Pradaxa promise in preventing clots in atrial fibrillation
Dabigatran or Dabi as it is now known has moved through the FDA (approved 10/19/10), the supplying phase to wholesalers and should now be available in your local pharmacy. This may be a true breakthrough for people trying to manage abnormal blood clots seen in a prevalent kind of abnormal heart rhythm known as atrial fibrillation (afib).
Afib challenges more than 2.3 million people in the US and beyond the thumping feeling they get in their chests, they are at significant risk for increased abnormal blood clots. Remember, a stroke, heart attack, deep vein thrombosis or pulmonary embolism are all clot (ischemic) problems where a blood vessel in the brain, heart, lags or arms or lung gets clogged by a clot.
When afib happens, you might feel dizzy or could pass out, but additionally—the blood pools in the heart and is likely to form a blood clot. Enter blood thinners (what your doctor would call anticioagulants). The oldest and best known blood thinner is warfarin (goes by the brand name Coumadin). The work your doctor has to do is to use this drug to get the blood less likely to clot (thinner) than normal—yet not so thin that you start to bleed without injury. The way they do this is to order lab tests (protime and a calculated number called an INR) and get the test into a range that usually prevents clots.
Pradaxa (dabigatran) is different because it goes to work very quickly AND does NOT require lab testing. Based on the RE-LY (randomized Evaluation of Long-Term Anticoagulant Therapy) study, the 150 mg dose actually prevented stroke and blood clots in the body (systemic emboli) BETTER than the older drug, warfarin. Pradaxa is more expensive than warfarin, but fares well when the cost of laboratory testing and warfarin are considered.
As usual, there is no magic bullet. One challenging piece of the Pradaxa Puzzle is what to do if someone is taking it and they have to go to emergency surgery. Warfarin (since it inhibits vitamin K dependent clotting factors) can be easily reversed. There are two possible products which might be used (FEIBA and PCC) to reverse Pradaxa, yet data on how best to use them and how much to give based on possible lab testing (ECT) is still not clear.
All in all, however, I expect that we will see a lot of use of Pradaxa, and I am planning a drug monograph for the Essential Guide to Prescription Drugs.
Approval Date:
Tue, 10/19/2010
Company:
Boehringer Ingelheim Pharmaceuticals