A pair of new studies suggest that dabigatran etexilate (Pradaxa), the first new oral anticoagulant approved in 56 years, increases the risk of myocardial infarction (MI) and acute coronary syndrome (ACS) in patients. But the author of one of the reports says the drug's benefits may be worth the risks.
"Yes, there's an increase, but that tends to be the headline," says Ken Uchino, MD, FAHA, program director of the Vascular Neurology Fellowship at the Cleveland Clinic's Cerebrovascular Center. "We have to think about the benefits and the risk balance. So far, it is favorable."
Dr. Uchino and a colleague's meta-analysis, "Dabigatran Association with Higher Risk of Acute Coronary Events," was published last month on the Archives of Internal Medicine's website. The report found dabigatran, which was approved last year, was significantly associated with a higher risk of MI or ACS when measured against multiple control groups.
A separate study, "Myocardial Ischemic Events in Patients with Atrial Fibrillation Treated with Dabigatran or Warfarin in the RE-LY Trial," published on Circulation's website, reported a nonsignificant increase in MI with dabigatran compared with warfarin, but other myocardial ischemic events were not increased.
Both reports come as the FDA evaluates post-marketing reports of serious bleeds in patients taking the drug.
Dr. Uchino believes that, taken together, the two studies are important, but more research would need to be completed to sway public opinion on whether dabigatran and other new anticoagulation therapies can unseat warfarin as the go-to treatment.
"Warfarin is such a cumbersome medication, we have all been waiting for a new medication," he adds. "So there are clear advantages to dabigatran and other newer anticoagulants. ... Our study puts us at a caution, but we should continue to gather data and continue to assess risk and benefits."