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Squeeky



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Join date : 2010-12-04

PostSubject: Pradaxa   Sun Dec 05, 2010 12:15 am

Hello all. Does anybody here have experience with the new anticoagulant, Pradaxa? Especially anybody with APS?
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dero
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PostSubject: Re: Pradaxa   Sun Dec 05, 2010 11:59 pm

Hi Squeeky and welcome to LADVT(Life After DVT) hope I did not have to do this but...

When you say APS you do mean Antiphospholipid Syndrom ??

Presently Pradaxa in Europe and in the USA Pradax in Canada

On March 18, 2008, the European Medicines Agency granted marketing authorisation for dabigatran for the treatment and prevention of thromboembolic disease.

The National Health Service in Britain has authorised the use of dabigatran for use in preventing blood clots in hip and knee surgery patients. Charities, including the British Heart Foundation, are campaigning for the drug to be widely prescribed in place of warfarin, which has the disadvantage of requiring administration up to a week before a target INR level is reached, and heparin, which is administered intravenously or subcutaneously in its low molecular weight form. Dabigatran will cost the NHS £4.20 per day, which is equivalent to several other anticoagulants, but more than ten times the cost of warfarin. Furthermore, the total cost of warfarin use includes the time and cost of INR monitoring, which is not required with dabigatran.

In Canada, approval came on June 13, 2008 for the prevention of blood clots in patients who have undergone total hip or total knee replacement surgery. Approval for atrial fibrillation patients at risk of stroke came in October 2010.

The United States Food and Drug Administration approved Pradaxa for use on October 19, 2010 for prevention of stroke in patients with non-valvular atrial fibrillation. The approval came after an advisory committee recommended the drug for approval on September 20, 2010although caution is still urged by reviewers.

(taken from http://en.wikipedia.org/wiki/Dabigatran )


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My take on it, I was part of the study(phase 3 of it) that was to prove Dabigatran (Pradaxa, Pradax...) to be equal if not superior to warfarin.

Pros

-No INRs needed
-Not a vitamin K antagonist(meaning greens don't affect it like warfarin)
-No known side effects
-Interact with other drugs

Con

-No known antidote, meaning that it will take 24 to 36 hours for it to get out of your system. (renal way)
If you are involved in a traffic accident and need emergency procedures, it MAY be dangerous.

-The cost, it's a lot more expensive compared to warfarin.


So far, it has NOT been approved by the FDA for the fight against DVT. As for against APS, I could not really answer that.

What are you on presently?


Last edited by dero on Mon Sep 05, 2011 12:27 pm; edited 1 time in total
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Squeeky



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Join date : 2010-12-04

PostSubject: Re: Pradaxa   Mon Dec 06, 2010 6:15 pm

Thanks for your reply, Dero. Yes I did mean Antiphospholipid Syndrome.

Actually I have never had a DVT, my blood clots were in my carotid artery and my brain. But I came here because on another message board I was told that there are people here who participated in the clinical trial of Pradaxa. As we all know, I have to educate myself so that I can educate my doctor.

Currently I am on Warfarin and Plavix, and having lots of INR problems. I don't eat vegetables any more, or anything with Vit K in it, but I cannot stabilize my INR. It has been as high as 7.0. So they took me off Warfarin (Plavix only) and I immediately began having TIAs until I was put back on it. So they took me off Plavix (Warfarin only) with the same result. I know that Warfarin is going to kill me, and I know that I would die without it. I need to know if Pradaxa is a safer alternative for me. Although it has not been approved by the FDA for APS, neither has Warfarin, and drugs are prescribed for off-label purposes all the time. Atrial Fibrillation is a life-long condition, like APS. I don't believe I'm going to live long enough to see Pradaxa approved for APS. I believe I need to ask my doctor whether I can have it now. When considering the risks of doing this, the risks of not doing it must also be considered.

Were you ever told whether you got the Pradaxa or the Warfarin? Do you have a clotting disorder? What can you tell me about your experience? Thank you for your reply and please forgive me for crashing your DVT website when I did not have a DVT.
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dero
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PostSubject: Re: Pradaxa   Tue Dec 07, 2010 11:41 pm

First off, no forgiveness given because it's not needed, as you have said, we need to educate and what better then from other's experience?

I was never told that I was getting Pradaxa, but I knew from the lack of side effects I had when on warfarin,(sleepy, in a fog,cold,moody,forgetful...). It takes warfarin seven days to get out of your system and roughly seven days into the study, all of the above disappeared.
I am DVT Idiopathic, originated in my right calf and extended to my pelvis where lucky for me it jammed, otherwise, it was on it'S way to my lungs (PE).
Until I realised that it (dabigatran) had no antidote, it was a dream drug, then in 2009 I had issues with my gallbladder,I needed to have it removed, but since the surgeon had no idea about this drug and my hematologist was not around(being that it was Xmas eve, when I went into Emergency) I missed out on a window of opportunity and had to wait three months before getting the procedure done(yes the Canadian medical has SOME downfalls).
At that point, I went on Fragmin injections (LMWH) and was taken off anticoags in june of 2009.

You can read my journal, it has some info about the study I was involved in. http://lifeafterdvt.forumotion.com/the-lounge-f1/my-story-t2.htm

Hope this helps...

Denis
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dero
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PostSubject: Re: Pradaxa   Thu Dec 09, 2010 4:03 pm

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Squeeky



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PostSubject: Re: Pradaxa   Fri Jan 28, 2011 3:06 pm

Hi Dero-

Thank you for sharing your experiences. With your help I was able to gather sufficient information to talk my doctor into letting me try Pradaxa. Given the cost of Coumadin plus blood tests, Pradaxa costs me $18 a month more than Coumadin. I have been on it for a week now and like you, my coumadin side effects are gone and so far, no side effects from Pradaxa. Here in the US doctors are often afraid to try anything new for fear of being sued if something goes wrong. But since Pradaxa was proven safer than Coumadin, I was able to overcome that hurdle. Yes, the Canadian system is not perfect, but here in the US I have access to medical care because I can afford to pay for it. If I lose my job because of my condition, which is a real possibility, then I will also lose my health insurance. I will have no access to medical care. In this country people die because they can't afford to go to the doctor. In Canada this would never happen.
Thank you for your interest in helping people. You helped me a lot, and I'm sure you've changed the lives of many people.
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PostSubject: Re: Pradaxa   Mon Feb 07, 2011 3:50 pm

Make sure you read this...
more on Pradaxa
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