The FINANCIAL — Johnson & Johnson Pharmaceutical Research and Development, L.L.C. (J&JPRD), announced on December 6 that results from the Phase III EINSTEIN-Extension (EXT) clinical trial of the novel oral anticoagulant rivaroxaban showed a significant reduction in 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).
The rate of major bleeding was low. The findings were reviewed at today’s press briefing during the 51st Annual Meeting of the American Society of Hematology (ASH), and will be fully presented as part of the late-breaker session of the general meeting at 7:30 AM CST, Tuesday, December 8th.
To be eligible for enrollment in EINSTEIN-EXT, patients had to have previously completed six to 12 months of treatment with a vitamin K antagonist (VKA) for an acute episode of VTE 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. Upon enrolling in EINSTEIN-EXT, patients were randomized to receive either 20 mg of rivaroxaban dosed once-daily or placebo and were evaluated for an additional six or 12 months.
Rivaroxaban was well tolerated. Patients treated with rivaroxaban showed a highly statistically significant relative risk reduction (RRR) of 82% in the recurrence of a symptomatic VTE1 versus those treated with placebo [1.3% vs. 7.1%, (p<0.0001), respectively].
“The results from EINSTEIN-EXT highlight the potential clinical benefit of extending prophylaxis for an additional six or 12 months beyond the currently recommended treatment duration,” said Harry R. Büller, M.D., Academic Medical Center in Amsterdam. “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.”
Rates of major bleeding,3 the primary safety endpoint, were low and not statistically significantly different between the two groups [0.7% vs. 0.0%, (p=0.11) for the rivaroxaban and placebo arms, respectively].
A secondary endpoint measuring the composite of major and clinically relevant non-major bleeding4 showed a statistically significant difference between the two groups [6.0% vs. 1.2%, (p<0.001) in the rivaroxaban and placebo arms, respectively]. No cases of serious liver injury were reported in either group. Liver safety results included: ALT >3x ULN + T Bili >2x ULN: 0.0%5 in both groups; ALT >3x ULN: 1.9% in the rivaroxaban arm and 0.5% of patients in the placebo arm. There were no differences in cardiovascular-related events between the two treatment groups.
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