Drug Safety
-
Non-valvular atrial fibrillation (NVAF) is the most common clinically significant cardiac arrhythmia and is a common cause of stroke. The direct thrombin inhibitor dabigatran etexilate is approved for a variety of indications requiring anticoagulation, including stroke prevention in NVAF. Dabigatran does not require routine monitoring and exhibits only a few drug-drug interactions; however, impaired renal function needs observation. ⋯ Pharmacovigilance sources prove the anticipated bleeding risk, but a refined analysis of such data showed that bleeding rates associated with dabigatran use did not appear to be higher than those associated with warfarin. Dabigatran confers an advantage over warfarin regarding stoke prevention without the burden of the surveillance of vitamin K antagonists, especially in patients with high stroke risk. However, in elderly patients with impaired renal function or considerable bleeding risks, label advice regarding dosing needs strict observation.