Johnson & Johnson (J&J) Pharmaceutical Research and Development has announced positive results from a Phase III EINSTEIN-Extension clinical trial to test the novel oral anticoagulant rivaroxaban.
During the trials, rivaroxaban showed a significant reduction in the risk of recurrent symptomatic venous thromboembolism (VTE) compared to placebo, in patients who had previously been treated for deep vein thrombosis (DVT) or pulmonary embolism (PE).
Rivaroxaban was well tolerated and patients showed a highly statistically significant relative risk reduction (RRR) of 82% in the recurrence of a symptomatic VTE1 versus those treated with placebo.
Amsterdam Academic Medical Centre’s Harry R Büller said that the results highlight the potential clinical benefit of extending prophylaxis for an additional six or 12 months beyond the recommended treatment duration.
“This study could help transform the way physicians treat patients, 10% of which still experience a recurrence within 12 months of the initial event,” Büller said.
To be eligible for enrollment, patients had to have previously completed six to 12 months of treatment with a vitamin K antagonist (VKA) or have participated in the ongoing Phase III EINSTEIN-DVT or EINSTEIN-PE trials, in which they were treated with either rivaroxaban or a VKA, for the same time duration.