April 7th, 2014
Boehringer Ingelheim announced on Monday that the FDA has approved dabigatran (Pradaxa) for the treatment of venous thromboembolism (VTE), which includes both deep venous thrombosis (DVT) and pulmonary embolism (PE), and to reduce the risk of recurrent DVT and PE in patients who have been previously treated. All three of the new oral anticoagulants — dabigatran, rivaroxaban (Xarelto), […]
March 14th, 2014
The FDA has approved a new indication for apixaban (Eliquis), the anticoagulant drug manufactured by Bristol-Myers Squibb and Pfizer. The new indication is for the prophylaxis of deep vein thrombosis (DVT) and pulmonary embolism in patients who have undergone hip or knee replacement surgery. The DVT prophylaxis indication joins the previously approved indication of stroke prevention in patients who have […]
December 5th, 2013
A very large new meta-analysis finds a favorable risk-benefit for the new oral anticoagulant drugs in the setting of atrial fibrillation. The findings, published online in the Lancet, were remarkably consistent for all four of the new agents which have been fighting to replace warfarin, which was the only oral anticoagulant available for decades until the arrival of […]
September 16th, 2013
This week’s topics include the AMPLIFY trial, D2B time and mortality among those undergoing primary PCI, and more.
July 1st, 2013
In a large clinical trial the new oral anticoagulant apixaban (Eliquis, Pfizer and Bristol-Myers Squibb) was at least as effective as standard therapy and caused fewer bleeding complications in patients with acute venous thromboembolism (VTE). The results of the AMPLIFY (Apixaban for the Initial Management of Pulmonary Embolism and Deep-Vein Thrombosis as First-Line Therapy) trial are being presented today at […]
June 24th, 2013
After the presentation and publication of the pivotal ARISTOTLE trial, the novel anticoagulant apixaban (Eliquis, Pfizer and Bristol-Myers Squibb) was widely expected to be a blockbuster. But then it got bogged down at the FDA where initial hopes for a speedy approval were dashed after highly critical reviews. Approval of the drug was delayed for 9 months […]
February 25th, 2013
This week’s topics include extended use of apixaban, dabigatran, warfarin, or placebo in VTE, the 5-year follow-up of the SYNTAX study, and more.
February 20th, 2013
Three studies published in the New England Journal of Medicine provide important new information about the risks and benefits of extended prophylaxis using two of the new oral anticoagulants in patients who have had venous thromboembolism (VTE). In the RE-MEDY and the RE-SONATE trials, the role of dabigatran was examined in patients who had completed at least 3 months […]
January 17th, 2013
Two experts discuss the evolving landscape of novel anticoagulants for patients with AF. Do you agree with their perspectives? What questions do you have? What has your experience taught you?
December 28th, 2012
The FDA has finally approved apixaban (Eliquis, Bristol-Myers Squibb and Pfizer) to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation (AF). The action comes after the widely-anticipated drug had been plagued by delays at the FDA but well before the PDUFA deadline of March 17, 2013. Eliquis is the latest member […]