prove" itself to me over a period of a few years before consideration. We have to remember....just because the FDA approves something does not mean it's 100% safe.
Johnny Stephens
Well-known member
Having jumped onto a new drug too quickly once before (Redux), I've learned my lesson and would really need to see some dramatically clear advantage before jumping again. I'm of the same mind as Gina, but then I'm luckily very stable in my INR and dosage with warfarin. I realize there are others who are having problems that would really welcome this.
It's great that there will be more options for us all.
It's great that there will be more options for us all.
G
Guest
I was at a meeting of anticoagulation specialists (700 present) this week, so there was a lot of talk about Exanta.
They have set back the date for sending a request for approval to the end of 2003. This would mean that about the earliest it could be approved would be the end of 2004. But in reality 2005 is more likely.
There was no mention of any progress on studies for mechanical valves. So far as anyone knew it is still being tested in sheep and has not been tried in a human with a valve yet. Even though they have a dose for people with clots in the legs, they still have to start with a dose ranging study for people with mechanical valves.
It seems to raise the liver function tests to about 3 times the upper limit of normal around 6 months after you start taking it. So far these seem to go back down to normal if you continue the drug, but this is the big sticking point right now. Few people have taken it for as long as a year.
Many people have taken warfarin for over 20 years and we know there seems to be no long term toxicity, but this will have to be learned with Exanta over the next 20 to 30 years. Many of you will be the ones who lead the way.
BMS (the current owners of the Coumadin brand) have re-started providing education material etc. They also have a new drug being studied that will be similar to Exanta. I think it is at least 2 years behind Exanta in development.
QAS is going to sell several types of meters now, not just the ProTime. There is a lot of competition now and this should start bringing the prices down.
The studies being done on Exanta are called non-inferiority trials. This is something new in the world of drug testing. They handle the people who drop out of the studies in a novel way from past statistical studies. So far they have not been overly successful at showing equivalence. This is probably because clinics that specialize in handling warfarin have done so much better than physicians who handle only a few warfarin patients each. They planned to study Exanta vs warfarin handled by physicians and then studied it against clinics like mine. Our complication rates are so much lower than patients managed by their PCPs or cardiologists (we have only about 1/4 of the serious bleeding incidents of doctors 12 % vs 3%) that they were unable to prove anything beyond "maybe" equivalent.
So there is at least 18 months of wait and see and even longer for valvers.
Stay tuned for further updates.
They have set back the date for sending a request for approval to the end of 2003. This would mean that about the earliest it could be approved would be the end of 2004. But in reality 2005 is more likely.
There was no mention of any progress on studies for mechanical valves. So far as anyone knew it is still being tested in sheep and has not been tried in a human with a valve yet. Even though they have a dose for people with clots in the legs, they still have to start with a dose ranging study for people with mechanical valves.
It seems to raise the liver function tests to about 3 times the upper limit of normal around 6 months after you start taking it. So far these seem to go back down to normal if you continue the drug, but this is the big sticking point right now. Few people have taken it for as long as a year.
Many people have taken warfarin for over 20 years and we know there seems to be no long term toxicity, but this will have to be learned with Exanta over the next 20 to 30 years. Many of you will be the ones who lead the way.
BMS (the current owners of the Coumadin brand) have re-started providing education material etc. They also have a new drug being studied that will be similar to Exanta. I think it is at least 2 years behind Exanta in development.
QAS is going to sell several types of meters now, not just the ProTime. There is a lot of competition now and this should start bringing the prices down.
The studies being done on Exanta are called non-inferiority trials. This is something new in the world of drug testing. They handle the people who drop out of the studies in a novel way from past statistical studies. So far they have not been overly successful at showing equivalence. This is probably because clinics that specialize in handling warfarin have done so much better than physicians who handle only a few warfarin patients each. They planned to study Exanta vs warfarin handled by physicians and then studied it against clinics like mine. Our complication rates are so much lower than patients managed by their PCPs or cardiologists (we have only about 1/4 of the serious bleeding incidents of doctors 12 % vs 3%) that they were unable to prove anything beyond "maybe" equivalent.
So there is at least 18 months of wait and see and even longer for valvers.
Stay tuned for further updates.
Marty
Well-known member
Very interesting, Al. Can't get this kind of information anywhere else. Thanks.
joy
Well-known member
I don't think I would take it, as I have two disorders of my liver already. I will stick to the coumadin. It really isn't as bad as I thought it would be. I thought it would be HORRIBLE! I's two pills once a day, and a needle stick once a week. Not bad. Thanks for the information, though. Medicine has gone a long way, and is only getting better!
T
tnboomer1013
It may do me some good.
It may do me some good.
With the way I work it sounds like a dream for me. In and out of the country, out to places they have to pipe sunshine in. It is just not possible to get to a lab for that wonderful stick every two weeks. 2 pills a day, well that is like nothing more than than taking 2 tylenol for a cold. I myself will welcome anything that takes the place of coumadin.
BOOMER
It may do me some good.
With the way I work it sounds like a dream for me. In and out of the country, out to places they have to pipe sunshine in. It is just not possible to get to a lab for that wonderful stick every two weeks. 2 pills a day, well that is like nothing more than than taking 2 tylenol for a cold. I myself will welcome anything that takes the place of coumadin.
BOOMER
G
Guest
Boomer,
If you had your surgery almost 2 years ago, you should be at least 18 months beyond having to go in to have your INR checked every 2 weeks. Once a month is sufficient for almost everyone.
If you had your surgery almost 2 years ago, you should be at least 18 months beyond having to go in to have your INR checked every 2 weeks. Once a month is sufficient for almost everyone.
T
tnboomer1013
nope
nope
It's an every 2 week thing. Because of my diet and the way I work which I do forget now and again to take it. My inr level usually is all over the place. It has just been a big life style change, something I have yet to master. But I do have a long time to get it right and something I can take without having to get stuck so often would be a God send.
BOOMER
nope
It's an every 2 week thing. Because of my diet and the way I work which I do forget now and again to take it. My inr level usually is all over the place. It has just been a big life style change, something I have yet to master. But I do have a long time to get it right and something I can take without having to get stuck so often would be a God send.
BOOMER
ALCapshaw2
Well-known member
Taking Coumadin EVERY DAY requires discipline.
I started with a chart (data sheet) numbered 1 to 31 for each month listing every medication I take and write either the dose or number of pills taken. After missing a couple of entries, I obtained a 7 day pill box for my Heart Pills which I took just before bed time. After changing some of my medications to mornings, I will obtain another box for the morning pills. This allows me to double check to see if I forgot to take the pills or merely forgot to make my entry on my tracking sheet. Bottom Line: I've only missed two doses of Coumadin in one year and my INR has been quite stable for many months. I also have a ProTime Home Test Unit which I use to check INR between visits to my Coumadin Clinic.
'AL'
I started with a chart (data sheet) numbered 1 to 31 for each month listing every medication I take and write either the dose or number of pills taken. After missing a couple of entries, I obtained a 7 day pill box for my Heart Pills which I took just before bed time. After changing some of my medications to mornings, I will obtain another box for the morning pills. This allows me to double check to see if I forgot to take the pills or merely forgot to make my entry on my tracking sheet. Bottom Line: I've only missed two doses of Coumadin in one year and my INR has been quite stable for many months. I also have a ProTime Home Test Unit which I use to check INR between visits to my Coumadin Clinic.
'AL'
G
Guest
Boomer,
Please go to the missed dose thread and on page 2 read the message from Joe777 and my reply.
If you have to have your INR checked every 2 weeks because of missed doses, you are well on your way to a wrecked valve or a paralyzing stroke. You have to make up your mind whether you want to change your life style to fit with warfarin or change your lifestyle to adjust to only one side of your body moving after your stroke. One of my patients was 17 when she lost the use of her left arm and leg, at 21 she now knows that it will never improve.
It is like the old Fram oil filter commercials where the mechanic said, "Pay me now or pay me later."
Please go to the missed dose thread and on page 2 read the message from Joe777 and my reply.
If you have to have your INR checked every 2 weeks because of missed doses, you are well on your way to a wrecked valve or a paralyzing stroke. You have to make up your mind whether you want to change your life style to fit with warfarin or change your lifestyle to adjust to only one side of your body moving after your stroke. One of my patients was 17 when she lost the use of her left arm and leg, at 21 she now knows that it will never improve.
It is like the old Fram oil filter commercials where the mechanic said, "Pay me now or pay me later."
Nancy
Well-known member
I think there is an awful lot of time discussing how hard it is to maintain Coumadin and many tend to forget why it is that Coumadin has to be taken.
For mechanical heart patients, it is given to prevent clot formation on the mechanical valve. It is a very, very necessary medication, as Al has said many times, your life could be ruined by forgetting to take your Coumadin, the flip side of the coin is that if you do not get regular testing, your INR could get dangerously high or dangerously low.
Make this the most important pill of your day if you have a mechanical valve. Your heart valve will not do well without this protection, even for one day.
For mechanical heart patients, it is given to prevent clot formation on the mechanical valve. It is a very, very necessary medication, as Al has said many times, your life could be ruined by forgetting to take your Coumadin, the flip side of the coin is that if you do not get regular testing, your INR could get dangerously high or dangerously low.
Make this the most important pill of your day if you have a mechanical valve. Your heart valve will not do well without this protection, even for one day.
JimL
Well-known member
I think of my mechanical valve as the poison, and coumadin as the antidote; I take my antidote faithfully every day.
G
Guest
I never thought of it that way, but very well put.
I saw my youngest patient today - age 5. She had her valve replacefment at 5 months. She was complaining because her older sister gets to start T-Ball but her doctor said that he was afraid that she might get hit in the chest with a bat and not to play. I told her that she needs to learn to read very well and make herself very smart. That way she could grow up to own the baseball team and all of the players would have to do what she told them to do. Boy did her face light up at the thought of being her big sister's boss!
She also offered me part of her ABC gum. Mom said, "Remember it is the thought that counts."
My oldest patient age 107 just passed away. You can read about her and see her picture at http://www.chieftain.com/display/tuesday/news/articles/ni9.htm
Note that her caregiver was an 87 year-old daughter who drove her to the clinic each month.
I saw my youngest patient today - age 5. She had her valve replacefment at 5 months. She was complaining because her older sister gets to start T-Ball but her doctor said that he was afraid that she might get hit in the chest with a bat and not to play. I told her that she needs to learn to read very well and make herself very smart. That way she could grow up to own the baseball team and all of the players would have to do what she told them to do. Boy did her face light up at the thought of being her big sister's boss!
She also offered me part of her ABC gum. Mom said, "Remember it is the thought that counts."
My oldest patient age 107 just passed away. You can read about her and see her picture at http://www.chieftain.com/display/tuesday/news/articles/ni9.htm
Note that her caregiver was an 87 year-old daughter who drove her to the clinic each month.
Hi Boomer
Hi Boomer
I'm sure you wear a watch..Buy one that has an alarm to ring at 6 p.m... Keep your Warfarin with you..Briefcase, ect. when you travel.. When I travel..I tell my family..don't forget to remind me of my medicine....Spent the night with my son last night and told him..don't forget to tell Mama to take her medicine.( Had a lot going on)..this morning he said..did you take your medicine last night. LOL.. I said, Yes.. but at least he remembered.. Get your family and friends involved.. As for as diet..don't go overboard on the greens..( I am a Southern too and we do love our veggies. Bonnie
Hi Boomer
I'm sure you wear a watch..Buy one that has an alarm to ring at 6 p.m...
Keep your Warfarin with you..Briefcase, ect. when you travel.. When I travel..I tell my family..don't forget to remind me of my medicine....Spent the night with my son last night and told him..don't forget to tell Mama to take her medicine.( Had a lot going on)..this morning he said..did you take your medicine last night. LOL.. I said, Yes.. but at least he remembered.. Get your family and friends involved.. As for as diet..don't go overboard on the greens..( I am a Southern too and we do love our veggies. Bonnie
