Dabigatran: Clinical correlation of drug and its dose with risk of stroke and bleeding.

Background: Dabigatran is the first oral direct thrombin inhibitor which is endorsed by Food and Drug Administration in the prevention of embolic events in patients with nonvalvular atrial fibrillation. Suitable dose of the drug for the patient is selected based on CHA2DS2-VASc score and HAS-BLED score.

Aim: To determine and compare the risk of occurrence of stroke and bleeding after the initiation of dabigatran therapy in patients prescribed with this drug.

Methods: Patients with more than 18 years who were prescribed with dabigatran during 2017-2019 in a tertiary care hospital were selected for the study. Most of the patient's prescriptions contained an antiplatelet, so a comparison was made between the clinical outcomes of patients given with dabigatran alone and dabigatran with an antiplatelet because antiplatelet can have effects on the safety as well as efficacy profile of dabigatran.

Results: Out of 75 patients enrolled in the study, 42 patients were in the dabigatran with the antiplatelet group and 33 were in the dabigatran alone group. In both the groups, there was a significant reduction in CHA₂DS₂-VASc score, i.e., 2.58 ± 1.32-1.94 ± 1.21 in dabigatran-treated patients within 6 months, and the score was lowered from 3.76 ± 1.22 to 2.92 ± 1.22 in other groups. The mean value of the HAS-BLED score of dabigatran was reduced from 1.15 ± 0.83 to 0.84 ± 0.78 and that of dabigatran with antiplatelet group from 2.10 ± 0.94 to 1.74 ± 0.92.

Conclusion: It was observed that within 6 months, both the treatment groups showed a reduction in the risk scores. The dabigatran group had lower background risks of stroke and bleeding in comparison to the dabigatran plus antiplatelet group.