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Format: 04/23/2014
Format: 04/23/2014


Warfarin Alternative Gets FDA Nod; West Penn Hospital Part of Clinical Trials Leading to Rivaroxaban Approval

Monday, July 11th, 2011

PITTSBURGH  –  The U.S. Food and Drug Administration (FDA) on July 1 approved rivaroxaban (Xarelto) as an alternative to warfarin (Coumadin) for prevention of deep-vein thrombosis (DVT) in patients undergoing hip and knee replacement.

Rivaroxaban, the subject of three Phase III clinical trials at West Penn Hospital, is also being developed for treatment of acute DVT and PE, prevention of recurrent DVT and for prevention of stroke in patients with atrial fibrillation.

“Warfarin has been the only oral anticoagulant available for the last 60 years, and can be difficult to dose correctly,” said hematologist Margaret Kennedy, MD, Medical Director of the WPAHS System Anticoagulation clinics and Principal Investigator in the three trials. “We are happy to finally see an effective option to warfarin and expect to see its use expanded to benefit even more patients.”

Dr. Kennedy is the only local investigator in the EINSTEIN DVT and EINSTEIN-Extension trials, the results of which were reported last year in the New England Journal of Medicine (NEJM) and were cited in the FDA’s decision to approve rivaroxaban for patients undergoing hip or knee replacement surgery.

Two randomized trials of rivaroxaban studied its use in the treatment of acute DVT and the treatment of acute pulmonary embolism. The latter trial is ongoing, though enrollment is closed. A third EINSTEIN trial studied the continued treatment of patients with DVT or acute pulmonary embolism. Drug therapy for such patients in many cases now ends after 6 to 12 months, mostly due to the possibility of bleeding when on warfarin.

DVT is a common and sometimes deadly disorder with a significant risk of recurrence. The standard treatment of administering heparin via injection, followed by administration of a Vitamin K agonist such as warfarin, presents numerous challenges.

“Warfarin treatment requires regular laboratory monitoring,” Dr. Kennedy said. “Any variation from the optimal dose could lead to recurrence of blood clots or dangerous bleeding. Food and drug interactions can also cause difficulties for patients.”

The EINSTEIN studies found that rivaroxaban provides a safe, effective single-drug approach to the initial and continued treatment of venous thrombosis, according to the NEJM. Patients treated with rivaroxaban also experienced significantly lower rates of recurrent DVT than those who were treated with warfarin.

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