More Patients to Benefit From New Anti-clotting Drug
Tuesday, November 20, 2012 - Campus News - Contact Theresa Green, (405) 833-9824
Researchers at the University of Oklahoma Health Sciences Center played an important role in research that led to the decision that makes a newer anti-clotting treatment available to more patients.
The U.S. Food and Drug Administration just expanded the approved use of Xarelto (Rivaroxaban) to include treating deep vein thrombosis (DVT) or pulmonary embolism (PE), and to reduce the risk of recurrent DVT and PE following initial treatment.
DVT is a blood clot that forms in a vein deep in the body. Most deep vein blood clots occur in the lower leg or thigh. When a blood clot in a deep vein breaks off and travels to an artery in the lungs and blocks blood flow, it results in a potentially deadly condition called PE.
"This will improve the care of an estimated 600,000 patients each year in the United States who require treatment for DVT or PE," said Gary Raskob, Ph.D., an internationally recognized expert on DVT and dean of the OU College of Public Health.
Raskob was a member of the Steering Committee that designed and oversaw the clinical research evaluating the safety and effectiveness of Xarelto in patients with DVT or PE. This included three clinical studies that enrolled a total of 9,477 patients, including patients at the OU Health Sciences Center.
The research showed using Xarelto, a single drug given in a fixed dose, was as effective as standard treatments, which require injections of the drug heparin, combined with the oral drug warfarin as well as regular blood testing and dose adjustment in each patient. The research also showed that Xarelto reduced serious bleeding side effects that can occur, and that extended treatment with the drug reduced the risk of recurrent DVT or PE in patients.
"We are excited to have been able to participate in a study that has helped advance the way we care for patients with deep vein thrombosis," said Dr. Suman Rathbun of the OU Vascular Center. "Prevention is paramount; however, since we are not yet able to prevent 100 percent of these blood clots, it is vital for us to continue to work toward new and improved treatments."
Xarelto is already FDA-approved to reduce the risk of DVTs and PEs from occurring after knee or hip replacement surgery (July 2011), and to reduce the risk of stroke in people who have a specific type of abnormal heart rhythm (November 2011).
The FDA indicates it reviewed Xarelto's new indication under the agency's priority review program, which provides an expedited six-month review for drugs that offer major advances in treatment or that provide treatment when no adequate therapy exists.
"Xarelto is the first oral anti-clotting drug approved to treat and reduce the recurrence of blood clots since the approval of warfarin nearly 60 years ago," said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research.
Scientists at OU and their colleagues worldwide are working diligently to find better and more practical tools to prevent and treat blood clots and pulmonary embolism. At least 100,000 deaths from PE are believed to occur each year in the United States, according to the U.S. Surgeon General. This is more deaths than caused by breast cancer, HIV disease, and motor vehicle crashes
Other drugs approved by FDA to treat or reduce the risk of blood clots include Lovenox (enoxaparin), generic versions of enoxaparin, Arixtra (fondaparinux), Fragmin (dalteparin), Coumadin (warfarin), and heparin.
Xarelto is marketed by Raritan, N.J.-based Janssen Pharmaceuticals Inc.
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