New Drug For Deep Vein Thrombosis Eases Treatment Regimen

Deep vein thrombosis (DVT) occurs when a clot forms in one of the inner veins of the leg and can worsen into pulmonary embolism if the clot breaks away and travels to the lungs. Nearly 300,000 people in the United States die each year from these blood clots, greater than the number of people who die from AIDS, breast cancer, and automobile accidents combined. A study on a new drug for these conditions, which can be taken less often than the current treatment and therefore ease the burden faced by some patients, is being presented today during the 48th Annual Meeting of the American Society of Haematology (ASH(TM)).

"In the past decade, the introduction of low-molecular-weight heparin was a major breakthrough in the treatment of venous blood clots, paving the way for outpatient treatment. Now, idraparinux has the potential to further advance the treatment of this common -- and potentially deadly -- condition," said ASH President Kanti R. Rai, MD, of Long Island Jewish Medical Centre and the Albert Einstein College of Medicine.The limitations of current treatments include the need for daily injections, adverse interactions with food and many types of drugs, and a wide variation in treatment results requiring intensive monitoring of patients. More than 5,000 patients (2,904 with deep vein thrombosis and 2,215 with pulmonary embolism) participated in this comparative study looking at standard treatment versus idraparinux.Patients were randomized to either receive idraparinux (by subcutaneous injection once a week) or the standard daily treatment regimen of low- molecular-weight heparin followed by a vitamin K inhibitor for three to six months. The researchers' primary measure of success was whether a symptomatic venous clot would reoccur three months after treatment.In the DVT group, idraparinux was found to be just as effective as the low-molecular-weight heparin regimen, with a nearly identical incidence of reoccurrence: 2.9 percent in the patients taking idraparinux and 3 percent in the control group. Severe bleeding -- a common side effect of anticoagulants - - occurred in 4.5 percent of the DVT patients taking idraparinux and in 7 percent of those receiving traditional treatment. By six months, the bleeding rates became similar.In the pulmonary embolism group, the incidence of blood clot reoccurrence after three months was 1.6 percent in the control group and higher -- 3.4 percent -- in those taking idraparinux, showing that the new drug was not as effective as the standard treatment in these patients."Although the results for idraparinux in the pulmonary embolism group were surprising and disappointing, for patients with deep vein thrombosis our findings should have a remarkable impact," said Harry Buller, MD, Chairman of the Department of Vascular Medicine at the Academic Medical Centre in Amsterdam and lead study author. "The fact that once-a-week injections of idraparinux are just as effective and safe as traditional treatment frees patients with DVT from the daily injections and continuous monitoring that would otherwise be required." (Source: American Society of Haematology: Albert Einstein College of Medicine : December 2006.)