The Old and the New: Warfarin and Dabigatran February 4, 2010
Posted by John D. Day, MD, FHRS in Atrial Fibrillation (AF).Tags: AF, Atrial fibrillation, Blood thinners, Coumadin, dabigatran, Warfarin
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Is there anything better than Coumadin (warfarin) to prevent the atrial fibrillation strokes?
I cannot think of a medicine that is more detested by patients, nurses, and physicians than Coumadin (warfarin). I wish I had a dollar for every time a patient tells me “I don’t want to take ‘rat poison’.”
Yes, this medication has been used in rat poison. The rats are given a massive dose of the drug which causes internal bleeding. However, in humans if the medicine is properly monitored and dosed it can be life-saving by preventing most of the strokes caused by atrial fibrillation.
For the last 50 years we have not had any better oral blood thinners than Coumadin (warfarin). Fortunately, this will hopefully change in 2010!
This year we expect FDA approval of a new blood thinner, dabigatran, for atrial fibrillation. Dabigatran is one of several new blood thinners that we hope will soon be approved.
In a large clinical trial, dabigatran was shown to be as good at preventing strokes as Coumadin (warfarin). The clear advantage of dabigatran is that it does not require frequent monitoring and there are not all of the food interactions, so patients can again eat their “green leafy vegetables.” The only downside I can see at this point is that it will definitely cost much more than Coumadin (warfarin).
Heart Rhythm Society
Laurie Racenet, RN, MSN, ANP
Michael Giudici, MD, FACC, FACP, FHRS
Heather M. Ross, DNP, ANP-BC, CCDS, CEPS, FHRS
Anne Dubin, MD, FHRS
John D. Day, MD, FHRS
Andrea M. Russo, MD, FACC, FHRS
Joshua M. Cooper, MD, FACC
Amit J. Shanker, MD, FHRS, FACC
Bruce Stambler, MD
David Wiggins, RN, BS BME, CEPS
Fred M. Kusumoto, MD, FHRS
Leonard Ganz, MD, FHRS
christinechiuman
Craig Delaughter, MD, PhD
Ariana Del Negro, Heart Rhythm 2010 Quality
Peng-Sheng Chen, MD, FHRS
MSKremers MD,FHRS
Ann C. Garlitski, MD, FACC, FHRS
Alan Cheng, MD, FHRS
Ulrika Birgersdotter-Green, MD
Christopher Clyne, MD, FHRS
Kathleen Blake, MD, MPH, FHRS
David Scher, MD, FHRS
Sanjay Deshpande, MD, FHRS
When will the file with the FDA
Interestingly rats are now resistant to warfarin. Clearly warfarin has had its day!
At this time, neither the FDA nor Boehringer Ingelheim (manufacturer of Dabigatran) have released an expected approval date for this medication. Phase III of testing was completed successfully late last year and we anticipate that an announcement will be made in 2010.
I have read about the use of Dabigatran in knee and hip replacement surgeries and for heart rhythm issues to help prevent strokes. I have a St. Jude Mitral Valve — can it be used instead of Coumadin in this case?
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Kennesha Baldwin, Heart Rhythm Society Staff
What is the estimated date for FDA approval?? Early this year??
Now it looks like it will not be approved until early 2011.
Are they palnning on conducting ACS trials, if so when?
Could my husband get into a trial study of Dabigatran? Also, when might it be available in the US?
Thank you,
Linda Valk
Unfortunately, you did not published my comments about unexplainable waiting for approval by FDA of Dabigatran for another 18 months after three years of successful clinical Trial,as political incorrect. If any Agency, even the untouchable Federal agency, has refused to give any reasonable arguments, why is waiting so long for approval, any suspitions came to anybody of dozens of millions of American patiens, who are waiting so long. The silent Ignorance by FDA is not the best answer.
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will it be approved for use in patients with DVT history and Factor V Leiden ( no atrial fibrillation)?
I am a retired md at high risk of developing atril fibrillation soon. I wish urgently that dagigatran be available to me when that time comes!!!
In light of the apparent excellent data on Dabigatran, can physicians consider having their patients acquire the drug from overseas or Canada and supervise its administration? what are the legal reamifications of this?
The website theheart.org (free registration required) reported that the FDA’s Cardiovascular and Renal Drugs Advisory Committee will discuss dabigatran on September 17, 2010: http://www.theheart.org/article/1086745.do
The Committee has posted its meeting announcement regarding dabigatran: it will be held September 20, more information at http://www.fda.gov/AdvisoryCommittees/Calendar/ucm224194.htm
i am willing to take chance with dabigatran for my mechanical valve. the risks with warfarin are too great. i dont think doctors can really control warfarin, altho they think they can.anyone else feel this way ?
There are also drawbacks of dabigatran: twice daily dosing, increase in dyspepsia and GI bleeds as compared with warfarin, more patients in trials discontinued dabigatran than warfarin, renally cleared, and there is no reversal agent when a bleed does occur.
The FDA has approved dabigatran to prevent stroke in those with atrial fibrillation, http://ow.ly/2WKg1
is dabigatran used for prevention of stroke in heart valve replacement patients?
I had my mitral valve replaced in 2009.I am going to need my aortic valve replaced also and currently use coumadin. However when I had the surgery I was not made aware of the side effects or the problems associated with the drug.Is this new drug approved for mechanical valve replacement?
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