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Posted by on Nov 16, 2010 in Cardiology, Neurology, Pharma

Yabba-Dabigatran: Cheerleading for Pradaxa and What May Follow

Yabba-Dabigatran: Cheerleading for Pradaxa and What May Follow


For all the faults of the pharmaceutical industry (and there are many…and they are chiefly, if not solely, generated by industry marketers), it remains the site of medical innovation. In times of R&D drought, cynicism and finger wagging reign (thank you, Catherine DeAngelis, Marcia Angell, and Eric Campbell; it’s been one hell of an overbearing ride). But when breakthroughs occur, life in a free-market economy gets about as sublime as it can get.

With the FDA approval of Boehringer Ingelheim’s Pradaxa, patients with atrial fibrillation and their physicians now have the option to say “good riddance” to the old-as-dirt warfarin, along with its cumbersome monitoring and its pesky dose fiddling. More important, Pradaxa appears to be better at preventing stroke than warfarin in a-fib patients,* and it is not more likely to cause major bleeding, hemorrhagic stroke, or death. And Pradaxa, at its current pricing, actually appears to be cost-effective. Talk about win-win-win-win…I could go on. The only downside (at least for me) in all of this good news: BI is not a publicly traded company. This kind of innovation and company responsibility deserves investment, I say.

Forbes’s Matthew Herper (The Medicine Show) may be a little less giggly in his enthusiasm, but he anticipates a Pharma resurgence with the advent of several new anticoagulants, along with Pradaxa, that will likely replace warfarin treatment. Among these is Bayer Healthcare’s Xaralto (rivaroxaban), a direct factor Xa inhibitor, which may be as good as or better than warfarin for preventing stroke in a-fib patients, according to clinical data presented yesterday at the American Heart Association meeting. (Keep in mind, however, that these data have not been peer reviewed.) Other promising, warfarin-shunning candidates in development include apixiban (Pfizer/BMS), edoxaban (Daiichi Sankyo), and betrixiban (Merck).

* Although the pivotal trial, RE-LY, was powered as a noninferiority trial.

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A native East Tennessean, Barbara Martin is a formerly practicing, board-certified neurologist who received her BS (psychology, summa cum laude) and MD from Duke University before completing her postgraduate training (internship, residency, fellowship) at the Hospital of the University of Pennsylvania in Philadelphia. She has worked in academia, private practice, medical publishing, drug market research, and continuing medical education (CME). For the last 3 years, she has worked in a freelance capacity as a medical writer, analyst, and consultant. Follow Dr. Barbara Martin on and Twitter.