In DVT, PE, rivaroxaban shows similar efficacy, reduces major bleeding by nearly half compared to standard treatment

September 27, 2013

A new study may set a new standard for the treatment of venous thromboembolism (VTE) with a single oral anticoagulant.

Dr AnsellA new study may set a new standard for the treatment of venous thromboembolism (VTE) with a single oral anticoagulant.

A pooled analysis of the phase 3 EINSTEIN trial program, evaluating more than 8,000 patients, showed rivaroxaban (Xarelto, Janssen) is as effective as the standard of care in reducing the risk of deep vein thrombosis (DVT) and pulmonary embolism (PE) in people with symptomatic DVT or PE, while reducing the incidence of major bleeding by 46%. The analysis also found safety and efficacy outcomes for Xarelto were consistent across 4 subgroups of participants: fragile subjects, those with cancer, subjects with a history of a recurrent VTE and those presenting with a large clot.

The study showed that rivaroxaban was essentially similar in efficacy to standard therapy for DVT or PE, but that major bleeding was significantly decreased compared to standard therapy, according to Jack E. Ansell, MD, MACP, professor of medicine at New York University School of Medicine.

The net clinical benefit (combination of efficacy and safety; ie, recurrent VTE + major bleeding) was significantly positive with a 23% risk reduction compared to standard therapy.

“The study may change the paradigm of therapy: a 1-drug approach to the treatment of venous thromboembolism is not only effective, but possibly safer than the standard 2-drug regimen [parenteral agent in hospital followed by oral therapy],” Dr Ansell told Formulary. These studies may set a new standard for the treatment of VTE.”

The single oral anticoagulant is simple to use without the need for monitoring and with the ability to treat patients entirely as outpatients, according to Dr Ansell. “This therapy allows patients who are not serious incapacitated by their VTE to be treated entirely as outpatients-both DVT and PE-and significantly reduces hospital admissions and healthcare-related costs.”

 

“This simplifies therapy tremendously, especially compared to the problems of monitoring a drug such as warfarin and reduces some of the worse side effects of warfarin therapy, intracranial and retroperitoneal bleeding,” he said.

 

DVT is a condition in which blood clots form in 1 of the large, deep veins, usually in the legs. PE is a serious condition that most commonly occurs when part or all of a DVT dislodges and travels to the lung, via the heart, where it can partially or completely block a branch of the pulmonary artery. When PE occurs with large clots, multiple clots, or when the patient already has pre-existing heart or lung disease, the event may be fatal. Up to 900,000 Americans experience a DVT or PE each year, resulting in up to 300,000 deaths. 

Dr Ansell has been a paid consultant to Janssen Pharmaceuticals, Inc.