New Kids on the Block

As New Anticoagulants Seek to Replace Warfarin, Hospitalists Need to Know All the Facts Before Making Therapy Decisions

Thomas R. Collins; Robert Pendleton, MD; Geno Merli, MD, FHM; Gregory Maynard, MD, MSc, SFHM

Disclosures

The Hospitalist. 2011;15(6):1, 29-30, 32-33. 

In This Article

New Options, New Challenges, New Costs

Dabigatran, which inhibits thrombin, is part of a new anticoagulant parade, along with rivaroxaban (Xarelto) and apixaban, both of which inhibit Factor Xa. They offer patients attractive anticoagulant options that, unlike warfarin, don't require blood draws for monitoring every few weeks. The new options also omit the lengthy list of drug and food contraindications of warfarin.

But questions about the ability to reverse bleeds while patients are on the new drugs, as well as concerns about their costs, are forcing hospitalists to evaluate carefully. So far, dabigatran is the only one approved in the U.S., and only for one indication.

The intention in development was to create "drugs that don't require monitoring, drugs that have very little drug-drug interaction, and drugs that have no food interaction; a drug where you give a fixed dose and the patients get the same effect anticoagulation-wise," says Geno Merli, MD, FHM, director of the Jefferson Center for Vascular Disease and CMO at Thomas Jefferson University Hospital in Philadelphia. "When you look at the studies, actually they do reasonably well. It's a pretty big step." (For a list of major anticoagulant studies, see Figure 1, right.)

Figure 1.

Major Studies on Potential Anticoagulant Successors to Warfarin

Rivaroxaban, being developed jointly by Bayer Healthcare and Johnson & Johnson, has been submitted to the FDA for approval for stroke prevention in nonvalvular atrial fibrillation patients, which would put it in direct competition with dabigatran. And apixaban, being developed by Bristol-Myers Squibb, expects to submit for the same indication approval this year, company spokeswoman Christina Trank says.

All three are under study for other indications, including VTE prevention after hip and knee replacement surgeries, and clot prevention in the acutely ill.

Thestakes are high for the companies: Manufacturers and analysts estimate that the market for anticoagulants will top $10 billion by 2015, with some estimates even higher. Dabigatran has been in development by Boehringer for about 15 years and studied in more than 19,000 patients, spokeswoman Anna Moses says.

Bayer Healthcare says rivaroxaban's development costs amount to more than $1.5 billion.

"I think all of them are promising," says Shaun Mickus, a Johnson & Johnson spokesman. "We're looking at meeting unmet medical needs. We have patients who, for one reason or another, are having blood clots in these indicated areas, and some of them are doing fine and getting the help they need, and others may not be."

Boehringer spokeswoman Anna Moses said dabigatran is on formulary with 70% of the top 1,600 hospitals in the U.S.

"Our current focus is on efforts to educate physicians and payors about the product, including its efficacy, safety, and appropriate use," Moses said in an email.

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