Pradaxa and Eliquis gain trial boost over warfarin
pharmafile | August 31, 2011 | News story | Sales and Marketing | Eliquis, Pradaxa, Xarelto, apixaban
A pair of new blood thinners are superior to warfarin when it comes to reducing the risk of stroke in atrial fibrillation (AF) patients, according to new research.
In data published at the European Society of Cardiology (ESC) Congress 2011 in Paris, Boehringer Ingelheim’s Pradaxa (dabigatran etexilate) and Bristol-Myers Squibb/Pfizer’s Eliquis (apixaban) fared better than the standard of care.
In Pradaxa’s case, this was already known from the RE-LY trial, but two sub-group analyses now show it reduces the risk of stroke compared to well-controlled warfarin – whether or not patients were taking antiplatelet therapy or treatments such as P-glycoprotein inhibitors.
Meanwhile, in the phase III ARISTOTLE trial, Eliquis – a new oral direct Factor Xa inhibitor – reduced the risk of stroke or systemic embolism by 21%, major bleeding by 31% and mortality by 11% in more than 18,000 AF patients who had at least one risk factor for stroke.
Earlier this month, Pradaxa become the first drug in 50 years to be approved by European regulators for stroke prevention in this patient group, following approval in the US, Canada, Japan and Australia.
Eliquis is not approved in this indication in any country, although it has been given the nod in Europe – like Pradaxa – to prevent venous thromboembolic events in patients who have had hip or knee replacements.
Boehringer says the Pradaxa findings are significant because warfarin “is known to interact with numerous medications, including many common co-medications metabolised via the Cytochtrome P450 pathway”.
An antiplatelet analysis assessed the combined use of aspirin and/or Sanofi-Aventis/BMS’s ageing blockbuster Plavix (clopidogrel) in 8,507 patients taking either Pradaxa (150mg or 110mg) or warfarin.
The second sub-group analysis looked at interactions with Pradaxa and P-glycoprotein inhibitors including amiodarone, verapamil and diltiazem.
“The safety of antiplatelet therapy in combination with anticoagulants has been a physician concern, with the combination shown to increase major bleeding over the use of anticoagulation alone,” the manufacturer added in a statement.
The most common sustained heart rhythm condition, AF sufferers are more likely to experience blood clots, thus increasing their risk of stroke.
The manufacturers of the two drugs, along with Bayer’s Xarelto (rivaroxaban), have been looking to supplant warfarin in this therapy area.
Adam Hill
Related Content
FDA approves Janssen’s Xarelto for blood clot prevention
Janssen’s Xarelto (rivaroxaban) has secured FDA approval for the prevention of venous thromboembolism (VTE), or …
Bayer’s Xarelto combo greenlighted by NICE for reducing CV events in artery disease
NICE has awarded final appraisal recommendation to Bayer’s Xarelto (rivaroxaban) at a dosage of 2.5mg …
Boehringer’s Pradaxa fails to meet Phase 3 endpoint in preventing recurrent stroke
Boehringer has announced that Pradaxa (dabigatran etexilate mesylate) has failed to meet its primary endpoint …
