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Anticoagulation
Exanta only Cost Effective for High Risk Patients
A new study raises questions about the cost effectiveness, benefits, and risks of a new anti-clotting drug. The drug, sold as Exanta, is a potential replacement for warfarin, which can, among other things, prevent stroke in people with the heartbeat abnormality known as atrial fibrillation. While warfarin prescribed it is also notoriously difficult to manage, requires frequent blood tests to monitor clotting levels, and has adverse reactions with a number of other drugs.
Exanta has none of those problems. However, the U.S. Food and Drug Administration (FDA) has not approved its use in this country, and several European countries have approved the drug only for limited purposes, because some people who take it experience increases in levels of an enzyme associated with liver damage.
The study compared Exanta with warfarin in 3,922 people with atrial fibrillation and other risk factors for stroke. The American researchers found the incidence of stroke was slightly higher for those who took Exanta -- 1.6 percent per year, compared to 1.2 percent for those who took warfarin. There was no difference in the incidence of major bleeding episodes, but the overall incidence of bleeding episodes was about a third lower for those who took Exanta.
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However, levels of enzymes indicating possible liver damage rose to greater than three times the normal limit in 6 percent of patients taking Exanta, usually within six months, although those levels typically declined whether or not Exanta treatment continued.Because doctors often hesitate to prescribe warfarin because of difficulties it presents, approval of Exanta could help many patients with atrial fibrillation.
Further clinical trials are unlikely to settle the issue because Exanta has already been tested in trials including more than 18,000 people. The present analysis shows that in terms of dollars and cents, substituting Exanta for warfarin would not be cost-effective for people with atrial fibrillation who have a low risk of bleeding complications. But it could be effective for patients who now are given aspirin to prevent clots because they have a high risk of bleeding complications if given warfarin.
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