For six decades, warfarin cemented its reputation as the world's most effective anticoagulant--and the most troublesome to dose appropriately. In recent years, a host of new agents have been vying to be the long-sought-after alternative to warfarin by posing fewer risks and doing away with the need for regular INR monitoring.
New laboratory data using human blood shed more light on the use of coagulation factors to reverse bleeding with newer anticoagulants; an online AHA presentation of the results yesterday led to much discussion on this issue among cardiologists and hematologists.
Two separate experiences with dabigatran from different US centers showing very different results, and new cost-effectiveness analyses with the new drugs were reported in a poster session at last week's ACC meeting.
In its final draft guidance, the UK National Institute for Clinical Excellence has recommendedrivaroxaban as an option for the prevention of stroke and systemic embolism in people with atrial fibrillation.
UPDATED // The FDA has granted priority review to rivaroxaban for the additional indication of ACS, meaning a decision will be made within six months of the filing of this application rather than 10. The agency has also extended the review time for apixaban for prevention of stroke in atrial fibrillation by three months, because of additional clinical information submitted by the manufacturers.
Dr Valentin Fuster sits down with Drs William Boden, John Chapman, Keith Fox, Anne Gillis, Jessica Mega, and Clyde Yancy to tackle the brave new world of antithrombotics and to ask whether academics have left the real world, and their patients, behind.
The US consumer group says there are several areas of uncertainty in the ROCKET-AF trial that raise questions as to whether rivaroxaban is as safe and effective as warfarin and asserts that the new indication should not be approved until further studies have been conducted to address these issues.
UPDATED WITH COMMENTARY//In the FDA briefing documents for the committee, which were posted online Tuesday, the clinical review recommends that a complete response letter be issued and that the drug's sponsor conduct additional studies before the FDA approves the latest anticoagulant on the scene for stroke prevention in atrial fibrillation.
With ROCKET-AF meeting its primary end point and now being published in the New England Journal of Medicine, the next step for the new oral anticoagulant will be the FDA advisory panel review in September.
CORRECTED // When the ESC was planning new guidelines on the treatment of atrial fibrillation, the task force expected to be able to include information on trials of many new anticoagulants that were about to come on the market. But only a few of these expected trials were complete when guidelines were published in September 2010, so the ESC is considering another update.
A new factor Xa inhibitor, apixaban, has cleared the penultimate hurdle on the road to EU approval for the prevention of venous thromboembolism in patients undergoing elective hip- or knee-replacement surgery.
It seems likely that there will be two new oral anticoagulants available in the not-too-distant future that can be used as an alternative to warfarin in the prevention of stroke in AF patients. But how do the two new agents compare with each other, and what about other possible indications and the host of other similar agents in development?
CORRECTED // The investigational factor Xa inhibitor edoxaban will not be developed for the prevention of VTE in the US and EU; rather, the company is concentrating its efforts on AF and treatment of VTE. For these indications, edoxaban will be racing another factor Xa inhibitor, apixaban, to market.