Pulmonary Embolism Support Group
By far the most common form of pulmonary embolism is a thromboembolism, which occurs when a blood clot, generally a venous thrombus, becomes dislodged from its site of formation and embolizes to the arterial blood supply of one of the lungs. Symptoms may include difficulty breathing, pain during breathing, and more rarely circulatory instability and death.
To step away from a thread where a poster asked a simple question about Xarelto and probably got more than he/she intended. :)
From ClotCare
http://www.clotcare.com/warfarin_vs_new_agents.aspx
Novel Anticoagulants Should not Replace Warfarin; Head-to-Head Trial Needed
Marie Bussey
Henry I. Bussey, Pharm.D.
September, 2012
Three recent publications in Circulation suggest that well-managed warfarin may be superior to novel anticoagulant agents for prevention of thromboembolic events. Existing clinical trials of novel anticoagulants have shown the new agents to be non-inferior or even marginally superior to warfarin, but existing trials have compared the new agents to poorly managed warfarin only.
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http://www.roche.ro/fmfiles/re7139002/DIA/click_2.pdf
Response to Granger and Armaganijan
Jack Ansell, MD
Granger and Armaganijan recite the findings from the large atrial fibrillation trials showing varying degrees of efficacy and safety of new agents compared with warfarin, and state, The limitations of warfarin are well established. That is precisely the point of this debate: The limitations of warfarin are well established, but the limitations of new agents are not.
As an example, investigators assumed that they knew the limitations of ximelagatran, an earlier direct thrombin inhibitor. Liver toxicity occurred in 6% to 10% of patients with long-term, not short-term, therapy, but real-world experience in Europe showed that even short-term therapy was not without its risks of important liver toxicity. The drug has since been shelved.
In the last 4 months, 3 countries (Japan, Australia, and New Zealand) have expressed concern or issued warnings to physicians about an inordinate number of major bleeding episodes occurring in patients with atrial fibrillation treated with a new direct thrombin inhibitor, and the manufacturer has just recently agreed to recommend monitoring of kidney function to patients taking the drug in Europe. It is unknown whether these anecdotal reports represent a rate higher than that seen in the clinical trials, and it will require phase 4 post-marketing studies or registries to help to clarify the situation. Whether or not the consequences of poor drug adherence will result in a higher rate of ischemic stroke remains to be seen, but this is also a concern.
The problems of warfarin therapy leading to suboptimal treatment or underuse are well known, but greater focus on improving warfarin management by more widespread anticoagulation management services and much greater use of patient home monitoring, the latter of which has shown results as good as if not better than the best care provided by an anticoagulation service, are needed.
[Jan. 2012]
From ClotCare
http://www.clotcare.com/warfarin_vs_new_agents.aspx
Novel Anticoagulants Should not Replace Warfarin; Head-to-Head Trial Needed
Marie Bussey
Henry I. Bussey, Pharm.D.
September, 2012
Three recent publications in Circulation suggest that well-managed warfarin may be superior to novel anticoagulant agents for prevention of thromboembolic events. Existing clinical trials of novel anticoagulants have shown the new agents to be non-inferior or even marginally superior to warfarin, but existing trials have compared the new agents to poorly managed warfarin only.
******************************
http://www.roche.ro/fmfiles/re7139002/DIA/click_2.pdf
Response to Granger and Armaganijan
Jack Ansell, MD
Granger and Armaganijan recite the findings from the large atrial fibrillation trials showing varying degrees of efficacy and safety of new agents compared with warfarin, and state, The limitations of warfarin are well established. That is precisely the point of this debate: The limitations of warfarin are well established, but the limitations of new agents are not.
As an example, investigators assumed that they knew the limitations of ximelagatran, an earlier direct thrombin inhibitor. Liver toxicity occurred in 6% to 10% of patients with long-term, not short-term, therapy, but real-world experience in Europe showed that even short-term therapy was not without its risks of important liver toxicity. The drug has since been shelved.
In the last 4 months, 3 countries (Japan, Australia, and New Zealand) have expressed concern or issued warnings to physicians about an inordinate number of major bleeding episodes occurring in patients with atrial fibrillation treated with a new direct thrombin inhibitor, and the manufacturer has just recently agreed to recommend monitoring of kidney function to patients taking the drug in Europe. It is unknown whether these anecdotal reports represent a rate higher than that seen in the clinical trials, and it will require phase 4 post-marketing studies or registries to help to clarify the situation. Whether or not the consequences of poor drug adherence will result in a higher rate of ischemic stroke remains to be seen, but this is also a concern.
The problems of warfarin therapy leading to suboptimal treatment or underuse are well known, but greater focus on improving warfarin management by more widespread anticoagulation management services and much greater use of patient home monitoring, the latter of which has shown results as good as if not better than the best care provided by an anticoagulation service, are needed.
[Jan. 2012]
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Look at what my best friend did with my picture!
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We all have 24 hours in a day. How we spend these hours is important. Watching a little bit of a video about how sitting affects us made me aware of how much sitting and laying down I do. Gonna have to work on that.Your turn. Tell me another truth.
I will say that the science behind Pradaxa specifically is based on another med that was pulled from trials years ago called .
I thought that the phrase 'novel anticoagulants' encompassed ALL the new anticoags. At least that's how it sounded to me. Wouldn't Ansell have said 'with the exception of Xarelto'? I know you can't read Ansell's mind but that phrase was pretty damning as read and that's how most people would read it.
"The particular article cited above was written in a manner that the publisher asked Jack to write a counterpoint regarding the new oral anticoagulants."
I think you mentioned that before and it's still confusing to me why a respected doctor would bow to a publisher's wish; that will follow him around as long as the Internet is with us.
"good alternative to Coumadin for certain patients".
Yes, I've read that in many articles-----and that means people who have trouble staying in range with warfarin----(genetic, inherent or lack of committing to the dietary and other restrictions for Vit K)
As Dr. Ansell commented in his letter---- it will depend on the Phase lV people. That's you and the others on these new anticoags. (grin)
And then there are the Superiority and the Non-Inferiority Trials (NIT). Guess why NITs are becoming more prevalent in these days of fast tracking. Sigh.
Forgive me for my pessimistic view of information derived from a conversation with the manufacturer and employee's of a certain drug.
I'm sure you understand. :)
Np.
For additional information on the pros and cons of the newer anticoagulants, if your interested, Tom referenced a couple of links in this discussion thread in the DVT community:
http://www.dailystrength.org/c/Deep_Vein_Thrombosis_DVT/forum/15330615-pradax-dabigatran
The information in the links are very straightforward.
Here is just one article where the Bayh Dole Act is discussed in a fairly balanced manner. (Many other articles either praise it or condemn it.)
http://www.nature.com/nbt/journal/v24/n3/full/nbt0306-320.html
"Fundamentally, Bayh-Dole shifted the incentive structure that governed the research and development path of federally funded inventions by allowing institutions to own inventions resulting from federally sponsored research and to exclusively license those inventions.
The Act also requires the institution to establish patent policies for its employees, to actively seek patent protection and to encourage the development of their inventions. Beyond these basic requirements, the legislation leaves a great deal of discretion to the institutions.
This flexibility has been both a source of strength for Bayh-Dole and a weakness. Many of the issues that are identified today as negative consequences of Bayh-Dole can be traced to the institutional policies structured to optimize institutional benefits and income, rather than to the Act itself."
Another bit of quoted material:
"Over the past decade, these conflicts have become more difficult to manage because the universities that oversee them juggle conflicts of their own, Sharpe asserts.
The 1984 Bayh-Dole Act, which allows universities to garner profits from federally financed research, opened the door to such commercial alliances. The burgeoning biotechnology industry also has provided the musical accompaniment to the academic-business dance.
The related emergence of academic entrepreneurs and contract research organizations, the increase in unregulated, industry-sponsored research, and the dependence of academia on restricted support, makes universities more vulnerable to exploitation by commercial interests, Sharpe says. "The perils are real. Academic-industry relations can meet, or fail to meet high standards of integrity."
From The Scientist 16[2]:48, Jan. 21, 2002
It always comes down to follow the money, which I do.
I did see this:
"indicates that regular liver-function monitoring may not mitigate the possible risk" ( of Exanta)
Makes me wonder what was different about that drug. As I said, more research later. What's your opinion?
Here's a good example:
Sue Hughes wrote two different articles about a month apart for Heartwire.org
The first one 'reassures' people about Pradaxa in Dec 2012:
http://www.theheart.org/article/1485005.do
The second one written in Jan. 2012 is and warns people about it:
http://www.theheart.org/article/1339775.do
Ms Hughes is not smoking weed nor is she crazy. She's a paid medical journalist just regurgitating information about different drugs etc that she gets from the Internet. She does have some medical experience (pharmacy) so she'll not give out dangerous information. Just regurgitated.
Some people will re-post her articles as if they were the final word in medical science. Not true. Check the fine print, guys.
The first article was Jan 2012 warning about the possible bleeding for patients over the age of 75 and with bad livers that take Pradax/Pradaxa...
The second was Dec 2012, reassuring people about the use of Pradax/Pradaxa...
I read The Heart every day.
Just saying...