{"id":3994,"date":"2010-10-20T14:01:27","date_gmt":"2010-10-20T18:01:27","guid":{"rendered":"http:\/\/blogs.nejm.org\/cardioexchange\/?p=3994"},"modified":"2011-07-19T17:45:26","modified_gmt":"2011-07-19T21:45:26","slug":"dabigatran-is-approved","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/cardioexchange\/2010\/10\/20\/dabigatran-is-approved\/","title":{"rendered":"Dabigatran Is Approved"},"content":{"rendered":"

John Mandrola is a cardiac electrophysiologist and blogger on matters medical and general. Here is a recent post from his blog <\/em>Dr John M<\/em><\/a>.<\/em><\/p>\n

There can only be one cardiology story to\u00a0discuss today.<\/p>\n

Tuesday, the FDA\u00a0approved dabigatran<\/a> (Pradaxa), an oral anticoagulant for the prevention of stroke in atrial fibrillation.<\/p>\n

Previously, the only drug approved to prevent stroke in patients with AF was warfarin. Despite the well-known, sound scientific data in support of warfarin for the prevention of stroke \u2014 arguably one of life’s most tragic chapters \u2014 the\u00a0 adverse effects of warfarin precluded its unanimous acceptance. \u00a0From the beginning, warfarin was known\u00a0to be\u00a0the active ingredient in rat poison; this has been (and still is) a tall hurdle to overcome. Moreover, everyone seems to know someone who was “killed” by warfarin.<\/p>\n

And its history is not warfarin’s only weakness. It is a tricky drug to use. Moderating blood thinness requires a motivated patient and a motivated health care system.\u00a0For example,\u00a0even rigorous clinical trials \u2014 with their armies of clinical specialists\u2014only manage a TTR (time in therapeutic range) of 60%-70%. \u00a0Finally, we all know of the many unfavorable interactions\u00a0\u2014 drug-drug, drug-diet, and even drug-DNA (variable metabolism)\u00a0\u2014 of warfarin.<\/p>\n

So it is with great excitement that the medical community welcomes dabigatran, the first warfarin substitute. Congratulations Boehringer Ingelheim, it is your field of dreams, at least for the moment.<\/p>\n

Few U.S. clinicians have any real-life experience with dabigatran. \u00a0We will learn together. Without doubt, there will be great initial fanfare; I have already received two letters from Boehringer inviting me to be a featured speaker. It’s just a hunch, but I think the dabigatran launch will likely make the Multaq carnival look like a mere parish picnic.<\/p>\n

For use of\u00a0dabigatran in the real-world, outside the cocoon of carefully controlled clinical trials, much remains to be learned. Answers to questions like:<\/p>\n