More on ATryn ancient history:
[This is a repost of #16936 on the Yahoo GTCB board in reply to a new poster.]
>>Contrary to what the management is saying, it looks like ATryn has a higher rate of side effects than placebo.<<
You have to understand the context to make sense of those data. The old U.S. ATryn studies in the U.S. you referred to from the iHub post were very different from the current development program. A few comments:
1. The old U.S. ATryn trial studied CABG surgery with a *general* Heparin-resistant patient pool, i.e. not specifically patients who had an antithrombin hereditary deficiency (HD). This was a much different medical setting than the ATryn application pending in Europe (and the planned pivotal trial in the U.S.), which tested only HD patients undergoing elective surgery or childbirth.
2. Although there was a higher rate of SAE’s in the ATryn arms of the old U.S trials than in the placebo arms, the difference was not statistically significant.
3. The relevant safety issue for the ATryn application in Europe and the planned pivotal study in the U.S. is not whether ATryn is as safe as a placebo, but rather whether ATryn is as safe as plasma-derived antithrombin.
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