Stroke, Major Bleeding Risk Low with Dabigatran Etexilate
WASHINGTON, DC—At the ACC.17 Scientific Session, study authors presented data which showed that the rates of stroke and major bleeding were low with dabigatran etexilate 110mg or 150mg twice daily doses, emphasizing the long-term safety and efficacy in routine practice.
Christine Teutsch, from Boehringer Ingelheim, Ingelheim, Germany, and coauthors reported 2-year clinical outcomes for patients with nonvalvular atrial fibrillation from the GLORIA-AF registry who received dabigatran etexilate 150mg twice daily or dabigatran etexilate 110mg twice daily.
The data represents ~3,000 patients who had received the study drug in Phase 3 of GLORIA-AF with up to 2 years follow-up: dabigatran 150mg twice daily (n=1,748) and dabigatran 110mg twice daily (n=1,106). Study patients received dabigatran etexilate for a mean of 17.9 months.
When compared with dabigatran etexilate 110mg, patients in the dabigatran etexilate 150mg group were younger (median age 67 vs. 75), had lower CHA2DS2VASc scores (mean 2.9 vs. 3.7), and less comorbidities (eg, myocardial infarction, heart failure).
For the dabigatran etexilate 150mg group, the rate of stroke was 0.56 (95% CI: 0.30, 0.94) per 100 patient-years and the rate of major bleeding was 1.00 (95% CI: 0.64, 1.47) per 100 patient-years. For the dabigatran etexilate 110mg group, the rate of stroke was 0.67 (95% CI: 0.33, 1.20) per patient-years and the rate of major bleeding was 1.16 (95% CI: 0.70, 1.80) per 100 patient-years.
The rate of myocardial infarction was slightly higher in the dabigatran etexilate 150mg group vs. dabigatran etexilate 110mg group (0.48 per 100 patient-years vs. 0.43 per 100 patient-years). The incidence of all-cause mortality was higher in the dabigatran etexilate 110mg group vs. the dabigatran etexilate 150mg group (3.16 per 100 patient-years vs. 2.07 per 100 patient-years).
"Consistent with observations from other registry and database studies, rates of stroke and major bleeding were low with both dabigatran etexilate doses, highlighting their long-term safety and effectiveness in routine clinical practice," concluded Teutsch.