Registry analysis shows atrial fib patients who take dabigatran etexilate have low risk of stroke, bleeding

A registry analysis found that patients with non-valvular atrial fibrillation who received dabigatran etexilate (Pradaxa) had low rates of stroke, major bleeding and life-threatening bleeding after two years of treatment.

The results were presented in a late-breaking session at the European Society of Cardiology (ESC) Congress in Rome on Aug. 29.

The analysis evaluated real-world data from 2,932 patients who were newly diagnosed with non-valvular atrial fibrillation and enrolled in the GLORIA-AF registry.

At two years, 0.63 percent of patients treated with dabigatran etexilate had a stroke, 0.54 percent had life-threatening bleeding and 1.12 percent had major bleeding.

Dabigatran etexilate, an oral direct thrombin inhibitor, is FDA-approved to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation.

Boehringer Ingelheim, the manufacturer of dabigatran etexilate, said in a news release that the company plans on enrolling up to 56,000 patients in the ongoing GLORIA-AF registry at 2,200 sites in 50 countries. As of late August, 34,500 patients had enrolled.

“Practice-based studies such as the GLORIA-AF Registry complement clinical trials by including larger, more diverse patient populations with the comorbidities encountered in various medical settings,” study researcher Jonathan L. Halperin, MD, of the Icahn School of Medicine at Mount Sinai in New York, said in a news release. “These interim findings from GLORIA-AF are consistent with the results of the randomized RE-LY trial and previous population-based studies, including a U.S. Food and Drug Administration analysis of more than 134,000 Medicare recipients. Taken together, these data reinforce the favorable risk-benefit profile of dabigatran in routine care of patients with atrial fibrillation.”