Rivaroxaban, an experimental oral anticoagulant to treat deep vein thrombosis by Bayer Healthcare, has been shown to cut over 80% relative risk in patients.
Rivaroxaban in 20 mg once-daily dosage significantly reduced the risk of recurrent symptomatic venous thromboembolism (VTE) compared to placebo in patients who have been treated for a previous deep vein thrombosis (DVT) or pulmonary embolism (PE), Bayer announced while presenting the first phase III data at the Annual Meeting of the American Society of Hematology in New Orleans, LA.
Rivaroxaban is marketed under the brand name Xarelto.
Rivaroxaban showed an 82% relative risk reduction in the recurrence of symptomatic VTE over patients treated with placebo.
Rivaroxaban also helped to cut down the rate of major bleeding.
EINSTEIN comprised three clinical studies in approximately 8,000 patients. Two of these studies enrolled patients with acute, symptomatic deep vein thrombosis (EINSTEIN-DVT, enrollment complete) or pulmonary embolism (EINSTEIN-PE).
In these two trials, patients received oral rivaroxaban 15 mg twice-daily for the first three weeks, followed by oral rivaroxaban 20 mg once-daily, compared with initial enoxaparin treatment followed by a vitamin K antagonist.
The third study, EINSTEIN-EXT, compared the efficacy and safety of rivaroxaban to placebo in the secondary prevention of recurrent symptomatic venous blood clots by extending preventative treatment by 6 or 12 months beyond a previously completed regimen of 6 or 12 months of therapy, and enrolled approximately 1,200 patients from 28 countries around the world with symptomatic DVT or PE.
Patients must have previously completed 6 or 12 months of treatment with a vitamin K antagonist for an acute episode of VTE or had participated in the ongoing Phase III EINSTEIN-DVT or EINSTEIN-PE trials, in which patients were treated with either rivaroxaban or a VKA, for the same duration of time, to be eligible for enrollment in EINSTEIN-EXT.
Patients were then randomized to receive either 20 mg of rivaroxaban dosed once-daily, or a placebo, and were evaluated for an additional 6 or 12 months.
“The results from EINSTEIN-EXT highlight the potential clinical benefit of extending prophylaxis for an additional 6 or 12 months beyond the currently recommended treatment duration,” sated Harry R. Büller, M.D., Academic Medical Center in Amsterdam, Netherlands.
This study could help transform the way physicians treat patients who have previously suffered a DVT or PE. Currently, up to 10% of patients who are treated adequately, according to today’s recommended guidelines, still experience a recurrence within 12 months of the initial event, Mr Büller added.
This is the fifth study in a row in a total of more than 13,500 patients, in which rivaroxaban has shown consistent benefit in reducing the risk of VTE in patients.
Rivaroxaban has previously demonstrated superior efficacy to the current standard treatment in the prevention of VTE after orthopedic surgery in all four RECORD trials, Bayer stated in a press release.
Approximately two million cases of deep vein thrombosis and nearly 600,000 pulmonary embolism cases are reported each year in the United States.
Rivaroxaban is currently under review by the U.S. Food and Drug Administration as one tablet, once-daily for the prophylaxis of deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients undergoing hip or knee replacement surgery.
Bayer submitted the new drug application (NDA) for rivaroxaban through Johnson & Johnson Pharmaceutical Research & Development, L.L.C., on behalf of Ortho-McNeil Inc., on July 28, 2008. In March 2009, an FDA Advisory Committee agreed by a vote of 15-2 that the available clinical data for rivaroxaban demonstrated a favorable benefit-risk profile. In May 2009, the FDA issued a Complete Response Letter for the NDA for rivaroxaban.
Rivaroxaban has been granted approval for the prevention of VTE in adult patients undergoing elective hip or knee replacement surgery in over 80 countries, including the EU, Australia, Canada, China and Mexico. To date, Xarelto has been launched in more than 50 countries by Bayer HealthCare.
If approved by the FDA, Ortho-McNeil, a division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. (a Johnson & Johnson Company), will commercialize rivaroxaban in the U.S. The U.S. Bayer HealthCare sales force will support the Ortho-McNeil sales force by detailing rivaroxaban in designated hospital accounts. Bayer HealthCare is exclusively responsible for the marketing of rivaroxaban in countries outside the U.S.
Bayer Schering Pharma is a worldwide leading specialty pharmaceutical company. Its research and business activities are focused on the following areas: Diagnostic Imaging, General Medicine, Specialty Medicine and Women’s Healthcare.