Dabigatran etexilate in atrial fibrillation.

Atrial fibrillation (AF) affects millions worldwide. Stroke is the most devastating complication of AF and is associated with a huge disease burden. As a preventive measure, anticoagulant therapy is recommended for most AF patients based on presence of stroke risk factors. For the past six decades warfarin remained the gold standard for stroke prevention in AF (SPAF). However, it is associated with numerous limitations such as a high risk of drug-drug, drug-food interactions and need for frequent INR (2-3) monitoring. Novel oral anticoagulant (NOAC) dabigatran etexilate is a selective, specific, reversible direct thrombin inhibitor that has been approved in India for SPAF and primary venous thromboembolism prevention. The efficacy and safety of dabigatran in AF has been established the "Randomized Evaluation of Long-Term Anticoagulant Therapy (RE-LY)", a randomized clinical trial. RE-LY (n = 18,113) demonstrated that the efficacy of dabigatran 110 mg BID was as good as well controlled warfarin and dabigatran 150 mg BID reduced the risk of ischaemic stroke by 25% (P = 0.03). Till date, 150mg dabigatran is the only NOAC offering a superior reduction in most commonly seen ischemic strokes due to AF compared to warfarin. Additionally, both doses of dabigatran significantly reduced the risk of total bleeds, intracranial, and life threatening bleeds versus warfarin (p < 0.05). Dabigatran has advantages over warfarin including predictable pharmacokinetic/pharmacodynamic profile, minimal drug-drug and no drug-food interactions while no monitoring is needed.The 150 mg dose of dabigatran should be considered in younger patients with a low risk of bleeding and good renal function to achieve a superior ischemic stroke reduction, whereas, the 110 mg dose should be considered in elderly patients, those with mild to moderate renal function or those with high risk of bleeding.