More press on exanta

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Simon can you copy and paste the article? We have to become members just to view the article and I'm not sure how many people are willing to do that. :(


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Ross,
It's either something to do with it being a UK site, or maybe the site was playing up when you clicked on the link. I had to refresh twice before I got to it. Anyway, as it's lunchtime and I'm at a loose end, here's the article all nicely cut and pasted :) .

"The drug to make you clot-free
by Dr Thomas Stuttaford


A YEAR OR TWO ago I attended a local party to celebrate the marriage of the faraway son of an old colleague. The occasion was marred by a problem afflicting my old friend. He had had a haemorrhagic stroke, a bleed into the brain, as a result of drinking more at the wedding than he should have done.
It was not that he had been other than his usual decorous self but he had one or two drinks more than his usual ration. Acceptable behaviour in the other guests, but he was taking Warfarin as an anticoagulant.



Doctors often suffer from the misapprehension that the normal rules of pathology and pharmacology don’t apply to them. Like many older people, the bridegroom’s father suffered from atrial fibrillation. This is an irregular heart rhythm that is a common cause of ischaemic strokes, those caused by a blood clot settling in and blocking one of the arteries in the brain.

To prevent this happening, patients who are fibrillating should, if there are no contra-indications, always have anti-coagulant therapy, often Warfarin. If using Warfarin, they must be careful not to take more than is needed. If they do, they risk a haemorrhagic stroke, a stroke caused by bleeding. If they take too little Warfarin, they may suffer the more common type of stroke, that resulting from a clot.

Until recently, the gold standard for anti-coagulation has been Warfarin, which has held sway for 50 years. Warfarin is a very effective anti-coagulant but it is not easy to find the correct dose. It needs regular time-consuming monitoring and careful dose adjustment. Every aspect of the patient’s lifestyle should be regular. The dose needed can be affected by minor changes in the diet.

The best menu is akin to the monotonous one served at an old-fashioned boarding school. The amount of alcohol taken is also all important; it has to be exactly the same whether it is being drunk when there is something to be celebrated or it is a wet Sunday at home.

All other medication prescribed has to be reviewed in the light of the anti-coagulation and the effect of any drug metabolised in the liver along the P450 pathway must be assessed. All in all, Warfarin is lifesaving but also lifestyle restricting. Get the dose wrong and the penalty may be a haemorrhage, as with the film director Michael Winner, who ended up in hospital with a severe nose bleed, or my former colleague who suffered a cerebral haemorrhage.

In the latest edition of Nature Reviews there is an account of the story of the development of Exanta (ximelagatran). Exanta is an oral anti-coagulant that is likely to replace Warfarin as the standard care for the many patients who need regular anticoagulant therapy whether because of such conditions as a cardiac arrhythmia (including atrial fibrillation), valvular heart surgery or a history of any disease which might lead to thrombovenous embolism.

The advantages of Exanta are not only that it is taken by mouth, but it is much more easy to control the coagulation monitoring. Exanta does not require the same time-consuming frequency of attendance at anti-coagulation clinics. Maintaining a normal lifestyle, even enjoying a family wedding without worrying about the champagne, becomes possible with Exanta because it reacts only to a small extent with other common medicines, different types of food or alcohol.

Exanta has a half-life of four or five hours but retains sufficient anti-coagulation activity for 12 hours to prevent clotting. So taking a tablet twice daily gives an adequate dose.

Another surprising advantage is that the same dose is suitable for all adults, irrespective of their body weight, gender and ethnic origin. No wonder that it was described by Dr Gerry Dolan, consultant haematologist at the Queen’s Medical Centre in Nottingham, as an advance that will transform the medical approach to anti-coagulation therapy in the treatment and prevention of conditions leading to thrombosis."





The opinion of warfarin in the 4th and 5th paragraphs are akin to those expressed at our local hospital. I have to say, there seems to be some differences of opinion from diferent sides of the big pond. I'm sure if Jim had believed the above opinion he'd be terrified to do anything. Fortunately, we've learnt a lot from everyone here and know better. He doesn't have to drink alcohol every day if he doesn't want to !!
Simon - it's a very interesting article. Funny how the author doesn't mention that it hasn't been tested for valve replacement patients yet - I bet there are hundreds of people the length and breadth of the country rushing to their doctors this very minute :eek:
Also, you have to take it twice a day instead of once. And didn't Al Lodwick say something about it possibly causing liver damage? Very interesting though. (Oh, I said that already!)
Gemma.
 
He also fails to note that in the trials bleeding complications such as his friend's hemorrhagic stroke occurred at about the same frequency as they do in people taking warfarin.

Everyone seems to be equating no monitoring with no side effects. We are told nothing about what the friend's INR was when he had the hemorrhagic stroke.
 
I have been selected to be one of the people to give an oral presentation on Exanta at the Cardiovascular and Renal Dugs Advisory Panel Public Hearing in Bethesda, Maryland on September 10, 2004. This is one of the steps in the Food and Drug Administration deciding if the drug should be approved and what restrictions, if any, it should have.
 
Hi Al,

It will be very interesting to hear in which way Exanta is presented in
the U.S. I am sure you will ask a few critical questions too if given the
chance. Looking forward to some news after September 10th.

/

Martin
 
I can't think of a better choice. I'm sure your contribution to the discussion will be both practical and given in a clear no-nonsense manner. After all, that is how you give us information all the time here on the forum.
 
Hi Al, glad that you will be involved in the decision making process. They need input from someone like you (you! in this case) with years of experience of working with Coumadin/warfarin along with your compassion for those of us who are struggling with it. It isn't often that I feel that the bureaucrats at any level (much less federal) have such good sense.

Will look forward to hearing how it goes.
 
Thanks but NO- thanks

Thanks but NO- thanks

I'll stay with my warfarin. 1 pill a day.. Get up, make coffee , put the cat outside and take my coumadin. :) When it's time for me to test. I do it before I take coumadin (Usually at 6 a.m.) and then I will know if I need to tweek or not. :p ..Don't want to have to remember to take another one at night.Bonnie
 
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