Exanta, new coumadin replacement?

[kevin21]

Have you seen this new Drug before? I haven't been here in a while so forgive me if I am late on this.

I just read it in today's Houston Chronicle.

It states that Exantra is in the final stages before FDA approval.

" It promisses the same benefits of warfarin withous some of the side affects." It says that, "instead of working throught the liver like warfarin, Exantra interferes with a protein, called thrombin (duh) that is needed in clot formation."

"Most people respond to the same dose of the drug without the need for adjustment." I guess this means that since it bypasses the liver, diet and lifestyle changes affect it a lot less than coumadin.

It is made by AstraZeneca.

It also says that "most people seem to tolerate Exantra well, but researchers are still studying whether the medication might be harmful to people with kidney failure."

It doesn't reduce the risks of bleeding. (we knew that, it's an ANTICOAGULANT!!!)

It should require less monitoring. (sorry doc)

The article says that it probably won't fully replace warfarin because warfarin is going to be cheaper...

Well, at least they're working on something for us besides better monitoring equipment....

 

[Georgia]

OH BOY OH BOY OH BOY

OH BOY OH BOY OH BOY

That's what we want to see. But you know, I certainly don't think the doctors make any money monitoring us - at least, mine doesn't. My HMO requires the blood work to be done in labs (doc's office personnel can't draw it), so there's no office visit; I think he checks the results on his own time.

 

[Nancy]

Al Lodwick knows all about this drug, and what stage it is in for various clinical trials.

 

[Guest]

Please look at my website www.warfarinfo.com/ximelagatran.htm

So far they have shown that it is about equal to warfarin for blood clots in the legs. When one drug is tested against another to see if it is superior, the FDA likes to see a 5% or less chance that the results could have happened purely by chance. The trial came up with a 6% chance that it was random. OK, but not real good.

Then they tested it for stroke prevention atrial fibrillation. That study is (or was) presented at the American College of Cardiology meeting today. This test was a non-inferiority test. In other words, they wanted to show that it was no worse than warfarin. It seems that they will find that.

When I last spoke to the product manager last October, they were just starting on the tests with heart valves in sheep. So look for approval for heart valves to be several years away yet.

It does not require monitoring of the INR. However, it will probably be required to have monthly liver function tests, because it seems to be affecting some of the liver enzymes. It will almost surely cost a lot more than generic warfarin.

It will be a breakthrough product, but it will probably be another 5 years or so before it replaces warfarin. There are some other, similar drugs in development but they are probably further away from the market.

 

[LeoLillac]

Exanta % year's away

Exanta % year's away

H I, i heard that it will be 1 or 2 years for people with valves
wow 5 year's that's a while .
I feel sorry for the poor sheep they test it on (bah )
Dara
tricuspid valve replacement feb9th2001
Dr Griepp ( surgeon )
Dr . fuster ( my angel)

 

[EVELYN]

Our cardio mentioned this drug today while we were there. Only once problem they seem to be having. About 6% of the study people have had to come off it because it was causing major liver problems....not yet sure if it's self correcting or not once they come off the drug. Apparently it's one pill in the a.m. and once at night and that's it.......wouldn't that be wonderful!!!!!!

ev

 

[Nancy]

The liver situation is a problem. Joe is on a new medication for his pulmonary hypertension (Tracleer) and one of its side effects is liver damage. So guess what? He HAS to be tested every month to check on liver functions or he doesn't get his refills. So if that's the case with Exanta, then you might as well be on Coumadin and get tested for that once a month and not have the liver risk.

Sounds like a less than even trade-off.

Maybe with time there will be some additional improvements in Exanta, say a version 2 or 3.

 

[joy]

How do they do the liver function tests? I am interested in not having to have venous blood draws. They hurt now. Trying to get a protime machine, but haven't made it very far!

 

[ALCapshaw2]

Joy,

Have you asked your lab to use the SMALLEST needle possible,
or better yet, to use a BUTTERFLY?

The Butterfly is super small but costs more and takes a little longer to collect the sample. OTOH, it is a LOT LESS uncomfortable that a big needle stick!

'AL'

 

[ALCapshaw2]

Question for Al Lodwick re: Exanta -

Would Exanta be a good alternative to Lovenox for patients who need surgery or other invasive medical procedures?

'AL Capshaw'

 

[Guest]

Two years ago was thinking that Exanta might be the end of warfarin, so I expanded my clinic to lipid and diabetes management. The state of the art now is to do a liver function test with a finger stick. We have been doing this for eight months now. The machine is called a Cholestec LDX. It takes about 4 or 5 drops of blood but you can get that from a good finger stick.

We looked into this thoroughly. The only liver function test you need to do to screen is called the ALT. If this gets three times above the upper limit of normal (40 is ULN so about 120) then you can either stop the offending drug and/or do a full liver function panel.

If you ask your doctor (as my wife did today) they will tell you that the fingerstick isn't as accurate (have you heard this before) or that they do not trust just doing the ALT. But when really pressed they will have to admit that they have not read anything about it or asked a pathologist about this lately. Remember that they "have always done it that way" and that they have to justify the expense of the older machines that they still have so they will not want to run just one test that doesn't help pay for their equipment.

My service is no longer called an Anticoagulation Clinic. I am now the director of the Clinical Pharmacy Support Services. In addition to warfarin, we now manage lipids, diabetes, have three-year study going on diabetes prevention and today the Medical Director of the hospital called me to his office and said that the medical staff voted 63% to 37% to have me start writing orders for the dosing of Procrit. (You've seen the TV ad - If you are on chemotherapy and have no energy, ask your doctor about Procrit)

 

[pillarpaul]

Congrats, Al

Congrats, Al

Sounds like a nice promotion, Al, so congratualtions I assume are in order. Next time I go see my friend Jack (your board chair) I'd like to look you up. But since I have this thing called valve replacement surgery next week, it might be awhile.

Paul

 

[Guest]

Hope it goes well. Where are you having it done?

 

[Nancy]

Al-

Procrit has worked wonders on Joe's anemia. He was in excellent range today. He hasn't seen that in a long time. So it's not just for chemotherapy patients. It is the only thing that has kept his anemia under control.

I've been meaning to ask you about something we've seen recently, and that is a pharmacist working directly with the patient as a whole separate specialist. One of my friends was seen by what they called the "medicine doctor", and Joe has also had the direct services of a pharmacist (perhaps a doctor of pharmacy?). These specialists are used in cases where there are multiple medicines.

Maybe this all went on behind the scenes anyway, but recently, they are seeing the patients along with the other specialists.

It was a great relief to know that someone was monitoring the balancing act of a huge list of medications.

The reworking of all of Joe's medications and the addition of several new ones, has, so far, been nothing less than a miracle.

Joy--In Joe's case he has to have the full liver panel. It's a venous draw.

 

[pillarpaul]

Al,

Surgery will be at St. Anthony's Central. Surgeon is Lance Walker and cardio is Michael Ptasnik. Know either one?

Got very discouraged last Sunday. Found out an old friend of mine that I hadn't seen in a few years had the surgery a couple of years ago. She has been unable to regulate well and has had severe bleeding in her knee. She is now one of only about a hundred test cases in an experimental study nationwide to use radiation treatments to somehow stop the bleeding. Leukemia is a possible risk that has indeed happened to some of the patients. She is an incredibly upbeat person who is very very discouraged. She urged me to go pig valve. I know her case is very, very extreme. Ever heard of such a thing? I recommended she come here and post something to that effect but I don't think she's registered yet.

Paul

 

[Guest]

Nancy,

Yes, we have been doing medication reviews informally for years. Now that all pharmacists graduating in the US are getting Doctor of Pharmacy (Pharm D) degrees we have many more and better trained people to do this. Now it is developing into a specialty. Also physicians are being trained with these pharmacists as part of the team, so they are more likely to utilize them. Those of us who have been training pharmacy students for a number of years started asking the faculty, "What did you do that was different?" The students in the new curriculum are so much better trained that, in many cases, they have surpassed the capacity of the old preceptors to teach them very much.

Paul,

No I do not know either doctor. I have heard of Ptasnik but maybe that is just because the name would stick in your mind.

I have seen two cases of hemarthritis (Blood in the knee joint). One man had it just before we opened the clinic and then came to me shortly after that. About two years later it started happening again. His INR was only slightly elevated, when he told me that he could feel the pain starting again. He called his son in the next few days and told him that he could not go through the pain again and killed himself with a shot to the head.

That might be how much pain your friend is in. I can see how anyone with that much pain would recommend against warfarin. However, this is an extremely rare complication. What I know about valve choices would fit in the space between "a-b" so I will not comment on that.