This article is more than 5 years old. Information may no longer be current.
Dabigatran performed as well as warfarin in treating AF
Click Here to Manage Email Alerts
In everyday clinical practice, dabigatran appears to be as safe as warfarin for the treatment of atrial fibrillation, researchers reported in the Journal of the American College of Cardiology.
A team of researchers assessed the safety and efficacy of dabigatran (Pradaxa, Boehringer Ingelheim) in everyday practice after post-approval availability in Denmark as compared with warfarin. The study focused on anticoagulant-naive patients with AF (43.5% women; mean age, 70.8 years). Using the Danish Registry of Medicinal Product Statistics, the researchers identified 4,978 dabigatran-treated patients and 8,936 warfarin-treated patients (1:2 propensity matched). The dabigatran group was further divided by dosage: 110 mg twice daily (n=2,739) and 150 mg twice daily (n=2,239).
The researchers found no significant difference in stroke and systemic embolism between the dabigatran and warfarin groups, and a lower incidence of pulmonary embolism with dabigatran.
Mortality was significantly lower with 110 mg dabigatran (propensity-match group stratified HR [aHR]=0.79; 95% CI, 0.65-0.95) and 150 mg dabigatran (aHR=0.57; 95% CI, 0.4-0.8) vs. warfarin.
In contrast with concerns previously raised, the researchers found no evidence of excess bleeding events or MI among dabigatrain-treated patients, even in a subgroup of patients with at least a year of follow-up. Major bleeding events were comparable across all groups (P=.21). Both dabigatran doses were associated with lower intracranial bleeding rates vs. warfarin (110 mg aHR=0.24; 95% CI, 0.08-0.56; 150 mg aHR=0.08; 95% CI, 0.01-0.4). Gastrointestinal bleeding was lower with the 110-mg dose (aHR=0.6; 95% CI, 0.37-0.93) but not the 150-mg dose vs. warfarin. The incidence of MI was low overall and lower with both dabigatran doses (110 mg aHR=0.3; 95% CI, 0.18-0.49; 150 mg aHR=0.4; 95% CI, 0.21-0.7) vs. warfarin.
Disclosure: The study was conducted fully independent of any industry or other grant support. See the study for a full list of the researchers’ relevant financial disclosures.
Click Here to Manage Email Alerts