Bayer’s new DVT drug ‘could set new standards’

Bayer has said that a new treatment for deep vein thrombosis (DVT) could “set a new standard” for anticoagulation therapies.

The claim comes following the publication of the results of a phase II clinical trial for rivaroxaban, a novel oral anticoagulant. Bayer says the findings are “important” and will enable new phase III trials to take place.

Two programmes, entitled ODIXa-DVT and EINSTEIN-DVT, involved a total of 1,156 with acute, symptomatic DVT. They were given daily doses of rivaroxaban in the range of 20 to 60 milligrams, which was compared with the standard therapy of parenterally administered heparin (like enoxaparin), followed by an oral vitamin K antagonist like warfarin.

In the ODIXa-DVT study, the Bayer drug managed to reduce clot size after 21 days, with a low chance of venous thromboembolism returning. The incidence of bleeding, a sometimes common side-effect of anticoagulants, was reportedly low.

Robert Califf MD, director of the Duke Clinical Research Institute at Duke University, remarked: “I am very encouraged given the size and design of the programme.”

“We are hopeful that this new mechanism will lead to safer and more predictable anticoagulation than warfarin, and this programme is designed to make a definitive comparison of this new approach compared with the old standard of care,” he added.

One of the most recent drugs to be touted as a warfarin replacement was Exanta, the AstraZeneca anticoagulant. Like rivaroxaban, Exanta was said to set a new standard of care since the oral medication method would not require regular blood monitoring.

However, AstraZeneca withdrew the drug from development earlier this year following concerns about toxicity in the liver.

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