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Dabigatran

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Dabigatran

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. It is commonly used to prevent blood clots following hip or knee replacement and in those with a history of prior clots. and is used as an alternative to warfarin; it does not require monitoring by blood tests. In a meta-analysis of seven different studies, there was no benefit of dabigatran over warfarin in preventing ischemic stroke; however, dabigatran was associated with a lower hazard for intracranial bleeding compared with warfarin, but also had a higher risk of gastrointestinal bleeding. It is taken by mouth.

Common side effects include bleeding and gastritis. Other side effects may include bleeding around the spine and allergic reactions such as anaphylaxis. In cases of severe bleeding, it can be reversed with the antidote, idarucizumab. Use is not recommended during pregnancy or breastfeeding. Compared to warfarin it has fewer interactions with other medications. It is a direct thrombin inhibitor.

Dabigatran was approved for medical use in the US in 2010. It is on the World Health Organization's List of Essential Medicines. In 2020, it was the 306th most commonly prescribed medication in the United States, with more than 1 million prescriptions. Dabigatran is available a generic medication.

Dabigatran is used to prevent strokes in those with atrial fibrillation not caused by heart valve issues, as well as deep vein thrombosis and pulmonary embolism in persons who have been treated for 5–10 days with parenteral anticoagulant (usually low molecular weight heparin), and to prevent deep vein thrombosis and pulmonary embolism in some circumstances.

It appears to be as effective as warfarin in preventing non-hemorrhagic strokes and embolic events in those with atrial fibrillation not due to valve problems.

In 2022, an observational meta-analysis study was performed on direct oral anticoagulants for patients with atrial fibrillation. The study found that dabigatran had comparable rates of ischemic stroke or systemic embolism, intracerebral haemorrhage, and all-cause mortality when compared to other anticoagulants like apixaban, edoxaban, and rivaroxaban. Notably, apixaban was associated with a lower risk of gastrointestinal bleeding than dabigatran and the others. This finding was generally steady for patients aged 80 years or older and those with chronic kidney disease.

Dabigatran is contraindicated in patients who have active pathological bleeding, since dabigatran can increase bleeding risk and can also cause serious and potentially life-threatening bleeds. Dabigatran is also contraindicated in patients who have a history of serious hypersensitivity reaction to dabigatran (such as anaphylaxis or anaphylactic shock). The use of dabigatran should also be avoided in patients with mechanical prosthetic heart valves due to the increased risk of thromboembolic events (such as valve thrombosis, stroke or myocardial infarction) and major bleeding when compared with warfarin.

Current US Food and Drug Administration guidelines states that patients with mechanical heart valves should not be using dabigatran. The safety and efficacy of Pradaxa (dabigatran) were evaluated in the European RE-ALIGN trial in 2012. RE-ALIGN was terminated early because the Pradaxa treatment group had significantly more thromboembolic events and major bleeding than warfarin and determined to be contraindicated for use in patients with mechanical heart valves. Further studies are needed in order to determine effects of dabigatran on patients with bioprosthetic valves.

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