People suffering from arrhythmia are prone to stroke. Stroke may be prevented with the use of anticoagulants. Before September 2010, the most common prophylactic oral anticoagulants approved for this indication were aspirin and warfarin. Then came dabigatran…
Dabigatran etexilate was approved as Pradaxa in the US. PRADAXA (dabigatran etexilate mesylate) comes in capsules and “is a prescription medicine used to reduce the risk of stroke and blood clots in people who have a medical condition called atrial fibrillation.”
According the supporting clinical trial data, mainly from the RE-LY (Randomized Evaluation of Long-term anticoagulant therapy) study, dabigatran is better able to prevent ischemic strokes than warfarin in patients at high risk for stroke. In addition, dabigatran seems to be easier to use, with less complications (bleeding, hemorrhage) than warfarin. Warfarin is notoriously known to be a complicated drug to use which require close patient monitoring and genotyping patients for safer dosage.
Dabigatran is not really a new kid in the block. It is already used in Europe to prevent bleeding complications after certain surgical procedures. It is better accepted by patients than the heparin injections usually prescribed. However, the US is the first to approve for stroke prevention. Japanese health authorities approved it in January 2011.
Side effects and complications
The most common side effects reported for dabigatran are stomach problems. Precaution should be taken in combining with other anticoagulants.
Bleeding complications may occur
In addition, data from the RE-LY study indicate a small increase in the risk for having a heart attack associated with dabigatran.
Another study investigated the cost-effectiveness of dabigatran vs. warfarin and concluded:
“In patients aged 65 years or older with nonvalvular AF at increased risk for stroke (CHADS₂ score ≥1 or equivalent), dabigatran may be a cost-effective alternative to warfarin depending on pricing in the United States.”
Dabigatran is approved for stroke prevention in the US and is currently being reviewed in Canada and Europe for this similar indication.
When is it available?
In theory, dabigatran is already in use in the US and Japan for stroke prevention. In practice, doctors are still cautiously testing the waters as they do not want to compromise their patients’ health.
Hardly used and already expired? Dabigatran capsules in bottles should be used within 30 days after the container has been unsealed. To avoid this, go for the hermitically sealed individual capsules in blister packs. But make sure the blister is intact before you take a capsule!