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Re: DewDiligence post# 143966

Monday, 06/18/2012 11:53:01 AM

Monday, June 18, 2012 11:53:01 AM

Post# of 257566
Pradaxa similar to warfarin in peri-procedural bleeding rates, according to post hoc analysis of RE-LY study in patients with AF:

http://finance.yahoo.com/news/ly-sub-analysis-suggests-pradaxa-120000828.html

Peri-procedural was defined as the time starting 7 days before surgery and ending 30 days afterwards. During this period, 5.1% of Pradaxa patients and 4.6% of warfarin patients had major bleeds, a risk ratio of 1.09 (95% CI: [0.80, 1.48]), which was, of course, deemed non-statsig.

The purpose of this analysis from a marketing standpoint was presumably to show that the lack of a reversing agent does not put Pradaxa at a significant disadvantage to warfarin peri-procedurally.

Note: The FXa reversing agent being developed by Portola (#msg-76672265) will not work for Pradaxa, which is not an FXa inhibitor.

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