xarelto-Bayer/JNJ
After reading some summaries of the NEJM data, I think you are correct, DEW, that Xarelto has considerable problems that may affect its commercial success, despite the favorable spin in the media today.
The biggest problem I see is that even for the lower 2.5 mg BID dose, the "major bleeding risk" is about 4X that for placebo (2.1% vs 0.6%). There was not a measurable risk of "fatal bleeding". But, from a clinical viewpoint, that makes little difference. Pt's and doctors for reasons that may be partly emotional, partly rational, and partly legal are very afraid of bleeding risk, especially intracranial hemorrhage. We saw this phenomenon with TPA and other thrombolytics.
The bleeding risk would be tolerated, of course, if the efficacy were high enough. But, the absolute survival benefit of treatment with riva was only 9.1 vs 10.7 for placebo or 1.8%. I don't have the statistics background to put forth the numbers needed to treat and harm, but my gut says the all important net clinical benefit may be very small.
There is also a problem now with dosing. Faced with data that even this small dose of Xarelto is associated with 4 fold major bleeding risk, how are we going to view the higher doses (I think it was 20 mg) approved for other indications such as A. fib? This drug has more testing to sort out how to use it, IMO.
By the way, anyone able to post numbers needed to treat for benefit and harm would be much appreciated.
Urche
AI
