DR. PARKS: Dr. Wyne, are you referring to an advisor committee in July
2007? I think that’s the only thing I can think of where there was some discussion about
last couple of meetings of this committee, with respect to diabetes studies and events, is
weren’t we told that there tends to be an increase in events in the short-term, perhaps in
the first six months, but then if you follow the people out for two to three years you get a
decrease in the events in the treated group. So although it makes sense to me that there
should be more events the longer you follow people actually what I think we are seeing
here is even less events than we would have expected which maybe is a positive, that we
are not seeing that increase in events in the first six months that we have seen with so
many previous drugs.
risk in short-term trials versus long-term trials. If that is indeed then the problem is that
we are talking about not a single study or even a single data set here, they are two very
different data sets, this is specific to the rosiglitazone advisory committee. The meta-
analysis, which was comprised primarily of six months or shorter duration studies versus
long-term studies that were three years, you really can’t compare those two different data
sets to say that the risk was different over time. Joy, do you want to comment on that?
Also one thing that was confusing to me is my recollection from the
DR. BURMAN: Thank you. I would like for clarification of that from
any members of the FDA or the Sponsor respond to the second part of the question. I
analysis where we were seeing some early events and then the curves came together?
DR. WYNE: I actually think it was a meeting prior to that but what I
remember is a comment of, oh, yeah, this is typical in diabetes studies that we see an
don’t remember that myself...about there being less events in the longer term?
DR. MELE: I was just thinking of proactive actually. Didn’t we do some
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