FDA Grants New Indication For Apixaban Reply

The FDA today approved an expanded indication for  the oral anticoagulant apixaban (Eliquis, Bristol-Myers Squibb and Pfizer). Apixaban will now be indicated for the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE), and for the reduction in the risk of recurrent DVT and PE (collectively known as venous thromboembolism) after initial therapy.

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New Trial Confirms Role For Pradaxa In Venous Thromboembolism Reply

A new study helps support a role for  the new oral anticoagulant dabigatran (Pradaxa, Boehringer Ingelheim) in patients with venous thrombosis (VTE).  The RE-COVER II trial, published online in Circulation, confirms the finding of the earlier and highly similar RE-COVER trial, published in the New England Journal of Medicine in 2009, that dabigatran is as safe and effective as warfarin for the treatment of  deep vein thrombosis (DVT) and pulmonary embolism (PE). Dabigatran is currently approved only for the treatment of stroke prevention in patients with non-valvular atrial fibrillation.

In RE-COVER II 2,589 patients with acute VTE were  randomized to dabigatran or warfarin following standard heparin treatment for 5 to 11 days. At 6 months the rate of recurrent VTE and related deaths was 2.3% in the dabigatran group versus 2.2% in the warfarin group (HR 1.08, CI 0.64 – 1.80; p<0.001 for noninferiority). There were no significant differences in the incidence of deaths, adverse events, and acute coronary syndromes.

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Pradaxa

Positive Results for New Anticoagulant From Daiichi Sankyo Reply

A new entrant in the growing oral anticoagulant field shows promise for the treatment of venous thromboembolism (VTE) and pulmonary embolism (PE). The drug, edoxaban, is a new, once-daily Factor Xa inhibitor with a rapid onset of action that is under development by Daiichi Sankyo. Results of the Hokusai-VTE trial were presented at the European Society of Cardiology meeting in Amsterdam and published simultaneously in the New England Journal of Medicine.

The Hokusai-VTE investigators randomized 4921 patients with VTE and 3319 patients with PE to either warfarin or edoxaban. The trial differed from some earlier trials with new oral anticoagulants in that patients were treated following a lead-in period with heparin. In addition, patients were treated for as short as three months or as long as a year at the discretion of the physician, though patients were followed for a full year. Patients with low body weight or renal impairment received a half dose of edoxaban. The investigators said the design was intended to reflect the full spectrum of conditions clinicians see in real life.

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Vena Cava Filters: Little Evidence And Wide Variation In Use Reply

Despite the absence of any evidence demonstrating benefit or showing how best to use them, vena cava filters (VCF) are used in most hospitals. Now a new study published in JAMA Internal Medicine suggests that this same lack of evidence results in an extremely broad rate of use in different hospitals. An accompanying viewpoint raises the question: “how could a medical device be so well accepted without any evidence of efficacy?”

Researchers conducted a retrospective observational study that compared the frequency of VCF use in 236 California hospitals by analyzing data from 130,643 acute VTE hospitalizations over four years. Overall, the rate of VCF placement was 14.95%, but there was a very broad variation in the percentage of acute VTE cases in which a VCF was placed, from 0% to 38.96%. The authors said that this finding places VCF “among surgical procedures with the greatest variation in geographic studies in the United States.” Even after adjusting for differences in patient populations between hospitals, the variation between hospitals remained significant.

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English: Taken by user:BozMo URL at http://cat...

English: Taken by user:BozMo URL at http://catesfamily.org.uk Picture of used inferior vena cava filter, showing the hook at top for removal via Jugular Vein, the umbrella structure and the leg spikes to fix in place. (Photo credit: Wikipedia)

New Studies Examine Prolonged Anticoagulation For VTE Recurrence Reply

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 an accompanying editorial, Jean Connors writes that “deciding how to balance the risks and benefits of extended anticoagulation is difficult” in patients with unprovoked VTE, since the risk of recurrent VTE may reach 40% at 5 years. Patients at low-to-moderate risk of recurrence may benefit from aspirin, which “may be safer than the newer agents,” though “it appears to have less efficacy in reducing recurrent events.” For patients at higher risk, “the new targeted anticoagulants are attractive alternatives to warfarin. The finding that a low prophylactic dose of apixaban has the same efficacy as the full therapeutic dose, with no increased risk of major bleeding, may tip the risk-to-benefit ratio in favor of extended treatment for this patient population. The wide therapeutic window of this agent enables use of a lower dose that retains great efficacy with no or only a minimal increase in bleeding.”

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The New England Journal of Medicine

 

 

 

Rivaroxaban Effective In Medically Ill Patients But At High Bleeding Cost Reply

The recent arrival of novel oral anticoagulants has provided important new options for venous thromboembolism (VTE) treatment and prevention. New indications for these drugs have been granted for patients with atrial fibrillation and following orthopedic surgery. But an additional indication, for acutely ill medical patients at risk for VTE, does not appear likely in the near future, as a new trial published in the New England Journal of Medicine shows that one of these novel drugs, though effective at preventing VTE, also resulted in a significant increase in bleeding risk.

In the Multicenter, Randomized, Parallel Group Efficacy and Safety Study for the Prevention of Venous Thromboembolism in Hospitalized Acutely Ill Medical Patients Comparing Rivaroxaban with Enoxaparin (MAGELLAN), first presented at the American College of Cardiology meeting in 2011, more than 8,000 medically ill patients were randomized to subcutaneous enoxaparin for 1o days or oral rivaroxaban for 35 days.

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ASPIRE: Aspirin An Attractive Alternative After First VTE Reply

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 to Prevent Recurrent Venous Thromboembolism) trial randomized 822 patients who had finished an initial course of anticoagulant therapy after a first unprovoked case of VTE to either aspirin (100 mg daily) or placebo for 4 years. Although the reduction in the rate for recurrent VTE with aspirin did not reach statistical significance, there were significant reductions in secondary outcomes of clinical events:

26% reduction in the yearly rate of VTE recurrence (primary endpoint):

  • 6.5% for placebo and 4.8% for aspirin (HR 0.74, CI 0.52-1.05, p=0.09)

34% reduction in the yearly rate of major vascular events (VTE, MI, stroke, or CV death):

  • 8.0% versus 5.2% (HR 0.66, CI 0.48-0.92, p=0.01)

33% reduction in the yearly rate of VTE, MI, stroke, major bleeding, or all-cause mortality (net clinical benefit):

  • 9.0% versus 6.0% (HR 0.67, CI 0.49-0.91, p=0.01)

The ASPIRE investigators calculated that for every 1000 patients treated for 1 year, aspirin would prevent 17 episodes of VTE and 28 major thrombotic events, at a cost of 5 nonfatal bleeding episodes.

Reporting in the New England Journal of Medicine, the investigators write that although aspirin is “substantially less effective than warfarin,” it is “an attractive alternative because it is simple and inexpensive and its safety profile is well documented.”

In an accompanying editorial, Theodore Warkentin combined the ASPIRE results with findings from the recent WARFASA trial and calculated that aspirin results in a 32% reduction in the rate of recurrent VTE and a 34% reduction in the rate of major vascular events. He concludes that aspirin is “a reasonable option” for patients who wish to stop anticoagulation:

Aspirin is inexpensive, does not require monitoring (in contrast to warfarin), and does not accumulate in patients with renal insufficiency (in contrast to dabigatran and rivaroxaban); in addition, if major bleeding occurs or the patient requires urgent surgery, the antiplatelet effects of aspirin can be reversed…”

Aspirin Found To Prevent Recurrent Venous Thromboembolism 1

Aspirin can help prevent the recurrence of venous thromboembolism (VTE) after discontinuation of anticoagulation therapy, according to results of the WARFASA (the Warfarin and Aspirin) study published in the New England Journal of Medicine.

Following 6 to 18 months of oral anticoagulation, 403 patients with first-time unprovoked VTE were randomized to aspirin (100 mg daily) or placebo for two years. Aspirin therapy resulted in a significant reduction in VTE but did not cause an increase in the risk of bleeding:

  • VTE recurrence: 6.6% per year in the aspirin group versus 11.2% in the placebo group (hazard ratio 0.58, CI 0.36 to 0.93, p=0.02).
  • Major bleeding occurred in one patient in each treatment group.

In an accompanying editorial, Richard Becker writes that the results of WARFASA “are compelling and may signal an important step in the evolution of care” but calls for additional studies to more precisely define the role of aspirin in preventing recurrent VTE. The results of a larger trial, the Aspirin to Prevent Recurrent Venous Thromboembolism (ASPIRE) study, will be reported this year, according to Becker, and, in conjunction with WARFASA, “may provide more reliable evidence of the effect of aspirin in patients with first unprovoked venous thromboembolism.”