Simpler Blood Thinner Found Effective for DVT

[JimChicago]

From:
http://www.medicalnewstoday.com/medicalnews.php?newsid=19962
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Simpler Blood Thinning Medication Found Effective for Preventing Recurrent Blood Clots
13 Feb 2005

A medication that could simplify anticoagulation therapy, ximelagatran, was found to be as effective as other common therapies for preventing stroke and recurrent blood clots, according to studies in the February 9 issue of JAMA. Ximelagatran is currently approved for use in some European countries but it has not been approved in the United States because of concerns about adverse effects.
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?In conclusion, for the initial and prolonged treatment of deep vein thrombosis, direct thrombin inhibition with oral ximelagatran, 36 mg. twice daily, was as effective as enoxaparin/warfarin, without the need for coagulation monitoring or dose adjustment. The mechanism and clinical importance of the increased liver enzyme levels in ximelagatran-treated patients requires further evaluation. Prospective assessment of coronary events in future studies is warranted,? the authors write.
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[Guest]

Further studies might be warranted, but my guess is that the drug will not be marketed in the US. I don't think that there will be much time left on the patent and AZ won't be able to recoup much on its investment. There is an unpublished study that these people writing articles about Exanta are ignoring or don't know about. It is called SPORTIF IV. This is the one that had the fatal liver failure case and proved that there is no way to reverse this drug once someone starts bleeding and no way to predict who this is going to happen to. Until you see the results of SPORTIF IV published, ignore everything else that is written about Exanta. The FDA has the results but they haven't gotten into a medical journal. They were widely discussed at the Sep 10, 2004 FDA meeting at which I testified.

 

[JimChicago]

I giess the pharmaceutical company hasn't given up yet. But wonders why should one run a risk of fatal liver problems etc when warfarin is a safer alternative.

From:
http://www.delawareonline.com/newsjournal/business/2005/02/09medicaljournale.html
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Medical journal endorses Exanta
FDA rejected AstraZeneca stroke drug after concerns raised about liver damage
By RICHARD SINE / The News Journal
02/09/2005An editorial in the country's largest-circulation medical journal said federal regulators may have erred in rejecting AstraZeneca's stroke drug Exanta.

"People in my specialty have been following this drug for a number of years," said Dr. Victor Gurewich, a Boston-based vascular disease specialist and author of the editorial appearing today in the Journal of the American Medical Association. "We were, without many exceptions, all hoping it would be on the market soon because we see a great need for it."
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[Guest]

Delaware has lots of AZ employees, so they have been watching it closely. Richard Sine interviewed me back in Sep at the FDA meeting. I think my opinions made as far as the delete key!