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Re: jq1234 post# 108970

Tuesday, 11/16/2010 3:24:34 AM

Tuesday, November 16, 2010 3:24:34 AM

Post# of 257251
Xarelto vs Pradaxa: After thinking about this a bit more, I now think Xarelto has a commercial edge (assuming it gets FDA approval on the first review cycle) because it was tested in a much sicker AF population than Pradaxa. The patients in the Xarelto ROCKET-AF study may have been the sickest population ever tested in a large cardiovascular study for any drug.

Had Xarelto been tested in Pradaxa’s relatively low-risk patient pool, I think Xarelto would probably have logged numbers as good as or better than Pradaxa’s observed numbers. Similarly, had Pradaxa been tested in a study similar to ROCKET-AF, I think it probably would have logged numbers not better and likely somewhat worse than Xarelto’s observed numbers.

Moreover, unlike Pradaxa, Xarelto is dosed qD and can be dosed full strength in renally impaired patients. Since a non-trivial proportion of the AF patient pool for these drugs has some degree of renal impairment, the above is a consequential differentiating factor, IMO.

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