The FDA’s approval of a new oral anticoagulant—the first in 56 years—has sparked conversation in internal-medicine circles, prompting the industry to wonder: Will the new drug unseat warfarin as the go-to therapy?
Warfarin is among the most common prescriptions written by hospitalists, but that is in part due to its status as the lone option for the prevention of strokes and embolisms in atrial fibrillation (AF) patients. But on Oct. 19, the FDA approved dabigatran etexilate (Pradaxa) for AF patients. Several other similar medications are under development.
An FDA announcement on the approval notes that in a trial of 18,000 patients, those taking dabigatran etexilate had fewer strokes than those who took warfarin. The study (N Engl J Med. 361;12:1139-1151) reported primary outcome rates were 1.69% per year in the warfarin group, compared with 1.53% per year in the group that received 110mg of dabigatran (P<0.001).
Marketers for the new drug have suggested that while physicians often are slow to accept new therapies, the elimination of blood monitoring that often increases length of stay could nudge hospitalists to adopt the treatment more quickly.
Kurt Pfeifer, MD, FACP, program director of the Internal Medicine Residency program at Medical College in Milwaukee and a bleeding-risk research follower, is not so sure. He says that until there is clinical evidence, it will be difficult to tout any potential long-term benefits of the new therapy.
“It’s not time to have a funeral for warfarin,” Dr. Pfeifer says.
He adds that dabigatran’s initial trials have not showed him such a compelling efficacy that he would consider removing current warfarin patients from their therapy. He also says that the cost of the new medication—at least double that of warfarin, with no generics available—will be a stumbling block and could prevent it from hospital formularies.
“Even with all these alternative anticoagulants out there, there is still no doubt that warfarin will be a mainstay therapy,” Dr. Pfeifer says. “There is a reason these drugs are around a long time. …They are effective and they are cheap.”