Dabigatran (Pradaxa) interesting article on who, when, how to switch

[Lynlw]

Since Pradaxa is available today in the US and Canada, There is an article Q&A type thing with one of the principle Investigators of the trials for Afib. One good thing is it is about 1/2 the proce they were expecting (but sitll high for a med you need 2 times a day forever IMO) http://www.theheart.org/article/1142899.do
New York, NY - Dabigatran (Pradaxa, Boehringer Ingelheim) will be available in both Canadian and US pharmacies as of today for its newly approved indication: to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, the manufacturer, Boehringer Ingelheim, has announced [1]. The company has also said the drug will be priced at a "wholesale-acquisition" cost of $6.75 per day, lower than expected based on the up to $12/day price in markets where it is already approved for limited duration use after hip and knee surgery.

Physicians who've waited decades for an alternative to warfarin now have a host of questions about how to use the drug and in whom. heartwire put some of these to Dr Michael Ezekowitz (Lankenau Institute for Medical Research, Wynnewood, PA), co-principal investigator on the pivotal RE-LY trial. more at link

 

[Bob in Colorado]

This is very interesting. If I read it right though, it was NOT approved for patients with mechanical heart valves.

 

[Lynlw]

This is very interesting. If I read it right though, it was NOT approved for patients with mechanical heart valves.

Correct, it was just approved for Afib

 

[Bob in Colorado]

Thanks Lyn. I've been on warfarin with home testing for just a year. Things are going well, but it sounds like this would be an improvement in medical management when it is available for mechanical valve patients.

 

[catwoman]

Boehringer Ingelheim has started running some TV commercials about a-fib. Commercial doesn't give name of any product or the pharm mfr, but does provide a website. I checked it out last night -- www.afibstroke.com, I think -- and at the bottom it lists Boehringer Ingelheim. Website doesn't give name of any Rx.

 

[Rosebud54]

My surgeon told me last Monday that the medical community believes it will be approved within a year or two for people with Mechanical Valves.

 

[Greg a]

Thanks Lyn and Marsha

 

[Lynlw]

My surgeon told me last Monday that the medical community believes it will be approved within a year or two for people with Mechanical Valves.

As far as I know they haven't even started any trials for Pradax and people with mechcanical valves, so thats kind of hard to imagine, knowing how slow things take to be approved.
Altho there are alot of things going on right now, with new drugs, percutaneous valves etc. that making valve decisions in a couple years might be different than things people take into consideration now.
.

 

[Julian]

I would guess that if plavix gets approved for the On-X valve how much different would pradaxa be as far as being approved. It would seem that almost all new afib only drugs would work with On-X after plavix approval right?

 

[Luana]

There's one slight thing about PRADAXA that concerns me: "PRADAXA can cause bleeding which can be serious and sometimes lead to death." This is from their Web site, and I believe also mentioned in the TV commercials.

Since there is no test to determine any kind of safe or unsafe range with this drug, why would anyone want to take it?

 

[GordoAVR]

There are a couple of FDA trials involving anticoagulants like Pradaxa ongoing concurrently. IMO all anticoagulants are going to incur some level of bleeding risks... that is what makes them work against clotting.

 

[Luana]

There are a couple of FDA trials involving anticoagulants like Pradaxa ongoing concurrently. IMO all anticoagulants are going to incur some level of bleeding risks... that is what makes them work against clotting.

Yes, and the huge advantage with Coumadin is that a test can tell if you are or are not in range. With no test, how would one know?

 

[Jkm7]

There's one slight thing about PRADAXA that concerns me: "PRADAXA can cause bleeding which can be serious and sometimes lead to death." This is from their Web site, and I believe also mentioned in the TV commercials.

Since there is no test to determine any kind of safe or unsafe range with this drug, why would anyone want to take it?

There is no 'antidote' to plavix and that is widely used.
If I were to develop a-fib, I absolutely would prefer taking pradaxa to coumadin. That would be my choice but understand it would not be everyone's. I was thrilled to end the short course of coumadin I had post op my tissue valve.

Yes, and the huge advantage with Coumadin is that a test can tell if you are or are not in range. With no test, how would one know?

It is set dosage, not ranges like coumadin. Same as there are set dosages of most of the medications we take, doctors determine which dose they want for their patients. Same as some patients take 50 mg of toprol xl (for example), others take more or less.