A New Blood Thinning Drug is Approved – Pradaxa – better than Coumadin?

This post was authored by Sharon Stabile and posted to The Eye Opener on October 22nd, 2010.

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This week’s press release by the US division of the German based Boehringer Ingelheim pharmaceutical company is certainly a breakthrough for patients. The company announced the FDA approval of their drug Pradaxa (dabigatran etexilate). This is the first new oral anticoagulation drug approved in the US in more than 50 years.The drug was approved for stroke and systemic embolism prevention in people who have atrial fibrillation not caused by a failing/defective heart valve.

The press release touts impressive results. National studies have shown when Pradaxa 150mg was taken twice daily, there was a 35% reduction in stroke and embolism when compared with the traditional drug known to most as Coumadin (Warfarin). In addition, at the same dosing level both types of stroke (embolic/clot and hemorrhagic/bleeding) were greatly reduced when compared to Coumadin. More good news for patients taking the drug…

  • Very few drug interactions,
  • No more dietary restrictions, and
  • No more routine blood testing and dosing changes as required when taking Coumadin.

WHAT IS ATRIAL FIBRILLATION AND WHY DO YOU NEED TO TAKE BLOOD THINNING DRUGS?

Atrial fibrillation is a heart rhythm disorder caused by a malfunctioning electrical conduction system within the heart – see video.  It is usually identified by an irregular rapid heart rate that begins in the upper heart.The smaller 2 upper heart chambers, known as the atria, begin to contract quickly and in an irregular fashion. As electrical signals leave the atria and enter the 2 lower heart chambers known as the ventricles, they too begin to contract quickly and in an irregular fashion.  This irregular and rapid heart rate is unable to pump the blood through the heart and out to the body in a strong, efficient manner. Thus blood can pool in the heart and the lower extremities allowing clots to form. These clots dislodge and travel to the heart, lungs, and brain leading to a stroke. Therefore it is important to prevent the clots from forming by correcting the abnormal heart rhythm,  and by lowering the blood’s ability to form dangerous clots.

The press release noted an estimated 2.3 million Americans have atrial fibrillation and the number is expected to increase to 5.6 million by 2050. A large US-based managed care organization used their data to show 95% of all persons with atrial fibrillation have no heart valve problems. Atrial fibrillation increased the risk of stroke 5 times, and is an underlying condition in 15% of all US strokes. Atrial fibrillation related strokes are twice as likely to be fatal or severely disabling when compared to strokes from other causes.

MedicineNet.com today reported recent studies by the New England Journal of Medicine and the American Heart Association found Pradaxa was also more effective in preventing clots in patients experiencing acute coronary syndrome. Sweden reports the drug can be safely used in conjunction with Plavix and Aspirin drug therapies.

WHAT ARE THE DOWNSIDES?

With the good news, comes the drug’s downside. The company is forthcoming in reporting Pradaxa when administered in 150mg doses results in a higher rate of gastrointestinal bleeding related complications when compared to Coumadin. This dose was reported to also cause an increase in adverse GI reactions such as dyspepsia, abdominal and gastric pain, GERD, esophagitis, gastritis, and ulcer. Importantly, in patients older than 75 years of age, the risk of bleeding complications may be greater than Coumadin. Also noteworthy is the finding that the risk of myocardial infarction was greater in studies with patients taking the 150mg dose than those taking Coumadin.

The company warns patients taking other blood thinners, non-steroidal anti-inflammatory medicines, St. John’s Wort, and any drug that can cause abnormal bleeding reactions need to be avoided. Over the counter medications are included in this warning. The company’s public package leaflet notes the drug will interact with Amiodarone and Verapamil and Pradaxa dosing will need to be reduced. The drug may also affect the liver but not more then Coumadin. It is contraindicated in patients who are in kidney failure, liver failure, and pregnancy. Some report a Quinidine interaction.

The FDA has approved dosing in capsule forms of 75mg and 150mg twice a day. Those persons taking larger doses of 150mg need to be fully informed of the above possible complications before switching from Coumadin to an easier life with Pradaxa.

EASIER TO LIVE WITH, BUT WHAT WILL IT COST?

It will take 3 to 6 months before distribution begins and pricing is not known. As with any new drug introduced in the US, speculation is the cost will be just short of prohibitive. Canada Pharmacies online sell Pradaxa 60 capsules both 75mg and 150mg doses at approximately $350.00 each. Generic Coumadin 100 pills at variable doses sell for approximately $34.00 to $50.00. The high drug price for US patients may offset the life style improvements for many who pay out of pocket for drugs. It is not known if prescription drug plans will approve partial or full payment for the drug.

It is generally reported that Coumadin is not a popular drug. Consumers and physicians alike resound with the same low opinion of the drug.  It is a difficult drug for physicians to manage, and it has a great impact on quality of life for patients. If Pradaxa continues to show its improved lifestyle value with no hidden serious side effects, patients will be the winners. Hopefully over time competitors will surface and prices will be driven into an affordable range for the growing US atrial fibrillation patient population.

UPDATE: Interesting piece by Dr. Wes on Pradaxa just posted today. Thought you may want to read. The comments have been coming in fast and furious on this new “wonder drug.”  Here’s the post by Dr. Wes – Pradaxa, Your Days are Numbered

Related Post:

Follow-Up Blog: Important Questions and Answers on Pradaxa

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63 Responses to “A New Blood Thinning Drug is Approved – Pradaxa – better than Coumadin?”

  1. HELEN A HALLNo Gravatar says:

    Please read my comment.
    Thank you

  2. my wife was going to try this new drug as requested by her dr. we have good insurence but still the price was outrageous it will not be affordable for everyday hard working people. please advise about special offers.. would be very nice if my wife could stop going to have her levels checked all the time. you should try to make it a more affordable option for people. thanks for listening Daniel Karlson

  3. please notify me with a response

  4. ArnoldNo Gravatar says:

    I am still concerned as to how one knows if the Pradaxa is working. The conclusion seems to be a statistical conclusion, i.e., if you do not have a stroke or heart attack, it is working. For example, if the control group has 3 such events out of 1000 and Coumadin has 4 out of 1000, the conclusion is that the Pradaxa is working and that it is working better than Coumadin. However, there does not seem to be any empirical based data that the Praxada is thinning the blood and is actually preventing a stroke or cardian event. Of course, there is a test that the coumadin is thinning the blood and, hopefully, preventing storke and cv events.

  5. FrankNo Gravatar says:

    Daniel, have you checked out the ” do at home” blood level testing. Medicare or most insurance companys pay for it. I do it weekly at home, simple, and save running to the lab.

  6. tom parisiNo Gravatar says:

    my wife has a-fib, acquired a stent recently and now must b on plavix and pradaxa. how much more of a risk of bleeding is there, would dropping pradaxa to .75 reduce the risk somewhat? she is also on 1 baby aspirin a day.

  7. Without giving medical advice, Tom, that is a dangerous combination of drugs to anticoagulate someone. Most cardiologists use Aspirin and Plavix, or Coumadin, or Pradaxa. Does the facility/hospital have a Doctor of Pharmacy (it should)? If so, you might want to make a call and ask to speak with the Pharmacologist to ask questions about the bleeding risk associated with this regimen, if it’s an acceptable combination, etc. Get a professional opinion. You can also call your local pharmacy and ask for the doctor/pharmacologist on duty to ask these same questions. Make both calls to see if they corroborate. The information may be very helpful.

    Theresa

  8. Ralf TNo Gravatar says:

    If you have not yet heard, Pradaxa’s manufacturer has acknowledged that there have now been 260 deaths attributable to Pradaxa. I called my cardiologist asking for his agreement to discontinue this med and got it much to my relief. If you want confirmation, just do a Google search for Pradaxa deaths

  9. PhilipBNo Gravatar says:

    Cost – My cardiologist has given me a card provided by Pradaxa’s manufacturer which limits the co-pay to $30 for a one-month supply. Check with yours, they may have it too.
    Bleeding – I’ve been on it several weeks, and once my body adjusted, I have had no bleeding issues. The first week, I noticed some darker stools, but that is now back to normal. I wonder if we should have a sticker on our driver’s license alerting emergency personnel to the fact we take blood thinners? is there such a thing?
    Thanks

  10. FrankNo Gravatar says:

    There are bracelets, necklaces, cards for your wallet, that can be bought that provide information that you are on blood thinners and a lot of other ailments. Just check on the Net for a variety of places too buy.

  11. I have been using Pradaxa for 3 months. I suffered from heartburn Initially but solved this by taking with food.
    The only change i have noticed is my BGL has been easier to control and have had low readings since starting the program. Great to not have blood tests frequently to control INR and to watch eating green leafed veges.
    So far Pradaxa has been free as part of a trial and this may change this year if it does not make the PBS list.
    The chemist says $130/m. Hopefully, the company will overcome the lack of an antidote in emergencies as the blogs about deaths due to pradaxa are worrying. A step in the right direction IMP.

  12. Ralf TNo Gravatar says:

    Yikes, where do you, Stuart come up with acronyms like BGL and PBS. Even Google was baffled by BGL and PBS as medical terminology? And I really agree with you that there needs to be an antidote for Pradaxa. If there was one, I would still be taking it.

  13. BrandonNo Gravatar says:

    Acronyms are not always the same for eveyrone depending on where they live as well.

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