Putting the brakes on the new anticoagulants

[mycrofft]

http://us.boehringer-ingelheim.com/...ate-fda-breakthrough-therapy-designation.html

However, apparently at this point it's more like yanking on the parking brake. More to follow.

 

[Av8or007]

Love how the company that comes out w/ Dabigatran now comes out w/ a MAb based antidote to its own drug...

And because there is no alternate option in pts w significant bleeding, we will have to pay up. Anyone have any idea why dabigatran even got approved w/o a way to reverse it?

 

[JPINFV]

Love how the company that comes out w/ Dabigatran now comes out w/ a MAb based antidote to its own drug...

And because there is no alternate option in pts w significant bleeding, we will have to pay up. Anyone have any idea why dabigatran even got approved w/o a way to reverse it?

Probably because a way to reverse a drug isn't a requirement for a drug to be approved.

 

[Ewok Jerky]

Anyone have any idea why dabigatran even got approved w/o a way to reverse it?

It might be because Dabigatran is probably better at preventing stroke and more importantly reducing mortality, while maintaining the same risk of major bleeding as warfarin. It is actually recommended over warfarin for a certain population of patients. Don't forget there are many drawbacks to warfarin therapy.

Hopefully now that a reversal agent is available physicians will be more comfortable making the switch.

 

[mycrofft]

The medicine? Oh, it is not much.
The antidote? Welllll, that ees another matter……
++++++++++++++

AND I QUOTE "... it offers an alternative to warfarin as the preferred orally administered anticoagulant ("blood thinner") since it does not require frequent blood tests for international normalized ratio (INR) monitoring while offering similar results in terms of efficacy.".

It's better because it doesn't require frequent tests? The lab told me there is no test for the medicine per se, that's why no tests. How about "It's better because it has fewer side effects and does a better job than it predecessors"? Nope.

 

[mycrofft]

Probably because a way to reverse a drug isn't a requirement for a drug to be approved.

Remind anyone of another seemingly successful scientific experiment that "went public" without an antidote ?

 

[STXmedic]

Love how the company that comes out w/ Dabigatran now comes out w/ a MAb based antidote to its own drug...

And because there is no alternate option in pts w significant bleeding, we will have to pay up. Anyone have any idea why dabigatran even got approved w/o a way to reverse it?

So it sounds like you're complaining that a company created a reversal for its own drug, and complaining that they didn't create a reversal when they originally got it approved... So either way, they're wrong?

 

[Av8or007]

Not really. We did need a reversal agent for dabi, so they're definitely good for figuring something out.

Just unfortunate that the price will likely be exorbitant (its a MAb based drug) as this is needed in every hospital.
Vit k is cheap, this one not so much...

 

[jwk]

The medicine? Oh, it is not much.
The antidote? Welllll, that ees another matter……
++++++++++++++

AND I QUOTE "... it offers an alternative to warfarin as the preferred orally administered anticoagulant ("blood thinner") since it does not require frequent blood tests for international normalized ratio (INR) monitoring while offering similar results in terms of efficacy.".

It's better because it doesn't require frequent tests? The lab told me there is no test for the medicine per se, that's why no tests. How about "It's better because it has fewer side effects and does a better job than it predecessors"? Nope.

You understand that warfarin is an absolute ***** to get dosed correctly, right? That's why frequent coag studies are needed. There is no other drug that I'm aware of that requires so much effort to titrate a correct dose - e.g. Monday and Thursday, with a half a tab every other Saturday yada yada yada. This is also frequently an elderly population that may have some cognitive barriers to getting their dose correct - "Honey, did I take my white pill today?" That's why we see some of these patients come in with INR's of 15 and a head bleed.

 

[mycrofft]

I went through the Warfarin two-step twice before cardioversions, it delayed my first one by three weeks.
The 15 INR with a stroke is a nightmare and a caution to anyone ordering warfarin off the cuff.