THURSDAY, May 16, 2019 (Pharmacist's Briefing) -- Dabigatran is not superior to aspirin for preventing recurrent stroke in patients with recent history of embolic stroke of undetermined source, according to a study published in the May 16 issue of the New England Journal of Medicine.
Hans-Christoph Diener, M.D., Ph.D., from the University Duisburg-Essen in Germany, and colleagues conducted a multicenter, randomized, double-blind trial of dabigatran at 150 mg or 110 mg twice daily versus aspirin at 100 mg once daily among patients with embolic stroke of undetermined source. Data were included for 5,390 patients enrolled at 564 sites and randomly assigned to dabigatran (2,695 patients) or aspirin (2,695 patients).
The researchers found that recurrent strokes occurred in 6.6 and 7.7 percent of patients in the dabigatran and aspirin groups, respectively, during a median follow-up of 19 months (4.1 and 4.8 percent per year, respectively; hazard ratio, 0.85; 95 percent confidence interval, 0.69 to 1.03; P = 0.10). Ischemic strokes occurred at a rate of 4.0 and 4.7 percent per year, respectively (hazard ratio, 0.84; 95 percent confidence interval, 0.68 to 1.03). Major bleeding occurred at a rate of 1.7 and 1.4 percent per year, respectively (hazard ratio, 1.19; 95 percent confidence interval, 0.85 to 1.66).
"Post hoc analysis suggested that dabigatran may have had an effect on stroke recurrence after one year, but no inferences can be made because of the post hoc nature of the analysis," the authors write.
Several authors disclosed financial ties to pharmaceutical companies, including Boehringer Ingelheim, which manufactures dabigatran and supported the study.