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Dabigatran, sold under the brand name Pradaxa among others, is an anticoagulant used to treat and prevent blood clots and to prevent stroke in people with atrial fibrillation. [ 6 ] [ 7 ] Specifically it is used to prevent blood clots following hip or knee replacement and in those with a history of prior clots. [ 6 ]
Biotechnology developments then paved way for the first successful synthetic anticoagulants including hirudin. [6] The monitoring of warfarin and keeping the international normalized ratio (INR) between 2.0 and 3.0, along with avoiding over and under treatment, has driven a search for an alternative. [3] [14]
Dabigatran is an oral direct thrombin inhibitor. Dabigatran (Pradaxa) was found to be noninferior to Warfarin in prevention of ischemic stroke, as well as intracranial hemorrhage risk and overall mortality for non-valvular atrial fibrillation according to the RE-LY trial.
Idarucizumab is a monoclonal antibody, approved by the US FDA in 2015, that reverses the effect of dabigatran by binding to both free and thrombin-bound dabigatran. [ 116 ] [ 117 ] Andexanet alfa is a recombinant modified human factor Xa decoy that reverses the effect of factor Xa inhibitors by binding at the active sites of factor Xa inhibitor ...
The common side effect, a natural consequence of reduced clotting, is bleeding. [12] Less common side effects may include areas of tissue damage, and purple toes syndrome. [12] Use is not recommended during pregnancy. [12] The effects of warfarin are typically monitored by checking prothrombin time (INR) every one to four weeks. [12]
This score reflects the need to offer an improved patient care pathway when using oral anticoagulants. While NOACs avoid the need for drug monitoring (e.g. INR monitoring), they have an unstable bioavailability and are not indicated for patients with chronic kidney failure [7] or in patients with valvular replacement surgery. [8]
The normal range for a healthy person not using warfarin is 0.8–1.2, and for people on warfarin therapy an INR of 2.0–3.0 is usually targeted, although the target INR may be higher in particular situations, such as for those with a mechanical heart valve. If the INR is outside the target range, a high INR indicates a higher risk of bleeding ...
Dabigatran 110 mg was not inferior to warfarin for the primary efficacy endpoint of stroke or systemic embolization, while dabigatran 150 mg was significantly more effective than warfarin or dabigatran 110 mg. [19] Analyses by EMA demonstrated the benefits observed in the comparison of dabigatran to warfarin diminished if INR control was good ...
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