Dabigatran (Pradaxa) to Prevent Strokes
Dabigatran (Pradaxa®) is an anticoagulant medication. The US Food and Drug Administration (FDA) approved dabigatran in October of 2010 to prevent strokes in those with atrial fibrillation, marking the first approval of an oral anticoagulant in more than 50 years.1
Dabigatran was approved based on the RE-LY trial, an international clinical study involving 18,000 people. Researchers compared the risk of stroke in people with atrial fibrillation taking either 150 mg or 110 mg of dabigatran to those taking warfarin.2
The results showed that participants taking the higher dose of dabigatran had lower stroke and blood clot rates than those taking warfarin with similar major bleeding rates. Those participants taking the lower dose of dabigatran had similar stroke and blood clot rates to those taking warfarin but lower rates of major bleeding. The FDA ultimately approved 150 mg and 75 mg doses of dabigatran.3 The rest of the world approved the 150 mg and 110 mg doses used in the RE-LY trial.
How it Works
Dabigatran is a direct thrombin inhibitor. It prevents the protein thrombin, which is involved in blood clotting, from working as it should. This, then, reduces the risk of blood clots.3
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The recommended dose of dabigatran for people with atrial fibrillation is 150 mg twice a day. A reduced dose of 75 mg is available in the US and 110 mg elsewhere in the world. The reduced dose is typically for those meeting one or more of these criteria: kidney disease,3,4,5 age of 80 years or more, increased bleeding risk, or use of verapamil.6
To learn more about who can and cannot take DOACs and what to know if you do, see Direct Oral Anticoagulants (DOACs).
What to Know If You Take Dabigatran
Here are things to know that are specific to taking dabigatran.
- Dabigatran costs more than warfarin, so you may have a higher out-of-pocket cost.
- Dabigatran should be kept dry by keeping it in its original container or getting it in individual blister packs.
- Dabigatran is metabolized by the kidneys, so it may not be the best choice if you have kidney disease.
- There is a higher risk of bleeding with dabigatran if you’re 75 or older, have kidney disease, a history of stomach or intestinal tract ulcers or bleeding, or take other medications that increase the risk of bleeding (such as aspirin or non-steroidal anti-inflammatories, like ibuprofen).3
- The other significant side effect of dabigatran is gastrointestinal issues such as nausea and heartburn. If you have this problem, your doctor may prescribe an over-the-counter or prescription medication to reduce stomach upset.
- While dabigatran has few interactions with medications, taking it with dronedarone (MULTAQ) can increase the effects of dabigatran.7 Your doctor or pharmacist can advise about how to avoid this. (It is often recommended to take them two hours apart.)
- If you need emergency surgery or have severe bleeding, doctors can reverse the effects of dabigatran by administering a reversal agent called idarucizumab (Praxbind®).8
- See What to Know If You Take a DOAC for things everyone on a DOAC should know, including potential medication and supplement interactions, signs of unusual bleeding, and what to know if you are asked to stop your dabigatran for a procedure or surgery.
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