Dabigatran versus Vitamin K Antagonists in Non-Asian Patients with Atrial Fibrillation

A meta-analysis of “real–world” studies, led by Carlos Escobar, MD, PhD, from the Servicio de Cardiología at the Hospital Universitario La Paz in Madrid, Spain, found that dabigatran improved efficacy and safety outcomes when compared to vitamin K antagonists in non–Asian patients with non–valvular atrial fibrillation (AF). The report was published in Clinical Drug Investigation.


The study designers reviewed 37 articles encompassing 1,600,722 participants (446,439 treated with dabigatran and 1,154,283 with vitamin K antagonists) to evaluate dabigatran both globally and stratified by dose (110 or 150 mg twice daily).


Dr. Escobar reported that dabigatran 150 mg reduced the risk of ischemic stroke by 14% compared with vitamin K antagonists (hazard ratio [HR] = 0.86, 95% confidence interval [CI] 0.74–0.98). Globally, dabigatran reduced the risk of all-cause mortality relative to vitamin K antagonists (HR = 0.76, 95% CI 0.69–0.84), especially in the 150 mg dose (HR = 0.65, 95% CI 0.58–0.73). Further, risk of myocardial infarction trended lower with dabigatran 150 mg (HR = 0.86, 95% CI 0.71–1.04).


Regarding primary safety measures, the article stated that dabigatran, at either dose, resulted in reduced risk of major bleeding (HR = 0.77, 95% CI 0.70–0.83), intracranial bleeding (HR = 0.44, 95% CI 0.39–0.50), and fatal bleeding (HR = 0.76, 95% CI 0.60–0.95) compared with vitamin K antagonists.


Authors did note that dabigatran treatment was associated with a slight increase in the risk of gastrointestinal bleeding (HR = 1.16, 95% CI 1.08–1.26), but they still attributed favorable improvements for patients with AF to the drug, supporting its value in real–world use.