have that provides some perspective on this would be the Kaplan-Meier curve; if we
could project slide 57 from the core deck. So, again, we look carefully at the time course
of when these events occurred and didn’t, our view of the data is that we did not see
evidence for increased harm for Saxagliptin either earlier or late. We looked at the same
sort of data for all cause mortality and saw a very similar pattern.
and retinopathy, where there was an increase originally and then in the end there was a
major benefit. I'm not really sure of an analogous situation in terms of cardiovascular
disease and diabetes. You know, it may be that a study like ACORD if it’s followed out
long enough will show some type of a benefit because the total event rates were lower in
the intensive group. I think the thing that frequently is referred to is the DCCT results.
of your question, if we can go back to that it, was whether those patients that have rescue
and if my memory serves me right it’s about 10-12% of people who were rescued are the
ones that had a higher rate of cardiovascular events. Can anyone address that issue either
from the FDA or the Sponsor? Please.
DR. BURMAN: Thank you. We will take a break at 2:30. the first part
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early increase in events but that it goes away over time. Macrovascular events, yeah,
not just microvascular events. It may just be it’s because that statement was lumping
together so many studies.
DR. BURMAN: Thank you. Dr. Wyne maybe you could follow up as
well. Did the Sponsor have a comment on that?
DR. WOLF: Given the limitations of our data set I think the thing that we
DR. SAVAGE: The thing that’s commented on frequently was the DCCT
DR. BURMAN: Does the FDA have any further comments on that? Dr.
Savage do you have a comment on that?