Patient Care

ONLINE EXCLUSIVE: Anticoagulant's Receives FDA Approval to Treat Deep Vein Thrombosis, Pulmonary Embolism


 

Rivaroxaban (Xarelto) has won another approval from the U.S. Food and Drug Administration (FDA). Already green-lighted for use to reduce the risk of DVT and pulmonary embolism (PE) after knee or hip replacement surgery—and reduce the risk of stroke in non-valvular atrial fibrillation patients—the anticoagulant therapy has been approved for use in the treatment of acute DVT and PE, and to reduce the risk of recurrent DVT and PE after initial treatment. It’s a landmark step that will likely have big implications for hospitalists.

“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,” Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said in a news release.

Single-drug therapy without the need for parental bridging treatment, or drug-level monitoring, is a breakthrough in the treatment of VTE, and represents a paradigm shift that we have not seen in a long time.


—Hiren Shah, MD, assistant professor of medicine, Northwestern University Feinberg School of Medicine, medical director, hospital medicine, Northwestern Memorial Hospital, Chicago

“Single-drug therapy without the need for parental bridging treatment, or drug-level monitoring, is a breakthrough in the treatment of VTE, and represents a paradigm shift that we have not seen in a long time for a very common emergency room and hospital-based medical condition,” says Hiren Shah, MD, assistant professor of medicine at Northwestern University’s Feinberg School of Medicine and medical director of hospital medicine at Northwestern Memorial Hospital in Chicago.

Ian Jenkins, assistant professor in the Division of Hospital Medicine at the University of California at San Diego, says factors that will help determine whether a patient is a candidate for rivaroxaban include the ability to pay for it; compliance, because the duration of effect is shorter than it is for warfarin; and good and stable renal function.

“We now have the first approved oral warfarin alternative for VTE, and for appropriate candidates, it's a more convenient if not better treatment,” Dr. Jenkins says. “The main downside is that warfarin remains reversible, and the new drugs are minimally so.”

Dr. Shah predicts a more efficient discharge process, which, for rivaroxaban patients, will no longer include arranging for international normalized ratio (INR) monitoring or time-consuming counseling on taking injections and drug interactions with vitamin-K antagonists.

“That’s a very complex, 30-minute process,” says Dr. Shah, who also who runs Northwestern’s VTE-prevention program. “With a single agent, I think the value here is you don’t need that complex care coordination anymore, and that’s time-saving for a hospitalist.”

Dr. Shah notes coordination of care will still be very important with this indication, especially because the dose for rivaroxaban in the treatment of acute DVT changes from twice a day to once a day starting at Day 21. “Whatever education initiatives we undertake, they have to extend that entire spectrum,” he adds.

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