Bayer and Johnson & Johnson have reported more Phase III data at the annual meeting of the American Society of Haematology which show the superiority of their experimental antithrombotic Xarelto over Sanofi-Aventis’ Lovenox.
Over the weekend, the firms presented data from the RECORD1 study which demonstrated a 70% relative risk reduction for Xarelto (rivaroxaban) in total venous thromboembolism when compared with enoxaparin and an 88% RRR in major VTE. Now results from two other last-stage trials makes equally impressive reading.
In a second trial, which also involved hip-replacement patients and is called RECORD2, 79% experienced fewer total clots and again an 88% RRR in major VTE, compared with Lovenox. Patients in both arms of the study had a similar rate of major bleeding, although rivaroxaban was taken for an extended period of some 35 days, compared with only up to 14 days for Sanofi’s drug. In RECORD3, in knee-replacement patients, there was a 49% and 62% reduction in total and major clots respectively for patients on Xarelto.
Alexander Turpie, professor of medicine at McMaster University, Canada and principal investigator in the RECORD programme, said that the trials are showing “unprecedented results in major orthopaedic surgery for the prevention of VTE and this is genuinely exciting”. He added that in “three different trials across large patient populations, we have seen rivaroxaban outperform the current standard of care, enoxaparin, without compromising on safety. This is strong clinical evidence that we are making a major leap forward in oral anticoagulation”.
Prof Turpie continued by saying that in RECORD2 and 3, “we are seeing clinically relevant reductions in symptomatic VTE for the first time in orthopaedic surgery. These results are a major milestone in the evolution of anticoagulation therapy”. Bayer and J&J are also conducting earlier-stage trials to determine whether Xarelto can prevent strokes among patients with atrial fibrillation.
