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LUVMyBirman

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I posted this awhile back before we had the 'new advancements' section sorted out. If you have additional questions..... VR.com member Marty Thomas, MD has met with other physicians involved in this study. He may be able to shed some more light on this subject for us.



New Pill Looks Promising for Blood Clots

By EMMA ROSS
.c The Associated Press


LONDON (AP) - A new blood-thinning pill seems to work at least as well as the standard treatments for warding off blood clots, but kicks in more quickly and could be safer and easier to take, research indicates.

Scientists who were presented with the evidence at a medical conference this week in Paris said Wednesday that the new drug, Exanta, could dramatically improve the quality of life of millions of people.

It would be the first anti-clotting pill of its type to emerge since warfarin, also known as Coumadin, was introduced more than 50 years ago.

The research, presented at a meeting of the International Society of Thrombosis and Hemostasis, showed the drug prevented blood clots in the legs of people undergoing hip or knee surgery just as successfully as warfarin or injectable drugs, known as low molecular weight heparins. People undergoing such surgery have the highest risk of developing a potentially fatal clot.

Dr. Sylvia Haas, a blood clotting expert who was not connected with the research, said the results showed the new drug appears to overcome the shortcomings of the current medicines.

``I'm really fascinated by what has been achieved,'' said Haas, head of thrombosis research at the Technical University in Munich, Germany. She was involved in the development of injectable heparins. ``It's premature to discuss whether this could save lives, but there will certainly be a lot of improvement in the quality of life for the patients.''

The main gripes with warfarin are that its performance is influenced by food containing vitamin K and by other drugs, and that it is difficult to get the dose right. Patients must have regular blood tests to monitor their blood and must adjust the dose accordingly. Too much of the drug can cause dangerous bleeding.

Also, Coumadin takes some time to work.

For that reason, doctors often also use the injectable heparins, which takes effect immediately.

Although low molecular weight heparins do not require blood thickness monitoring, they are injected into the belly, which can be inconvenient. They also increase the risk of osteoporosis.

The new drug is not affected by food and patients using it don't require injections or regular monitoring of blood thickness.

Dr. David Myerson, a cardiologist at Johns Hopkins University and an American Heart Association spokesman, said he was encouraged by the findings but that there is more to prove before the drug should be widely used.

If it proves successful for other conditions, such as irregular heart beat, stroke or artificial heart valves, its wide applicability would be ``striking,'' he said.

Exanta, made by AstraZeneca, intervenes in the blood clotting process at a later stage than Coumadin or heparin. Doctors can also give a broader dose range without creating bleeding problems.

The latest research consisted of two studies. One compared Exanta to Coumadin in 680 knee replacement patients in Canada and the United States. The other pitted the drug against low molecular weight heparins in 2,788 Europeans getting new hips or knees.

Experts say Exanta could become available within a year. They envision it being used in combination with blood thinners that attack clots from a different angle, such as aspirin or Plavix. It is not designed to replace such medicines, scientists said.
 
Results Presented at American Society for Hematology
WILMINGTON, DE ? December 10, 2001 ? Interim results of a Phase II trial comparing AstraZeneca's investigational oral direct thrombin inhibitor EXANTA (ximelagatran) to warfarin for the prevention of strokes in patients with chronic nonvalvular atrial fibrillation (NVAF) showed 0.9 strokes and 0.4 transient ischemic attacks (TIAs) per 100 treatment years (3 events) for patients on EXANTA and 2.6 strokes and 2.6 TIAs per 100 treatment years (4 events) for patients on warfarin.

Results of the SPORTIF IV trial were presented today at the 43rd annual meeting of the American Society of Hemotology in Orlando, Florida. Both strokes observed in the patients treated with EXANTA were ischemic and non-fatal. Both strokes observed in the warfarin-treated patients were hemorrhagic and fatal.

SPORTIF IV is a long-term, open-label continuation of SPORTIF II, a 12-week randomized dose-finding study. In SPORTIF IV, 125 patients with chronic NVAF and at least one additional stroke risk factor received fixed-dose EXANTA (36 mg bid) and 42 patients received warfarin (dose-adjusted to an INR of 2-3). Patients have been treated for between 21 and 24 months; the study is ongoing. These preliminary results need to be confirmed in larger-scale clinical trials.

The incidence of major bleeding was 0.9 per 100 treatment years with EXANTA and 2.6 per 100 treatment years with warfarin. In the combined SPORTIF II/IV clinical trials, liver enzyme levels of at least three times the upper limit of normal were observed in approximately five percent of patients treated with EXANTA. None of these patients was symptomatic, and enzyme levels decreased during continued treatment or discontinuation of therapy.

EXANTA is the first oral direct thrombin inhibitor under Phase III investigation. The mechanism of action of EXANTA is to inhibit the activity of a clot-forming enzyme called thrombin, which is critical to the final step in the formation of blood clots. Ongoing clinical studies utilize a fixed dose of EXANTA without routine coagulation monitoring.

According to the American Heart Association, atrial fibrillation is found in about two million Americans. During atrial fibrillation, the two small upper chambers of the heart, called the atria, quiver instead of beating effectively. Blood in these quivering chambers can pool and clot. If a piece of the blood clot travels to an artery in the brain and becomes lodged, a stroke may result. About 15 percent of strokes in the US occur in people with atrial fibrillation.

AstraZeneca (NYSE:AZN) is a major international healthcare business engaged in the research, development, manufacture and marketing of ethical (prescription) pharmaceuticals and the supply of healthcare services. It is one of the top five pharmaceutical companies in the world with healthcare sales of $15.8 billion and leading positions in sales of cardiovascular, gastrointestinal, oncology, anesthesia (including pain management), central nervous system (CNS) and respiratory products. In the United States, AstraZeneca is an $8 billion healthcare business with more than 10,000 employees.

For more information about AstraZeneca please visit www.astrazeneca-us.com
 

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