Bayer has presented more positive data on Xarelto which the firm says underlines the superior efficacy of the anticoagulant compared with the current gold standard treatment, Sanofi-Aventis’ Lovenox.
Bayer and partner Johnson & Johnson presented pooled results from the four RECORD studies at the American Society of Hematology meeting in San Francisco which confirm that Xarelto (rivaroxaban) was superior to Lovenox (enoxaparin) for the prevention of venous thromboembolism after total knee or hip replacement surgery. The data, which involves 12,500 patients, shows that the Bayer/J&J drug reduces symptomatic VTE and death following knee or hip replacement surgery by more than 50% compared to enoxaparin.
The pooled study also revealed low rates of major bleeding that were not statistically significant different from the comparator. The RECORD programme has demonstrated that Xarelto is the only oral anticoagulant to show clinical benefit in head-to-head comparison against enoxaparin, as well as when comparing extended duration (five weeks) rivaroxaban with short-duration (two weeks) Lovenox.
The study’s principal investigator, Alexander Turpie of the McMaster University in Canada, said the combination of the efficacy and the safety profile of Xarelto “may help change clinical practice to more accurately reflect established anticoagulation guidelines which are in place to protect patient lives”. He added that all the results reported from the RECORD programme “strengthen my belief that direct Factor Xa inhibition with rivaroxaban has the potential to revolutionise the way we prevent the formation of dangerous blood clots”.
Xarelto was approved in Europe in October and has been filed with regulators in the USA. Bayer believes the drug will be a 2 billion euro blockbuster when all the possible indications for rivaroxaban, especially as a treatment for stroke in patients with atrial fibrillation, are approved.
