Bayer AG's experimental pill rivaroxaban is significantly more effective than standard injections of Lovenox in preventing blood clots after knee surgery, researchers said on Sunday. The news confirms the German drugmaker's leadership in the multibillion-dollar race to bring a new class of oral anticoagulants to market.
Results of a large Phase III trial showed only 9.6 percent of patients given rivaroxaban experienced venous thromboembolism (VTE), or blood clots, following total knee replacement against 18.9 percent of those on Sanofi-Aventis SA's Lovenox.
Major life-threatening VTE occurred in 1 percent of rivaroxaban patients against 2.6 percent for the Lovenox group. Lead investigator Dr Michael Lassen, an orthopaedic surgeon at Hoersholm Hospital, University of Copenhagen, said it was exciting that a once-daily pill had proved better than the current gold standard injection therapy.
"It's very important," he said in a telephone interview. "Instead of having an injectable when a patient goes home, it is much more convenient with an oral drug and there is also no need for monitoring."
Lassen presented results from the 2,531-patient study at the International Society on Thrombosis and Haemostasis meeting in Geneva. Bayer and rivals have been seeking new anticoagulants since Exanta, a once-promising medicine from AstraZeneca Plc failed to win US Food and Drug Administration approval in 2004 after being associated with liver toxicity.
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