An anticoagulant approved for patients with the abnormal heart rhythm atrial fibrillation (AF) also may get the green light from the FDA for acute venous thromboembolism (VTE) prevention.
Dabigatran (Pradaxa) — recently OK’d by the Food and Drug Administration to help lower the risk of stroke and systemic embolism in AF patients — might soon become authorized as an alternative to warfarin (Coumadin) to lower the risk of VTE, based on successful trials. VTE is when a blood clot forms in one of the body’s deep veins and it travels to the lungs.
Delays in the ability to diagnose and treat VTE account for a substantial number of instances of morbidity and mortality, according to the American Thoracic Society (ATS). While there are up to 260,000 patients in the United States diagnosed with VTE annually, it is believed that an estimated 600,000 to 1,000,000 cases actually occur, about half going undetected, the ATS says.
Warfarin vs. dabigatran
The downsides of warfarin, according to John Bartholomew, MD, Section Head of Vascular Medicine at Cleveland Clinic, include food and drug interactions, and needing to have your blood checked frequently. Those are not issues with dabigatran, he says.
“Dabigatran offers a much more predictable response,” he says. “So if a patient doesn’t live near a Coumadin clinic and can’t get to a hospital easily for those blood checks, dabigatran might be a good alternative.”
Dr. Bartholomew cautions that there still are some questions surrounding the use of dabigatran, as dabigatran has not been thoroughly evaluated during pregnancy nor patients with liver or kidney disease.
Drawbacks to dabigatran include the expense compared to warfarin and the requirement of two doses per day, where warfarin only involves one daily pill. The cost may be offset somewhat because dabigatran does not require monitoring.
In addition, the only known drug interaction involving dabigatran that merits consideration has to do with rifampin, an antibiotic. Warfarin is known to have many drug interactions, including with clopidogrel and non-steroidal anti-inflammatory drugs (NSAIDS) like aspirin.
Consult your doctor
When taking into account the two options, Dr. Bartholomew advises AF patients to consult their doctor about the pros and cons of making the switch, especially when it comes to those prone to bleeding episodes. He notes that there is no antidote for bleeding related to the drug.
Another warfarin alternative has emerged for AF patients, based on a recently completed trial comparing its performance with that of rivaroxaban. Fewer AF patients taking the drug — up for FDA approval this year — had blood clots or strokes than those taking warfarin.