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New Drug may allow persons not to need blood monitoring for warfarin
Special to the Post-Dispatch
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The rat poison, warfarin (coumadin), is used in low doses to protect persons from geting blood clots in the leg and lung and to stop strokes in persons with atrial fibrillation. The problem with warfarin is it often causes severe bleeding, necessitating frequent blood draws to maintain the lowest possible dose that is effective. The multiple needle sticks represent a major hassle for persons taking warfarin.

Thrombin is a protein in the blood that  promotes the formation of blood clots. Recently a drug called, Dabigatran, has been discovered. This drug with an unpronounceable name blocks thrombin and therefore stops blood clots from forming. It is taken twice daily and does not require blood monitoring.

A study in this weeks New England Journal of Medicine found that dabigatran  was was as effective as warfarin in stoping persons who had a blood clot in their leg from getting a second clot. Bleeding episodes occured no more often than it did with warfarin. The blood did not require blood monitoring.

Previous studies have shown that dabigatran  is superior to warfarin in preventing strokes in persons with atrial fibrillation. In that study it was also safer than warfarin. It also appears to work as well as heparin-like substances, which need to be given by injection, in preventing blood clots after knee and hip joint replacement. This drug, unlike warfarin, does not interact with food. It is not yet approved by the Food and drug Administration (FDA).

The BOTTOM LINE: This new drug  may make warfarin obsolete. It will not only be as effective but it will be hassle free. Importantly it will also allow persons who normally spend excess time in hospital waiting for their blood tests (INR) to be therapeutic when warfarin is started to go straight home. Like all drugs it will have side effects that we do not yet know about, but it will change the lives of many persons who need to take warfarin. As the drug is excreted from the body through the kidney it will be necessary to adjust the dose in persons whose kidneys are not working well. This may be a real problem for many older persons.

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4 Comments

  1. Dr. John Morley  December 17, 2009 at 11:22 UTC

    Vitamin K has effects on the cloting cascade but this appears not to be a major problem wuth this new drug.

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  2. yulia brockdorf  December 17, 2009 at 10:50 UTC

    are there any vitamin K related nutritional implications with dabigatran?

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  3. Dr. John Morley  December 15, 2009 at 12:01 UTC

    The above comments are very well taken. I tried to point this out by using “may” in the title and talking about side effects we do not yet know about. The compliance point for a twice a day drug is very real. Nevertheless I do not think the trials were that far away from the real world. Warfarin is a very difficult drug to manage and patients strugle with the hassales. the decreased hospitalisation time may well make the new drug not only friendlier for patients but also cost effective. time will tell.

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  4. Gary B Liska  December 15, 2009 at 11:33 UTC

    A key missing ingredient to new and improved oral anticoagulants is the need for near perfect compliance much less a good income to afford a next generation oral anticoagulant. Compliance for chronic, asymptomatic-relief products is approximately 50% at the 6 month mark. Given the cost of stroke, placing 100% of the future in an oral agent that does not allow practical monitoring as home INR testing does may just be a great drug in clinical trials. Real-world compliance may make people think twice how valuable practical monitoring is for an effective and affordable drug such as warfarin.
    Additionally, trials for dabigatran used many sub-stanrdard, non-systematic clinics for their efficacy comparison – none evaluted high quality services incorporating home INR testing. As often is the case with reporting of breakthrough drugs is the cost-effective evaluation that never seems to be as exciting to report.

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