November 27th, 2012
Longer Warfarin Therapy After Bioprosthetic Aortic Valve Replacement May Be Beneficial
Larry Husten, PHD
Three months of warfarin is the usual standard of care following bioprosthetic aortic valve replacement (AVR), although the supporting evidence base for this practice is limited. A new, large registry study published in JAMA suggests that more-prolonged warfarin therapy may be beneficial. Danish researchers identified 4075 patients who underwent bioprosthetic AVR. As expected, warfarin treatment between 30 and […]
November 15th, 2012
In Acute VTE, Novel Oral Anticoagulants and Conventional Therapy Show Similar Efficacy
Nicholas Downing, MD
Novel oral anticoagulants and vitamin K antagonists offer similar protection against venous thromboembolism recurrence, according to a BMJ meta-analysis. However, one of the newer agents, rivaroxaban, seems to offer better protection against bleeding. The analysis included nine randomized controlled trials comparing apixaban, dabigatran, rivaroxaban, or ximelagatran (no longer on the market) with traditional vitamin K antagonists […]
November 4th, 2012
ASPIRE: Aspirin an Attractive Alternative After First VTE
Larry Husten, PHD
It is unclear what the best approach is for the long-term treatment of people who have had a first unprovoked episode of venous thromboembolism (VTE). Although warfarin is effective at preventing a recurrence, it is inconvenient and raises the risk for bleeding. Newer anticoagulants have not been tested or approved for this population. The ASPIRE (Aspirin […]
November 3rd, 2012
Rivaroxaban Gains FDA Indications for Treating and Preventing DVT and PE
Larry Husten, PHD
The FDA has expanded the indication for rivaroxaban (Xarelto, Johnson & Johnson) to include the treatment of deep-vein thrombosis (DVT) and pulmonary embolism (PE) and to reduce the risk for recurrent DVT and PE. The oral anticoagulant is already approved to reduce postsurgical risk for DVT and PE after hip- and knee-replacement surgery and to reduce […]
November 2nd, 2012
FDA Investigation Finds No Excess Bleeding Risk for Dabigatran
Larry Husten, PHD
In its latest assessment of a highly controversial issue, the FDA has found no indication that bleeding rates for dabigatran (Pradaxa, Boehringer-Ingelheim) are any higher than the bleeding rates for warfarin. The FDA investigation was in response to the large number of post-marketing reports of bleeding in people taking dabigatran. Click here to for the full FDA […]
October 23rd, 2012
Setback for Trial Studying Dabigatran After Mechanical Valve Surgery
Larry Husten, PHD
Despite the recent advent of novel oral anticoagulants, the much-maligned warfarin remains the only current option available for patients who have received a mechanical valve. Now the first trial to explore this indication for a newer oral anticoagulant has suffered a setback. Last year, Boehringer Ingelheim announced the launch of the RE-ALIGN trial, a phase 2, […]
October 23rd, 2012
High Rate of Warfarin Discontinuation Observed in Study
Larry Husten, PHD
One of the many potential problems with warfarin-based anticoagulant therapy is the poor rate of adherence and persistence among patients who are prescribed the drug. Now an observational study published in the Archives of Internal Medicine raises the possibility that the problem may be even worse than many have suspected, as discontinuation rates in clinical trials appear […]
October 15th, 2012
Stable Anticoagulation, Unstable Gait
Jeff Dickey, MD and James Fang, MD
A 91-year-old man with mild drug-controlled hypertension and atrial fibrillation has long-term, well-managed stability on warfarin anticoagulation. After developing problems with his balance and some gait instability, a physical exam reveals a carotid bruit. Carotid ultrasound and magnetic resonance angiography (MRA) confirm >95% stenosis of the right internal carotid artery. Brain CT is negative. Questions: 1. […]
October 8th, 2012
Triple Antithrombotic Therapy: What — and When — Is the Bleeding Risk?
Morten Lamberts, MD and John Ryan, MD
Morten Lamberts, MD, lead investigator of a recent registry study of various combinations of antithrombotic agents in patients with AF and CAD, answers John Ryan’s questions about the study and its implications.
September 27th, 2012
FDA Sets New Decision Date for Eliquis (Apixaban)
Larry Husten, PHD
The FDA will decide the fate of apixaban (Eliquis) by March 17, 2013. The new Prescription Drug User Fee Act (PDUFA) goal date was announced yesterday by the drug’s manufacturers, Pfizer and Bristol-Myers Squibb. The new drug application (NDA) for apixaban for stroke prevention in atrial fibrillation has been delayed twice. Although the pivotal ARISTOTLE trial was highly praised when […]