DR. WOLF: I’m sorry. I don’t know the answer to that question.
DR. BURMAN: Thank you. Any other comments or questions by the
DR. WYNE: Can I clarify? What he is asking is, of those 40 events,
what’s the duration of disease in those people? Is it possible to see a breakdown with
those 40 events? What we want to know is, Are those events enriched in people who
DR. BURMAN: Does the Sponsor want to respond to that?
DR. WOLF: Could you repeat?
DR. BURMAN: Sure. Please repeat the question.
DR. LESAR: Sure, my question has to do with the use of concurrent
know, this is in the diabetes literature, the risk begins actually increasing at the ten-year
point. It’s continuous but it goes up more then. So if you have it for the ten-year, I
would love to see that.
have longer duration of disease? He is specifically using ten years as a break point
because that’s what the recent studies seem to indicate. Where I am disagreeing with him
is I think it’s a continuum where that increase in risk definitely picks up after five years,
probably around seven, but absolutely beyond ten years. So that’s what he is wondering.
Is it possible those events are all in people of more than ten years or is it evenly split?
DR. LESAR: Yes there was a discussion related to how many patients
were on Statins but I am also curious if there was balance and some measurement of
medications that might alter the frequency of cardiovascular events outside of Statins,
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Committee? Yes, Dr. Lesar.
other medications that might alter rates of cardiovascular events, either positive or
negative, such as Aspirin, Beta blockers, nonsteroidal anti-inflammatory drugs?
DR. TEERLINK: No, because I mean the cardiovascular events, you