November 18, 2010

Is There A New Coumadin Alternative Better Than Pradaxa?

Posted in Heart Disease in the News, New Heart Studies tagged , , , , , , , , at 2:28 am by keepyourhearthealthy

image by Salvatore Vuono

Pradaxa‘s manufacturer, Boehringer Ingelheim, had hoped to keep the cardiology buzz about their drug in the headlines this week.  Much to their chagrin, Bayer/Johnson & Johnson stole the spotlight with their new Coumadin alternative.

Over the past several days, the American Heart Association has been holding it’s Scientific Sessions for American cardiologists in Chicago.  The spotlight of cardiology news over the past month has been a new drug called Pradaxa (dabigatran).  Pradaxa is an alternative to Coumadin that was just approved by the FDA in October and is already available for special order at pharmacies in most states.  Patients with atrial fibrillation have been waiting 50 years for an option other than Coumadin in terms of stroke prevention.

On the Boehringer Ingelheim website, an article about Pradaxa had mentioned they would be presenting their large trial about Pradaxa at the American Heart Association’s Scientific Sessions in Chicago.  The news spotlight however has been stolen by a new, upcoming Coumadin alternative called Xareltorivaroxaban) which is manufactured by Bayer/Johnson & Johnson.  Xarelto has not yet been approved by the FDA but the phase 3 trials were presented at the Scientific Sessions, giving this potential new drug much more publicity than Pradaxa.  The big trial for Xarelto showed that it works just as well as Coumadin at preventing strokes in people with atrial fibrillation.  However, it will likely take at least a year before it is available as a prescription to patients.

So what is the big deal about this new Coumadin alternative called Xarelto?

  1. Xarelto only needs to be taken once a day whereas Pradaxa is twice a day
  2. Xarelto does not require fingerstick monitoring or dose adjustments (same as Pradaxa)
  3. Xarelto was tested in moderate to high risk patients and resulted in less problems with severe bleeding than Coumadin

Even though Xarelto sounds like a great option for patients who do not want to take Coumadin, we still have to look at the facts.  Right now, Pradaxa is the ONLY alternative to Coumadin that is available and FDA-approved.  Other drugs may be coming in the next few years but a better drug than Coumadin has been needed for more than 50 years!  The biggest problem with Pradaxa now is cost.  Out of pocket it is more than $6 per day and Medicare Part D is not covering it at this point. There’s no way to know when or IF Xarelto will be FDA-approved and how much it will cost.  Let’s just pray that we can work out the barriers of price soon so that everyone with atrial fibrillation can enjoy the benefits of stroke prevention without all the hassle of Coumadin.

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