Just days after the FDA said it had found that rates of gastrointestinal or intracranial bleeding were no more prevalent for patients taking the blood thinner Pradaxa than for those taking the old school warfarin, developer Boehringer Ingelheim released some long-term study results backing up that finding and potentially the drug's lead in the marketplace.
Calling the latest trial results "unexciting from a scientific point of view," Dr. Stuart Connolly, said the additional time--participants were tracked on average 4.3 years--shows that the efficacy and safety of the drug are maintained over at least four years and hopefully longer. "It's business as usual," but the findings are important, Dr. Connolly said in a telephone interview from the American Heart Association's Scientific Sessions 2012, where the results were released.
Dr. Connolly, a professor in the Department of Medicine at McMaster University, Ontario, Canada, pointed out that the FDA, after sorting through masses of insurance documents, came to essentially the same findings in an entirely different way.
Pradaxa is one of the new generation anticoagulants that don't have some of the nasty side effects of the workhorse, warfarin. Because Pradaxa has been shown to be more effective, it and others of these new blood thinners are expected to generate billions of dollars for the companies that have them. In fact, the competition for the class ratcheted up last week when the FDA approved Xarelto from Johnson & Johnson ($JNJ) and Bayer to be marketed to prevent clots in the legs and lungs. But some doctors remain skeptical of these drugs because unlike warfarin, there is no antidote for bleeding events. In fact, Pradaxa, which hit the blockbuster sales milestone this year, led the FDA's list of drug-related fatalities last year.
Dr. Connolly said the concern about antidotes misses the larger context. "If you use dabigatran you are going to prevent or significantly reduce the larger, more serious bleeds compared to warfarin and you are also going to reduce ischemic stroke, and the overall benefit would seem to clearly outweigh the concern that a patient might get into a situation, where they might need an antidote, that might have worked if they were on warfarin."
- here's the release
FDA backs Pradaxa safety as docs lament lack of antidote
Xarelto, Pradaxa find reprieve in Eliquis delay
EMA supports Pradaxa but seeks sharper warnings for bleeding
Pradaxa patient's death draws more scrutiny of bleeding risks
Pradaxa hits blockbuster mark, swelling Boehringer sales