Replies to post #131091 on Biotech Values

[genisi]

Edit to my previous post

The reduction of 9.1% in death from CV, MI, or stroke was for the 2.5mg dose not both doses. The combined reduction for both doses was 8.9%.

One more point that was mentioned in theheart.org article is the number-needed-to-treat-to-benefit (NNT) - 56 (one death prevented for every 56 patients treated for two years), which is quite good.

[genisi]

Given the significant reduction in death and the absolute major bleeding rates, I think the 2.5mg rivaroxaban dose has a good risk/reward profile in ACS.

Karen A. Hicks, M.D., the FDA reviewer seems to agree with this. From page 16 in the briefing docs:

I recommend approval of XARELTO® (2.5 mg po BID) to reduce the risk of cardiovascular events in patients with acute coronary syndrome (ACS)