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Bayer HealthCare announced today that the U.S. Food and Drug Administration (FDA) has approved Xarelto^® (rivaroxaban tablets), the first once-daily, oral anticoagulant for the prophylaxis of deep vein thrombosis (DVT) which may lead to a pulmonary embolism (PE) in patients undergoing knee or hip replacement surgery. Xarelto^® is approved for use at a 10 mg dose, one tablet, once-daily for 35 days following hip replacement and for 12 days following knee replacement surgery. Xarelto^® is the only new oral anticoagulant with US approval in VTE prophylaxis for patients undergoing knee or hip replacement surgery.

“The approval of once-daily Xarelto^® tablets will provide a new option to help protect patients in the US from developing venous blood clots following knee or hip replacement surgery,” said Louis M. Kwong, M.D., professor of orthopedic surgery at Harbor-UCLA Medical Center, who was involved with the rivaroxaban clinical trial program in this indication. “Xarelto^® has a proven clinical benefit over one of today’s most widely used options in preventing these potentially life-threatening blood clots, and the use of a once-daily pill may play an essential role in helping to simplify clinical practice.”

According to the American Academy of Orthopedic Surgeons, more than 800,000 Americans undergo knee or hip replacement surgery each year. These procedures are associated with an increased risk for DVT, a blood clot that forms in a deep vein, usually in the leg. If all or part of a DVT breaks off, it can travel to the lungs and cause a PE, where it may impact the flow of oxygenated blood and lead to potentially life threatening consequences.

The American College of Chest Physicians recommends the use of blood thinners (anticoagulants) immediately following knee or hip replacement surgery and extended use post-discharge (at least 10 days for knee replacement, and up to 35 days for hip replacement) to help reduce such risks. However, full compliance with these guidelines using previously available options has not been widely observed. DVT and PE are the leading causes of re-hospitalization following joint replacement surgery.

“The use of blood thinners has been shown to safely and effectively help people from developing preventable blood clots,” said Alan Brownstein, Chief Executive Officer of the National Blood Clot Alliance. “The FDA approval of a new blood thinner, Xarelto^®, offers a new option for patients seeking knee or hip replacement surgery, and we encourage people to discuss with their physicians the risk of blood clots and which blood thinner offers optimal protection as part of their pre-surgical consultation.”

Phase III data from the Xarelto^® clinical development program showed superior efficacy of rivaroxaban, both in head-to-head comparison with enoxaparin and when comparing extended-duration (5 weeks) rivaroxaban with short-duration (2 weeks) enoxaparin followed by placebo. In these trials, rivaroxaban and enoxaparin demonstrated similar safety profiles including low rates of major bleeding.