February 20, 2011

Cardiologists Get Updated Guidelines With Coumadin Alternatives

Posted in Heart Disease in the News, Uncategorized tagged , , , , , , , , , , at 8:11 pm by keepyourhearthealthy

photo by Ambro

An update to the US atrial fibrillation guidelines posted last week has made Pradaxa an official part of the treatment protocol.

When the American Heart Association and the American College of Cardiology published their new atrial fibrillation guidelines in December, many people were left with more questions than answers.  The updated guidelines did not include the newest drug, Pradaxa, which is the only alternative to Coumadin at this point.  At the time the guidelines were published, the American Heart Association promised they would provide an update to the guidelines to include Pradaxa soon.  As promised, the “update” to the “updated guidelines” is officially out.

What do the guidelines say then about this new Coumadin alternative? The guidelines give Pradaxa one of the highest recommendations possible (called a Class I).  They state specifically that it “is useful as an alternative to warfarin [Coumadin] for the prevention of stroke.”  However, they also say, “patients already taking warfarin [Coumadin] with excellent INR control may have little to gain by switching to dabigatran [Pradaxa].”

These new guidelines provide further assistance to cardiologists and patients who desperately needed an alternative to Coumadin.  Through the support of the American Heart Association and the American College of Cardiology, physicians can now prescribe Pradaxa more comfortably for the patients who have trouble taking Coumadin.

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February 9, 2011

Important New Information For Pradaxa Patients

Posted in Heart Disease in the News, Heart disease tips tagged , , , , , , , , , , at 1:04 pm by keepyourhearthealthy

photo from Pradaxa press release

Patients who receive their Pradaxa in a bottle are under a new advisement this week.

Many heart-savvy people have heard about a unique new drug called Pradaxa.  This ground-breaking drug burst into the pharmaceutical market in record time after gaining FDA approval late last year.  Pradaxa is famously known for being unique given that it is the ONLY alternative to Coumadin (warfarin) in terms of preventing strokes for the atrial fibrillation population.

Undoubtedly, thousands of patients have already made the switch from Coumadin to Pradaxa.  What many of these patients may not realize though is that Pradaxa is unique in another important way.  Pradaxa pills sold in a bottle are considered “expired” after only 30 days. The capsules are easily effected by humidity so the manufacturer recommends using all the medication within 30 days of opening the bottle.

A 30-day expiry is very unusual given that the standard expiry for most medications is 1 year.  Some pharmacists have returned their bottles to the manufacturer and requested blister packs instead.  Blister packs are sold in Europe and keep each pill individually wrapped, thus safe from the humidity.

In case you are a new Pradaxa user, it is important that you wait until the last minute to open the bottle.  You should also avoid having more than one bottle open at a time.  If you tend to store your pills in 2 different locations (ie. one at work and one at home), you’ll need a different routine for Pradaxa. The Pradaxa bottle has a special lid which keeps the drug stable so you should avoid putting the capsules in a different bottle. The safest place for the pills is inside the manufacturer’s bottle and the pills still expire within 30 days of opening.

January 13, 2011

The New Coumadin Alternative…What Do Patients Think About It?

Posted in Heart disease tips, Helpful Heart Links, Uncategorized tagged , , , , , , , , , , at 11:47 am by keepyourhearthealthy

image by Idea go

Pradaxa is certainly ideal when you look at how it compares to Coumadin on paper.

Pradaxa is a breakthrough Coumadin alternative that prevents more strokes than Coumadin, does not require fingerstick monitoring and has almost no major interactions with food or other drugs. It sounds like a dream come true for atrial fibrillation patients everywhere who despise Coumadin!

Now that Pradaxa is readily available to patients, what do they think? Is it the amazing new drug that many have expected it to be?  Some say “yes” and some say “no.”  One Pradaxa user posted their experience with the drug on a Pacemaker Club website online and stated they “love the convenience.” Others on the same website complained that it did not work out for them.

The biggest obstacles for many are just what Pradaxa’s manufacturer expected: price and heartburn.  First, many people have to get over the sticker-shock of paying $40 to $250 per month.  Then there’s the common side effect of heartburn.  20% of patients discontinue Pradaxa because it upsets their stomach.

One patient I spoke to stopped it because the heartburn and nausea were intolerable after a few days of switching to Pradaxa.  She eventually switched back to Coumadin and resumed her routine INR checks.  In my opinion she was more likely to get heartburn on the Pradaxa because she also suffers from a large hiatal hernia (a condition where part of the stomach is squeezed up through the diaphragm) which causes problems with acid reflux.  Pradaxa’s manufacturer has already launched a defensive campaign in order to help patients work through problems related to the drug.  Their website www.pradaxa.com offers a support program which includes a hotline and a savings card.  I personally registered for the support program over 2 weeks ago and have yet to receive a response.  Maybe they have a few kinks to work out?

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January 4, 2011

American Heart Association Does Not Include New Coumadin Alternative in Updated Guidelines

Posted in Heart Disease in the News tagged , , , , , , , at 3:34 pm by keepyourhearthealthy

Support the American Heart Association. I'm Se...

Image by stevegarfield via Flickr

On December 20th the American Heart Association released the newest guidelines for management of atrial fibrillation…but something’s missing!

Despite the fact that American Heart Association president, Dr. Ralph Sacco, has called the new Coumadin alternatives “a great breakthrough,” the newest atrial fibrillation guidelines do not include the new anticoagulants.  Pradaxa was approved in October of 2010 and yet this guideline just released at the end of December does not guide US physicians on how to use it instead of Coumadin.  The American Heart Association reportedly states they will put out an “update” to the new guidelines at some point soon in order to include Pradaxa.  Until then, cardiologists will be relying on the manufacturer’s guidelines or recommendations from other physicians who are familiar with the drug.  It certainly presents for an interesting situation when the most updated guidelines are no help with the one of the biggest advancements in afib for over 50 years!

November 15, 2010

Another New Coumadin Alternative on the Rise

Posted in Uncategorized tagged , , , , , , , at 7:15 pm by keepyourhearthealthy

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Image via Wikipedia

In October the FDA approved the only alternative to Coumadin thus far, Pradaxa (AKA dabigatran).  Another new alternative has just finished a round of trials and may be joining in the famed distinction of being named “Coumadin alternative.”

This latest anticoagulant drug is called Xarelto (AKA rivaroxaban) and it is manufactured by Bayer/Johnson & Johnson.  The trial which has cardiologists buzzing about this new drug is known as ROCKET-AF.  14,000 patients with atrial fibrillation in the ROCKET-AF trial have been tested with either Coumadin or Xarelto and so far the results are promising.  Xarelto has been shown to be just as effective in preventing strokes as Coumadin.  The greatest difference between this new study drug and Coumadin is that Xarelto does not require dose adjustments and monitoring.

However, unlike the newly approved Pradaxa, Xarelto has not yet been shown to work better than Coumadin for preventing strokes.  The other Coumadin alternatives are not even approved yet and it already looks like Pradaxa has an advantage over the competition.  If approved by the FDA soon, Xarelto could still easily compete by setting their prices lower than Pradaxa.  To be honest, any drug that works as well as Coumadin but without all the hassle is bound to be popular!

 

 

November 7, 2010

Tired of Coumadin? Ask Your Doctor About Pradaxa

Posted in Heart Disease in the News tagged , , , , , , at 2:15 am by keepyourhearthealthy

Atrial fibrillation

Image via Wikipedia

Between the fingertsicks, frequent dose changes and interactions with food and drugs, its no wonder people want to throw Coumadin out with the garbage!  Unfortunately, Coumadin has been the best option for preventing stroke in atrial fibrillation for 50 years now.

A new drug called Pradaxa (dabigatran) is now leading the way to ridding the world of Coumadin.  Pradaxa works just as well as Coumadin but does not require frequent bloodwork or changes to doseages.  As of last week, patients all over the US could start taking Pradaxa 150mg twice daily instead of Coumadin.  If you obtain a 90-day supply, the cost is about $250 per month out of pocket or $40 per month with prescription coverage.

Pradaxa has merely opened the gates for a whole new group of anticoagulant drugs.  Other options are on the way, which means more competition and cheaper prices.  For now, Pradaxa has taken the spotlight in this history-changing point of heart care.

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October 20, 2010

Coumadin and Warfarin Alternative Almost Here!!

Posted in Heart Disease in the News, Helpful Heart Links, New Heart Studies tagged , , , , , , , , , , , , at 1:14 am by keepyourhearthealthy

 

 

photo from Boehringer Ingelheim website

 

In September, the FDA voted to approve a new drug called Pradaxa (dabigatran).  Today the FDA has announced Pradaxa is officially cleared for market.

The reason why so many people are buzzing about today’s FDA news is because we are now one step closer to getting rid of Coumadin and warfarin.  Pradaxa helps to prevent stroke in patients with atrial fibrillation similar to Coumadin.  However, Pradaxa does not require frequent blood tests to see if it is working.  Currently, people taking Coumadin or warfarin need a blood test at least every month.  See my previous post about this called Goodbye Coumadin!! Hopefully Soon…

According to the FDA website, Pradaxa will be sold in 2 different dosages, 75mg and 150mg.  Using dosages from previous studies, it appears that most people will be required to take 150mg twice a day.  For some patients with kidney problems, there is also the option of 75mg twice a day.

There is already a website for Pradaxa which has been started by the manufacturer (www.pradaxa.com).  The website includes a patient guide so that everyone can learn more about this new alternative to Coumadin.

See the manufacturers press release for more details:  http://us.boehringer-ingelheim.com/news_events/press_releases/press_release_archive/2010/october_20_2010.html

September 22, 2010

Goodbye Coumadin!! Hopefully Soon…

Posted in Heart Disease in the News, Heart disease tips tagged , , , , , , , , , , , , , at 12:22 am by keepyourhearthealthy

photo by graur razvan ionut

Praise God!  The FDA has unanimously approved an alternative to Coumadin (warfarin) in atrial fibrillation.  The new drug called Pradaxa or dabigatran has been available in Europe and Canada for quite some time now.

Yesterday, the FDA agreed that Pradaxa should become available to patients with atrial fibrillation (afib) here in the US as well.  Pradaxa is an anticoagulant or “blood-thinner” that helps to significantly reduce the risk of stroke in afib.

Patients and cardiologists have been longing for a drug to replace Coumadin for many years.  Coumadin (warfarin) is a very old drug that was used as rat poison originally and then converted to a pill form to prevent strokes in certain heart patients.  Coumadin has significant bleeding risks and needs to be monitored with blood checks every few days to at least once a month. There are a ton of interactions for Coumadin as well which makes it difficult to adequately control the levels in some patients.

The newly-approved Pradaxa does not have as many bleeding risks and does not require frequent monitoring. Essentially it could be the answer to cardiology’s prayers…or will it?  The biggest obstacle to prescribing Pradaxa once it is officially in the pharmacy will be PRICE.  Currently, the pills cost $8 to $12 per day in other countries.  The reason it costs so much is because physicians use Pradaxa for short-term conditions abroad rather than for long-term use like in atrial fibrillation.  Hopefully, the manufacturers will cut the cost dramatically so that a majority of the patients can afford it!