Researchers also have tested the new drug, ximelagatran, for prevention of stroke, heart attacks and deep vein thrombosis, and if approved by the FDA it would offer millions of patients an alternative to the commonly prescribed anticoagulant, warfarin.
Results of the UR study are reported in the Oct. 30, 2003, New England Journal of Medicine, which in this issue paid special attention to scientific advances in the treatment of blood clots, or thrombosis. Two other major clinical trials also are reported.
Lead author Charles W. Francis, M.D., University of Rochester professor of Medicine and Pathology and Laboratory Medicine, says ximelagatran has now been studied in some 17,000 patients during the past five years. Ximelagatran was developed as an alternative to oral warfarin (brand name: Coumadin), in an effort to find a drug that was easier for patients and doctors to manage. Warfarin requires constant laboratory monitoring, and has a long list of side effects and food and drug interactions. Studies show ximelagatran is absorbed quickly, does not require adjustments or close monitoring, and has no food or drug interactions.
"Coumadin is a fine drug, but lots of people don't do well on it," Francis says. "We've been 50 years with no alternative and now it looks like we have one."
Blood clots occur in 40 to 80 percent of patients after total knee replacement surgery; clots are also a serious risk for the one-to-two million Americans a year diagnosed with atrial fibrillation, a heart rhythm disorder, or who suffer heart attacks. In addition, doctors treat a half-million individuals annually for deep-vein thrombosis or pulmonary embolisms, and thousands of others need prophylactic therapy. All of these patient
Contact: Leslie Orr
University of Rochester Medical Center